Effect of Pneumatic Compression on Diaphragmatic Excursion in Hemodialysis Patients With Low Back Dysfunction

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-60
SponsorCairo University

About this trial

This study will be conducted to investigate any significant effect of pneumatic compression on diaphragmatic excursion in patients with low back dysfunction .

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients have been on regular hemodialysis (three sessions a week) at least 6 months before the start of the study

Patients 'Age between 40 and 60 years old

Patients have not participated in any physical activity program at least 6 months before the start of the study

Patients have chronic back pain > 3months

Disqualifiers

Instability of patient's medical condition

Patients with chest infection

Inability to comprehend and follow instructions as in dementia or speech problems such as dysphasia,

uncontrolled diabetes mellitus,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pneumatic compression device

    Device

    Training program in the form of resisted inspiratory exercises using pneumatic compression device with abdominal sleeve on the top portion of the abdominal cavity beneath the xiphoid process. The patient used a pursed-lip breathing method to exhale after inhaling slowly through the nose such that the stomach slid out against the abdominal sleeve of the device. For 12 weeks, three times per week, the workout consisted of 10 sets with 4-5 breaths in each set and a rest period of 2-3 minutes.

  • Inspiratory muscle Trainer

    Device

    the subject underwent training in the form of six sets of five deep breaths against the trainer, with 1-2 minutes of rest in between sessions. Depending on their rate of perceived exertion, the patient determined the maximum training load at which they could effectively perform 10 breaths at maximum resistance. A load equivalent to 30% of the patient's maximum inspiratory effort was used to begin the training .This unique load gradually increased as the inspiratory muscle got stronger. At the conclusion of the three months, the training programmer had expanded by 5% to 10% per week, reaching 60% of the maximum inspiratory pressure.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Pneumatic compression and inspiratory muscle Trainer groupExperimental treatment 2 interventions
Group B: Inspiratory muscle Trainer groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Diaphragmatic excursion

Ultrasonography is an ideal tool and easy to be operated for evaluating diaphragm function. Low thickening ratio at forced respiration is an early indicator of diaphragm dysfunction and is associated with adverse clinical outcomes in hemodialysis (HD) patients. These findings suggest that routine screening for diaphragm dysfunction is in HD patients and intervention of diaphragm dysfunction is expected to be a novel strategy for improving the clinical outcomes in HD patients.

Time frame
12 weeks
2

Pain intensity

Visual analogue scale (VAS) will be used to assess pain intensity. it is 10 centimeter line with 2 ends; 0 indicates no pain and 10 indicates the worst pain.

Time frame
12 weeks
3

functional capacity

The 6 Minute Walk Test (6MWT) is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. The patient will rest comfortably for 10 minutes prior to the test. During this time blood pressure and heart rate are measured and potential contraindications assessed. The 6MWT will be performed on the walking track in which is 30 meters on one lap and two small cones will be used to mark the walking track boundaries.

Time frame
12 weeks

Secondary outcomes

1

Functional disability

The Oswestry Disability Index (ODI) has become well-researched gold standard for assessing the severity of disability caused by back pain. The ODI covers 1 item on pain and 9 items on activities of daily living (personal care, lifting, walking، sitting, standing, sleeping, sex life, social life, and traveling. Each section contains 6 statements scored from 0 to 5, where 0 is no disability and 5 is the maximum. Scores are calculated as a percentage: (Total Points ÷ Total Possible Points) × 100.

Time frame
12 weeks
2

Health-related Quality of life

The SF-12 Health Survey Questionnaire is used to evaluate the health-related quality of life (HR-QoL) before and after the interventions. The SF-12 consists of 12 questions that examine eight different health domains in order to determine physical and mental health. General Health (GH), Physical Functioning (PF), Role Physical RP), and Body Pain (BP) are the physical health domains. Vitality) VT), Social Functioning (SF), Role Emotional (RE), and Mental Health (MH) are mental health-related scales. A score above 50 indicates better-than-average health, while a score below 50 indicates below-average perceived health.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

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