The Effects of an Intradialytic Yoga-Resistance Exercise on Muscle Strength, Fatigue, Depression, and Sleep Quality in Hemodialysis Patients: a Randomized Controlled Trial
Trial ID: NCT05535114
Status: COMPLETED
Study type: INTERVENTIONAL
Phase: NA
Start date: 2023-07-13
Completion date: 2023-10-15
Sponsor: National Taipei University of Nursing and Health Sciences
Collaborators: Bach Mai Hospital
Conditions: Hemodialysis
Interventions: Yoga-resistance exercise
Locations: Bach Mai Hospital
Countries: Vietnam
Enrollment: 65
Age range: 45 Years - 65 Years
Sex: ALL

Summary:
Objective: Intra-dialytic exercises are strongly believed to have benefits and have become a crucial therapeutic modality for managing hemodialysis patients. The effects of each type of exercise and yoga on hemodialysis patients' physical and psychological health have been studied extensively. However, the effects of combining yoga and resistance training exercises remain unclear in this population. The aims of this study are: (1) to create a feasible intradialytic yoga-resistance exercise (YRE) program for hemodialysis patients; and (2) to investigate its effects on muscle strength, fatigue, depression, and sleep quality in hemodialysis patients.

Methods: Seventy-two participants will be randomly assigned to a 12-week YRE group or a wait-list control group. The YRE group will perform exercises (breathing exercises, flexibility, resistance exercises, relaxation with meditation) in the first two hours of each hemodialysis session, three times weekly. The outcome measures are the following: socio-demographic characteristics; fatigue (measured by the Functional Assessment of Chronic Illness Therapy-Fatigue); depression (the Patient Health Questionnaire); sleep quality (Pittsburgh Sleep Quality Index); muscle strength (a hydraulic hand dynamometer, hand-held dynamometer, and one-minute sit-to-stand test). The outcomes will be assessed at baseline, week 6, and week 12. The independent t-test will be applied to compare the differences in outcome scores between groups at different time points. Using a generalized estimating equation method to analyze the effects of the intervention on the outcome variables.

Results: The expected results are: (1) The combined YRE program is feasible and safe for hemodialysis patients. (2) After 12 weeks, the intervention group will show significant improvement in muscle strength, fatigue, depression, and sleep quality compared to the control group.

Eligibility criteria:
Inclusion Criteria:

* Diagnosed with ESRD
* Undergoing maintenance hemodialysis treatment for more than three months,
* Age between 45 years and 65 years old,
* Under the permission of their nephrologist,
* Able to communicate in Vietnamese.

Exclusion Criteria:

* Unstable cardiac status such as angina, heart failure stage ≥ 3, myocardial infarction in the last six months, uncontrolled arrhythmia, uncontrolled hypertension with systolic blood pressure ≥ 200 mmHg or diastolic blood pressure ≥ 120 mmHg, symptomatic tachyarrhythmia or bradyarrhythmias, cardiovascular stent implantation, pacemaker installation,
* Artificial joint replacement; amputations or prostheses in upper and lower extremities,
* Suspected or known dissecting aneurysm,
* Uncontrolled diabetes (blood sugar 2 hours after eating \< 7 or \> 14 mmol),
* Hospitalization during the previous month, except for vascular access repair,
* Currently or in previous month (≥ three times/week) involved in any exercise program (e.g. yoga, aerobic, taichi…),
* Arteriovenous fistula dysfunction or new central venous catheter/ arteriovenous fistula access (less than 3 months)
* Severe cognitive impairment (screened by the nephrologist)
* Currently taking an antidepressant

Outcomes:
Muscle strength- "change" is being assessed