Motor and Cognitive Exercise in Parkinson's Disease.
ConditionParkinson Disease (PD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnnemette Lokkegaard
About this trial
The aim of this study is to examine the effects of a specialized multi-modal intervention in patients with moderate to advanced Parkinson's disease (PD). The hypothesis is that a specialized motor- and cognitive exercise program in addition to usual care can improve gait and balance better than usual care alone.
48 patients with PD and a symptom duration of 4 or more years will be randomized 1:1 to either a control arm or to an intervention arm. The control arm will have usual management of their PD. The intervention arm will receive exercises aimed at both motor and cognitive impairments of PD over the course of 12 weeks.
The study has been designed in partnership with the Copenhagen Trial Unit (CTU), Copenhagen Univeristy Hospital, to ensure both internal and external validity. To increase reproducibility, detailed protocols for all training modalities will be shared along with the study results.
This study is a feasibility study with the intention of a following international multi-center study to corroborate the results. Both feasibility outcomes for the intervention itself and clinical outcomes for the participants will be published.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of PD according to MDS-PD criteria
Aged ≥ 18 years
Informed consent
PD symptoms ≥ 4 years
Disqualifiers
Diagnosis of PD Dementia according to the MDS-PD Dementia criteria
Trial design
Design model
Parallel
Treatments tested in this trial
Motor-cognitive exercise
Other intervention3 weekly 1-hour sessions of motor-cognitive exercise. Each 1-hour session will be multi-modal with 20 minutes of dynamic balance training, 20 minutes of dual-task exercises while treadmill walking and 20 minutes of lower body strength training with leg press. Detailed protocols for the exercises will be published along with results.
Usual Care
Other interventionBest medical treatment: usual management of participants' PD and other potential comorbidities at the discretion of their regular physician and other health providers.
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: ControlActive comparator 1 intervention
Group B: InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility: Intervention adherence
Adherence defined as the proportion of participation in exercise sessions out of 36. A proportion of more than 60% will be considered acceptable.
Time frame
From allocation to the end of 12 weeks of intervention (T2)2
Exploratory composite clinical outcome: Significant fall, all-cause hospitalization and all-cause mortality
A composite outcome of either death, unplanned hospitalization or a significant fall. A significant fall will be defined as a fall leading to an unplanned hospital contact or contact with the general practitioner. This composite outcome is based on binary events that will be registered at each pre-specified follow-up time.
Time frame
From enrollment to 1-year follow-up (T4)Secondary outcomes
1
Feasibility: Missing data (primary clinical outcome)
Proportion of missing data on the exploratory primary clinical outcome "Significant fall, all-cause hospitalization and all-cause mortality". A proportion of less than 5% will be considered acceptable.
Time frame
From enrollment to 6-month follow-up (T3)2
Feasibility: Missing data (secondary clinical outcomes)
Proportion of missing data on the exploratory secondary clinical outcomes. A proportion of less than 10% will be considered acceptable.
Time frame
At baseline (T1), end of intervention at 12 weeks (T2), follow-up at 6 months (T3) and follow-up at 1 year (T4).3
Feasibility: Randomization rate
Screened compared to randomized. A rate of more than 70% randomized will be considered acceptable.
Time frame
From screening to baseline, up to 1 year.4
Feasibility: Drop-out rate
Drop-out at any time after enrollment. A drop-out of about 20 % is expected.
Time frame
Through study completion, an average of 1 yearOther outcomes
1
Exploratory secondary clinical outcomes
Hospital and institution free days
Time frame
Through study completion, an average of 1 year. The following time-points: Baseline, end of intervention at 12 weeks, follow-up at 6 months and follow-up at 1 year.2
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time frame
Through study completion, an average of 1 year. The following time-points: Baseline, end of intervention at 12 weeks, follow-up at 6 months and follow-up at 1 year.3
Montreal Cognitive Assessment (MoCA)
Time frame
Through study completion, an average of 1 year. The following time-points: Baseline, end of intervention at 12 weeks, follow-up at 6 months and follow-up at 1 year.4
Short Falls Efficacy Scale (Short-FES)
Time frame
Through study completion, an average of 1 year. The following time-points: Baseline, end of intervention at 12 weeks, follow-up at 6 months and follow-up at 1 year.Locations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Department of Neurology, Bispebjerg and Frederiksberg HospitalRecruiting2400, Copenhagen NV
Denmark
DenmarkSponsors and contacts
Click on the lead sponsor to view all of their trials.
Annemette Lokkegaard
Lead sponsor
University Hospital Bispebjerg and Frederiksberg
Sponsor institution
Copenhagen Trial Unit, Center for Clinical Intervention Research
Collaborator
Source ClinicalTrials.gov