Physical Disability

19

Review clinical trials related to Physical Disability. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Frailty, Physical Capacity and Lung Function in Postoperative Pulmonary Endarterectomy Patients

The goal of this observational and prospective study is to investigate changes in physical performance, lung function, respiratory and peripheral muscle strength in patients during the postoperative period following pulmonary endarterectomy (PET).

Participants needed: 50
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: University of Sao Paulo General HospitalUpdated: Jun 22, 2026Locations: 1
Eligibility criteria

Age ≥ 18 years [+3]

Reoperation for any reason [+1]

Status: Recruiting

Effect of Mobilization With Movement in Patients With Rotator Cuff Lesions

This randomized controlled trial aims to investigate the effects of Mobilization with Movement (MWM) on pain and functional status in individuals with rotator cuff lesions. Rotator cuff pathology is a common cause of shoulder pain and functional limitation, and impairments in proprioception may further compromise shoulder motor control and recovery. Eligible participants with rotator cuff lesions will be randomly allocated into three groups: (1) Mobilization with Movement (MWM), (2) conventional physiotherapy, and (3) control group. All participants will be evaluated before and after the intervention period. Outcome measures will include shoulder-related functional disability assessed by the QuickDASH questionnaire, pain intensity, and shoulder joint position sense evaluated using an active repositioning test with a laser pointer during shoulder flexion. The study is designed to determine whether MWM provides additional benefits over conventional treatment or task oriented training intervention in improving pain, function, and proprioceptive accuracy. The findings are expected to contribute to evidence-based conservative rehabilitation strategies for patients with rotator cuff lesions.

Participants needed: 75
Trial details
Age: 18-65Biological sex: AllType: InterventionalSponsor: Kirsehir Ahi Evran UniversitesiUpdated: Jun 8, 2026Locations: 1
Eligibility criteria

Age between 18 and 65 years [+5]

History of shoulder surgery on the affected side [+9]

Status: Recruiting

Frame Running for Exercise and Participation for Children and Young People With Physical Disabilities

The goal of this quasi-experimental single-arm trial is to evaluate whether a structured Frame Running training program can improve functional ability, participation, and quality of life in children and young people with physical disabilities. The study includes participants aged 8-18 years with cerebral palsy or other conditions causing physical disabilities. The aim of the study is to investigate changes in the primary outcome measure; functional ability using the Pediatric Evaluation of Disability Inventory - Computer Adaptive Test (PEDI-CAT), and a series of secondary outcome measures on mobility capacity, physical endurance, performance of everyday activities, and health-related quality of life in children and young people with physical disabilities. Participants will complete a 24-week training program carried out in community athletics clubs: 12-week low-intensity control period with one supervised weekly Frame Running session focused on familiarization. 12-week moderate-to-high intensity intervention period with two weekly training sessions, including warm-up, technique training, endurance and speed intervals, and participation-focused activities. Data collection comprises four standardized questionnaires, four physical performance tests conducted at multiple time points, an electronic training diary, and Rating of Perceived Exertion-Pediatric Scale (RPE-P) obtained before and after selected endurance tests.

Participants needed: 35
Trial details
Age: 8-18Biological sex: AllType: InterventionalSponsor: Odense University HospitalUpdated: Apr 29, 2026Locations: 1
Eligibility criteria

Children and adolescents aged 8-18 years. [+4]

Severe visual and/or cognitive impairments that would compromise safe participat... [+1]

Status: Recruiting

Evaluating the Impacts of a Single Session of Robot Assisted Gait Training With a Trexo

Early use of robotic gait trainers have shown many benefits, however why these benefits occur and how to maximize them is unknown. There are a few options for how a robotic gait trainer can be used, however, there is not much understanding of how these options impact rehabilitation and compensate for impairments. The investigators aim to evaluate the impacts of as single session of Trexo robotic gait training and the impact of different modes of the Trexo robotic gait trainer. The investigators will evaluate how the different settings impact things like physical activity, walking, brain activity, spasticity, and fatigue. Investigators will arrange for a familiarity and fitting session to start, so that study team members can fit the participant to the Trexo and so that participants can become familiar with the feeling of using the Trexo robotic gait trainer. After the initial fitting sessions, follow up sessions will be completed to evaluate different settings on the Trexo, for example in "endurance" mode (where the robot completes the movements for the participant) and in "strength" mode (where the robot requires some assistance from the participant). Investigators may also test different fitting settings, for example with and without the supportive seat in the Trexo. Only three visits are required (one fitting/familiarity session and two testing sessions), however participants and/or their families may choose to complete more testing sessions if they want to assess other aspects of the training. For example, if the first two testing sessions assessed physical activity, participants and their families may choose to return for further sessions to assess brain activity. The aim of the study is to determine how robot assisted gait training impacts rehabilitation and compensates for impairments, as well as to provide suggestions on how the robotic gait trainer might be improved or modified. This study is exploratory to find out more about how these robotic gait trainers, specifically the Trexo, impacts various aspects of rehabilitation.

Participants needed: 50
Trial details
Age: 4+Biological sex: AllType: InterventionalSponsor: University of CalgaryUpdated: Feb 6, 2026Locations: 1
Eligibility criteria

Able to fit into the Trexo robotic gait trainer (<150 lbs., <5'7"). [+1]

>150 lbs. [+2]

Status: Recruiting

Wheelchair User Physical Activity Training Intervention to Enhance Cardiometabolic Health

The goal of the study is to improve cardiometabolic health outcomes for wheelchair users and identify strategies for achieving sufficient physical activity intensity during bouts of structured physical activity.

Participants needed: 108
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Washington University School of MedicineUpdated: Jan 29, 2026Locations: 1
Eligibility criteria

Age 18 years or older [+7]

Determination by their physician to be medically unstable [+4]

Status: Not yet recruiting

Comparison of Two Park-Based Activities on Emotional Well-Being in Adults With Mobility Impairments

This study will examine the impact of a 10-week crossover urban park intervention on the emotional well-being of people with mobility impairments. Outcomes between 5 weeks of sensory engagement activity (i.e., enjoy sights, sounds; primarily sedentary) and 5 weeks of physical activity (i.e., wheeling/walking on trail) while in the park will be compared.

Participants needed: 10
Trial details
Age: 18-60Biological sex: AllType: InterventionalSponsor: University of Alabama at BirminghamUpdated: Jan 23, 2026
Eligibility criteria

(1) ages between 18 and 60 years [+3]

(1) bald or not willing to donate a hair sample [+8]

Status: Not yet recruiting

Using Art Participation to Promote Psychosocial Health Among People With Physical Disabilities: A Feasibility Study

This study aims to explore the feasibility of a newly developed theory-based inclusive art participation program for promoting psychosocial health of people with physical disabilities living in residential care homes. Specifically, the feasibility is assessed following the framework proposed by Bowen et al. (2009), which encompassed five aspects, including demand, implementation, practicality, preliminary effects, and acceptability. As for the preliminary effects, this project will evaluate self-esteem, sense of control, self-efficacy, mood, and social connectedness after the completion of program. This study will adopt a one group pretest-posttest approach with quasi-experimental design to collect both quantitative and qualitative data, employing a mixed-methods study design.

Participants needed: 50
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: The Nethersole School of NursingUpdated: Jan 20, 2026
Eligibility criteria

aged 18 years old or above [+6]

individuals with severely impaired speaking, hearing, or visual acuity [+2]

Status: Recruiting

Integrating AI in Postural Rehabilitation for Parkinson's Disease

Postural abnormalities are highly disabling complications of Parkinson's disease (PD). These include camptocormia, anterocollis, and Pisa Syndrome (PS). PS is characterized by a lateral trunk flexion (LTF) typically exceeding 10 degrees, often accompanied by axial rotation, asymmetric shoulder positioning, and poor awareness of the postural alteration. This condition worsens during upright activities and improves in a supine position. Patients with PD and PS are characterized by more pronounced motor asymmetry, a disorganized trunk muscle activity, back pain, balance issues, and reduced quality of life compared to PD patients without postural disorders. Camptocormia, another disabling postural anomaly, involves an anterior trunk flexion that also improves when lying down. Both PS and camptocormia are challenging to treat, with limited and short-lasting benefits from current multidisciplinary approaches, including medication, physiotherapy, botulinum toxin injections, and transcranial direct current stimulation (tDCS). Given the limitations of traditional rehabilitation strategies, there is a growing need for innovative and personalized approaches. In this context, advanced technologies such as artificial intelligence (AI) offer new possibilities for home-based treatment. This study aims to evaluate the feasibility of using a real-time visual feedback system powered by AI as a complementary intervention following inpatient neurorehabilitation for PD patients with trunk postural disorders (PS or camptocormia). A secondary objective is to assess whether an AI-guided, personalized exercise program can help maintain improvements in posture, mobility, and quality of life in the medium term. By integrating quantitative and qualitative outcomes, this study seeks to fill a gap in the literature and explore the potential of AI-driven home rehabilitation to support long-term functional gains and foster greater independence and well-being in people with PD.

Participants needed: 20
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: IRCCS National Neurological Institute "C. Mondino" FoundationUpdated: Jun 8, 2025Locations: 1
Eligibility criteria

Age above 18 years [+4]

Atypical parkinsonian syndromes [+8]

Status: Recruiting

Physical Activity on Neuroinflammation in Parkinson's Disease

Parkinson's Disease (PD) is a chronic progressive neurodegenerative disorder clinically defined by the association of resting tremor, rigidity, bradykinesia, and postural instability. The histopathology of PD is characterized by the loss of neurons in the substantia nigra pars compacta (SNPc) and the accumulation of α-synuclein aggregates within Lewy bodies. The pathogenic mechanisms underlying the development of the disease, however, are not yet fully understood: genetics, cellular oxidative stress, mitochondrial dysfunction, environmental factors, and neuroinflammation are all potential mechanisms involved in the pathogenesis of PD. Several studies have now established the involvement of neuroinflammation in the pathogenesis of PD. It is known that α-synuclein aggregates stimulate microglia and astroglia to secrete pro-inflammatory mediators such as IL 1β, IL6, and TNFα. These molecules activate an inflammatory response characterized by altered blood-brain barrier permeability, leukocyte recruitment, and the expression of other pro-inflammatory cytokines. These events contribute to exposing neurons to oxidative stress and cellular damage. Additionally, cellular damage induces neurons to stimulate the release of DAMPs (Damage Associated Molecular Patterns), which in turn activate glial cells. This creates a state of chronic inflammation that could play a role in the progression of the disease. Supporting this hypothesis, elevated levels of IL1β, IL6, and TNFα have been found in the striatum and SNPc of post-mortem PD samples. The transcription factor Nrf2 is one of the main regulators of cellular protection in response to stress (inflammation, redox, xenobiotics). Nrf2 promotes the expression of several genes that cooperate in a cytoprotective response, which includes antioxidant defense, resolution of inflammation, increased mitochondrial activity, and protein turnover. Recent clinical studies seem to confirm the hypothesis that Nrf2 plays a role in the pathogenesis of PD, as already suggested by preclinical models. Specifically, altered plasma levels of the Nrf2-activated pathway have been observed in preclinical models. Studies conducted on animal models of PD have hypothesized how exercise might correlate with protective mechanisms and might promote neuroplasticity and neuro-regeneration, especially when practiced at high intensity. Physical exercise can indeed modulate various systems (including inflammatory pathways and oxidative stress) that regulate neuroinflammation and glial activation. However, the available results are not definitive and often focus on single and separate aspects of the disease. The aim of the study is to investigate the beneficial effect of physical exercise in patients with Parkinson's Disease (PD). Literature already suggests an improvement in various domains of motor and non-motor aspects, as well as in the overall quality of life, of PD patients even after a period of aerobic activity. Generally, training periods included 3-4 sessions per week of 40-60 minutes each for 4-16 weeks. In general, the literature describes the effects of moderate physical training, while little or nothing is known about how PD is affected by high-intensity sports training. The primary objective of our study is to compare a group of PD patients undergoing regular and constant intense exercise (PD-sport) with a control group consisting of PD patients leading a sedentary life (PD-sedentary). The primary outcome will be the difference in systemic inflammatory status between the PD-sport group and the PD-sedentary group.

Participants needed: 40
Trial details
Age: 40-80Biological sex: AllType: ObservationalSponsor: IRCCS National Neurological Institute "C. Mondino" FoundationUpdated: May 18, 2025Locations: 1
Eligibility criteria

Subjects of both sexes, aged between 40 and 80 years (extremes included) [+2]

Concomitant diagnosis of other neurological diseases [+10]

Status: Not yet recruiting

Developing a Nonpharmacological Pain Intervention for Community-dwelling Older Adults With Dementia

The purpose of this study is to develop an exercise treatment program for knee osteoarthritis that works well for people with memory problems. This study will include two parts. Participants can choose to participate in either or both parts. In Part 1 (not a clinical trial) - The investigators are inviting the following people to participate in an interview: 1. Individuals aged 60 years or older who do not live in a nursing home and have both memory issues and knee pain. 2. Care partners of people with knee pain and memory issues. A care partner can be a family member or friend who helps regularly. 3. Clinicians (exercise physiologists or rehabilitation therapists like physical and occupational therapists) who have worked with older adults with memory issues and knee pain. The goal of these interviews is to learn from the experiences of people with memory issues and knee pain and those who care for them. From these interviews, the investigators hope to design a non-drug, tailored physical activity program that will be interesting and helpful in managing knee pain for older adults with memory problems. For people with memory problems and knee pain and their care partners: The investigators will ask some questions to determine eligibility to participate in the study. Those who qualify for the study will be invited to participate in an interview that could be completed online or in person (Philadelphia, PA). The interview could last up to 90 minutes (1 and a half hours) and can be completed as one or multiple sessions. For clinicians: Participants will engage in a 90-minute focus group with other clinicians where lunch will be served if in person. Those participating in an online focus group will receive a gift card equal to the value of lunch. In Part 2 (a clinical trial) - The program developed in Part 1 will be tested. The program will be physical activity-based. Specific program details for part 2 will be provided as they emerge. Participants can choose to sign up for either or both parts. Signing up for Part 1 does not mean participants have to sign up for Part 2. Please contact us for any questions.

Participants needed: 40
Trial details
Age: 60+Biological sex: AllType: InterventionalSponsor: Drexel UniversityUpdated: Mar 11, 2025Locations: 1
Eligibility criteria

Age 60 or older [+4]

Reside in long term care facility [+15]

Status: Recruiting

Using Augmented Reality to Promote Physical Activity in Children With Cerebral Palsy

Children with cerebral palsy (CP), Gross Motor Functional Classification Scale (GMFCS) I-II will be recruited to participate in a home based physical activity intervention for 4 weeks. Demographic data will be collected, and validated surveys assessing baseline physical activity level and mobility will be completed. Participants will have an exercise program assigned and will be given a logbook to record their exercise adherence. They will be assigned to the Augment Reality (AR) app group. The AR app group will have exercises administered through the AR app. At the end of the program, participants will complete final surveys and an exit interview.

Participants needed: 30
Trial details
Age: 5-18Biological sex: AllType: InterventionalSponsor: Children's Hospital Los AngelesUpdated: Jan 20, 2025Locations: 1
Eligibility criteria

Diagnosis of cerebral palsy, [+3]

Moderate to severe developmental or cognitive delay [+2]

Status: Recruiting

Awareness Detection and Communication in Disorders of Consciousness

STUDY OVERVIEW Brain injury can result in a loss of consciousness or awareness, to varying degrees. Some injuries are mild and cause relatively minor changes in consciousness. However, in severe cases a person can be left in a state where they are "awake" but unaware, which is called unresponsive wakefulness syndrome (UWS, previously known as a vegetative state). Up to 43% of patients with a UWS diagnosis, regain some conscious awareness, and are then reclassified as minimally conscious after further assessment by clinical experts. Many of those in the minimally conscious state (MCS) and all with unresponsive wakefulness syndrome (UWS) are incapable of providing any, or consistent, overt motor responses and therefore, in some cases, existing measures of consciousness are not able to provide an accurate assessment. Furthermore, patients with locked-in syndrome (LIS), which is not a disorder of consciousness as patients are wholly aware, also, struggle to produce overt motor responses due to paralysis and anarthria, leading to long delays in accurate diagnoses using current measures to determine levels of consciousness and awareness. There is evidence that LIS patients, and a subset of patients with prolonged disorders of consciousness (DoC), can imagine movement (such as imagining lifting a heavy weight with their right arm) when given instructions presented either auditorily or visually - and the pattern of brain activity that they produce when imagining these movements, can be recorded using a method known as electroencephalography (or EEG). With these findings, the investigators have gathered evidence that EEG-based bedside detection of conscious awareness is possible using Brain- Computer Interface (BCI) technology - whereby a computer programme translates information from the users EEG-recorded patterns of activity, to computer commands that allow the user to interact via a user interface. The BCI system for the current study employs three possible imagined movement combinations for a two-class movement classification; left- vs right-arm, right-arm vs feet, and left-arm vs feet. Participants are trained, using real-time feedback on their performance, to use one of these combinations of imagined movement to respond to 'yes' or 'no' answer questions in the Q\&A sessions, by imagining one movement for 'yes' and the other for 'no'. A single combination of movements is chosen for each participant at the outset, and this participant-specific combination is used throughout their sessions. The study comprises three phases. The assessment Phase I (sessions 1-2) is to determine if the patient can imagine movements and produce detectable modulation in sensorimotor rhythms and thus is responding to instructions. Phase II (sessions 3-6) involves motor-imagery (MI) -BCI training with neurofeedback to facilitate learning of brain activity modulation; Phase III (sessions 7-10) assesses patients' MI-BCI response to closed questions, categorized to assess biographical, numerical, logical, and situational awareness. The present study augments the evidence of the efficacy for EEG-based BCI technology as an objective movement-independent diagnostic tool for the assessment of, and distinction between, PDoC and LIS patients.

Participants needed: 30
Trial details
Age: 10-80Biological sex: AllType: InterventionalSponsor: University of UlsterUpdated: Dec 13, 2024Locations: 18
Eligibility criteria

Disorder of consciousness or low awareness state diagnosis ranging from unclear... [+1]

Participants with brain related diseases or illnesses (e.g., progressive neurolo... [+3]

Status: Recruiting

Effect of Additional Treatment With NMES After Achilles Tendon Rupture

Increased knowledge is needed about new methods how to treat patients with Achilles tendon ruptures (ATR). A goal is to be able to individualize as well as improve treatment beyond the question about if surgery should be used or not. An overall aim of the project is to, in a randomized controlled trial (RCT), explore what impact a new treatment method with Neuromuscular Electrical Stimulation (NMES) - attached on the patients ́ calf muscles on the injured leg - in the early stages after an ATR, may have on tendon length, functional performance, biomechanical variables and patient reported outcome, both in the short and long term after the injury. 70 patients are planned to be included in this RCT and will be evaluated 3,6 and 12 months after their injury. Primary outcome will be heel-rise height. Secondary outcome will be tendon length, jumping ability, patient- reported outcome and biomechanical loading pattern. There is also a need to explore if the patients ́ loading patterns improve after treatment with NMES. Therefore, biomechanical variables in lower leg during walking and jumping will also be evaluated one year after their injury. The planned studies include completely new ways of exploring how to optimize the rehabilitation after an ATR. Since there might be an increased risk for overuse injuries in the healthy limb, there will also be focus on how the non- injured limb may be affected of an ATR. Taken together, this new knowledge can be helpful in the clinical setting to individualize and optimize patients' treatment and rehabilitation with the goal to guide the patient return to the same, or higher level of, physical activity as before the injury.

Participants needed: 70
Trial details
Age: 18-65Biological sex: AllType: InterventionalSponsor: Vastra Gotaland RegionUpdated: Nov 14, 2024Locations: 1
Eligibility criteria

Achilles Tendon rupture [+2]

Pregnancy [+8]

Status: Recruiting

Pilot Study of a Multidisciplinary Intervention in ICU Survivors At Risk for Psychological or Physical Morbidity

Pilot study of the feasibility and utility of an early, in-hospital multidisciplinary intervention in ICU survivors at risk for psychological and physical problems post-ICU stay

Participants needed: 60
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Region StockholmUpdated: Oct 9, 2024Locations: 2
Eligibility criteria

Dementia or other major cognitive problems [+3]

Status: Recruiting

Effect of Multicomponent Exercises VIVIFRAIL® in Older Adults

This study employs a randomized, controlled, paired, single-blind clinical trial design. The targeted demographic comprises individuals aged 60 and above. Following the initial assessment, participants will be randomly allocated to two groups: the Intervention Group (ViviFrail) and the Group Suggestions for a Healthy Life (CG), maintaining a 1:1 allocation ratio. Both the ViviFrail group and CG group will exhibit homogeneity in terms of their clinical characteristics and functional performance. The allocation of participants into respective groups will remain concealed from all assessors, ensuring a single-blind approach. In the intervention group (ViviFrail), 25 participants will be instructed to engage in tailored physical exercises outlined in the VIVIFRAIL® protocol within the confines of their homes, with adaptations made according to their clinical conditions and functional performance. Conversely, the Group Suggestions for a Healthy Life (CG) comprising 25 participants will receive exercise suggestions and guidance to maintain a healthy routine for a duration of three months. Subsequently, participants in the CG will undergo the VIVIFRAIL® program intervention for an additional three months.

Participants needed: 50
Trial details
Age: 60+Biological sex: AllType: InterventionalSponsor: Pontificia Universidade Católica do Rio Grande do SulUpdated: Jun 6, 2024Locations: 4
Eligibility criteria

Eligible participants are older adults of both genders, aged at least 60 years. [+2]

Participants with scheduled surgeries or procedures within the next eight months... [+14]

Status: Recruiting

Movement and Behaviours Measurement Study

There are few studies that already have validated specific raw accelerometer cut-points for people over 65 years old. The purpose of the present study is to validate raw accelerometer cut points for general people over 65 years old and specific raw accelerometer cut points based on the functional status of older adults over 65 years old. The study will be carried out with an observational approach. Participants will be divided into 4 groups. First of them will be made grouping all subjects and the rest divided according to their functional status. They will perform different-intensity physical activities while wearing accelerometers attached to their body and wearing a portable gas analyser too. Their intensity will be assessed based on their own Rest Metabolic Rate (RMR). Energy expenditure and accelerations will be matched and, based on that, sedentary behaviour, light physical activity and moderate-to-vigorous physical activity cut-points will be derived.

Participants needed: 90
Trial details
Age: 65+Biological sex: AllType: ObservationalSponsor: University of Castilla-La ManchaUpdated: May 8, 2024Locations: 1Duration: 1 Day
Eligibility criteria

65 years and older [+2]

Have started an exercise program. [+2]

Status: Recruiting

Effect of Home-based Training Program for Kidney Transplant Recipients (HOMETRAIN-KTR)

Does home-based training work in kidney transplant recipients with reduced physical function? The goal of this clinical trial is to learn if home-based training works to better physical function in adult kidney transplant recipients. It will also learn about participants preoperative physical function. The main question it aim to answer is * Does home-based training improves physical function in kidney transplant recipients. * All the participants are assessed to have reduced physical function before the transplantation Participants will: * follow either a home-based training program or todays standard of physical activity after kidney transplantation * the program starts 4 weeks after the transplantation and lasts for 12 weeks. A physiotherapist will help the participants in the beginning. * the program consists of both cardio-training, strength-straining and optional activity * the training group will be followed up every week by phone. Their activity will be documented via patients logs and heart rate monitor. * the effect of the training will be evaluated one year after the transplantation

Participants needed: 200
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Oslo University HospitalUpdated: Apr 24, 2024Locations: 1
Eligibility criteria

Being 18 years old or older and going through Ktx [+4]

Status: Recruiting

YOOMI: Effect of Gamified Physical Therapy Exercise Software on Inpatient Mobility

Patients admitted to the hospital often develop functional impairments due to being in bed most of the day. Each day of bedrest leads to significant muscle loss. As a result, many patients become dependent on others or require rehabilitation at a facility to improve mobility and function prior to returning home. Staff in the hospital is limited and often unable to mobilize patients every day while hospitalized. The investigators are testing a new experimental gamified physical therapy exercise software to see if it can be a fun, enjoyable way to help mobilize patients without the assistance of staff. The primary aim of this pilot/proof of concept study is to determine whether gamified physical therapy software can help inpatients exercise within the safety of their own beds and preserve pre-hospitalization function.

Participants needed: 80
Trial details
Age: 65+Biological sex: AllType: InterventionalSponsor: Rutgers, The State University of New JerseyUpdated: Mar 8, 2024Locations: 1
Eligibility criteria

>= 65 years of age [+4]

Unstable Psychiatric Illness [+4]

Status: Recruiting

Structured Program of Exercise for Recipients of Kidney Transplantation

Older patients with end- stage kidney disease (ESKD) are at very high risk for functional impairment. Kidney transplantation (KT) has the potential to ameliorate the detrimental effects of ESKD on physical activity and functional status. However, KT alone may not meet the full extent of this potential, particularly for older or more impaired adults. In fact, activity declines immediately post-KT and fails to return to expected levels even 5 years post-KT. Older patients waitlisted for KT (most of whom are on dialysis) are therefore reliant on their pre-KT levels of exercise, which are also predictive of post-KT mortality. "Prehabilitation" has been used in other surgical populations to minimize functional loss, and a structured exercise program may be beneficial in the pre- KT setting. However, few waitlisted patients are able to participate in typical exercise interventions due to barriers such as severe fatigue. Older patients have additional barriers such as further mobility impairment and requiring substantial caregiver support. Therefore for older living donor kidney transplant candidates, it is necessary to address issues such as specifics of coaching, timing, and importantly, incorporate caregiver participation. The overall objective of this proposal is to adapt a previously developed 8- week, home- based, structured exercise program among older (≥50 years) dialysis patients awaiting living donor KT, with a focus on caregiver involvement. The investigators will trial the exercise program as compared to usual care. The investigators will then pilot the refined intervention in a total of 72 patient-caregiver dyads, 48 of whom will undergo the proposed intervention (24 with caregiver participation, 24 without). The primary outcomes for the pilot will be change in physical performance and activity from baseline to after the intervention, along with measurements of exploratory quality of life outcomes. In addition, the investigators will measure these same outcomes at 3- months post KT to evaluate for a durable effect of the intervention. An additional post-transplantation outcome of interest will be number of days hospitalized within 3 months of transplantation.

Participants needed: 136
Trial details
Age: 50+Biological sex: AllType: InterventionalSponsor: University of California, San FranciscoUpdated: Oct 16, 2023Locations: 1
Eligibility criteria

On hemodialysis or peritoneal dialysis [+5]

Already in an exercise program [+1]