Intradialytic Yoga-resistance Exercise for Hemodialysis Patients

NCT05535114 | Completed

• 1 other identifier: 2431/BM-HĐĐĐ
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hemodialysis

Keywords

intra-dialytic yoga-resistance exercise; hemodialysis; muscle strength; fatigue; sleep quality; depression; body composition

Outcome Measures

Primary Outcomes (1)

• Muscle strength- "change" is being assessed

  Handgrip strength will be measured by a dynamometer (NY 10602 USA). The test-retest reliability of this equipment was confirmed in a previous study (Savva et al., 2014). Extension/flexion of elbow, shoulder, and hip; and hip abduction/adduction will be assessed by the handheld dynamometer (USA, model 01163). Validity and reliability of a handheld dynamometer in measuring upper limb strength have been confirmed (Chen et al., 2021). We use the testing protocol reported from a prior study (Andrews et al., 1996). One-minute STS test: It is a valid and reliable measures of lower limb muscle strength (Segura-Ortí \& Martínez-Olmos, 2011). The number of repetitions of sitting down and getting up from a chair in one minute will be recorded.

  Pre-test (before intervention start); Post-test one (at week 6); Post-test two (at week 12)

Secondary Outcomes (6)

• The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)

  Pre-test (before intervention start); Post-test one (at week 6); Post-test two (at week 12)

• Patient Health Questionnaire (PHQ-9)

  Pre-test (before intervention start); Post-test one (at week 6); Post-test two (at week 12)

• The Pittsburgh Sleep Quality Index (PSQI)- "change" is being assessed

  Pre-test (before intervention start); Post-test one (at week 6); Post-test two (at week 12)

• Body composition

  Pre-test (before intervention start); Post-test one (at week 6); Post-test two (at week 12)

• International Physical Activity Questionnaire short version (IPAQ-SF)

  Pre-test (before intervention start); Post-test one (at week 6); Post-test two (at week 12)

Study Arms (2)

Yoga-resistance exercise (YRE) group

EXPERIMENTAL

The YRE group will perform breathing exercises, flexibility, resistance exercises and relaxation. It will be carried out for about 30 to 45 minutes in the first two hours of each hemodialysis session, three times weekly for 12 weeks. The intensity of resistance exercise will be adjusted individually at week 3, week 7, and week 11 to the rate of perceived exertion of "somewhat hard" (on the Borg scale 6-20). The intensity of resistance exercise will be increased gradually by changing the different colors of elastic bands.

Other: Yoga-resistance exercise

Control group

NO INTERVENTION

Participants in the control group will receive only usual care. They will be able to receive the YRE protocol after completing the study.

Interventions

Yoga-resistance exercise OTHER

Breathing exercise (5 minutes), flexibility (5 minutes), resistance exercise (20 minutes), relaxation \& meditation (10 minutes).

Yoga-resistance exercise (YRE) group

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taipei University of Nursing and Health Sciences: lead
• Bach Mai Hospital: collaborator

Study Sites (1)

Bach Mai Hospital

Hanoi, 1000000, Vietnam

Location

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MeSH Terms

Conditions

Fatigue; Sleep Initiation and Maintenance Disorders; Depression

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 10, 2022
• Study Start: July 13, 2023
• Primary Completion: October 13, 2023
• Study Completion: October 15, 2023
• Last Updated: November 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)