The Effects of an Intradialytic Yoga-Resistance Exercise on Muscle Strength, Fatigue, Depression, and Sleep Quality in Hemodialysis Patients: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Muscle strength- "change" is being assessed
研究概览
简要总结
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.
详细描述
Study design: a randomized controlled trial.
Setting: This study will be conducted at the dialysis department of the Bach Mai hospital which is a national-level hospital in Hanoi, Vietnam.
Sample size: The sample size was calculated using G*Power software 3.1.9.7 (Faul et al., 2007) with α = 0.05, the 1-beta error probability of 0.80, and the effect size for the main outcome of the leg muscle strength was 0.66 (Rosa et al., 2018). A sample size of 30 participants for each group was calculated. Anticipating a 20% attrition rate, a total number of 36 participants is assigned to each group.
Recruitment process: The potentially eligible participants will be referred by the head nurse or the nephrologists at the Dialysis Department of Bach Mai hospital. The researcher will assess the potential participants' eligibility via their medical records and cognitive and physical function assessment as well as reconfirm with their nephrologists. The researcher will explain the study's purpose, procedures, potential benefits, and risks of participating in this study to patients and their families.
Randomization & allocation concealment: The randomization procedure will be performed by a nurse lecturer who does not participate in the study recruitment and data collection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Muscle strength- "change" is being assessed
时间窗: Pre-test (before intervention start); Post-test one (at week 6); Post-test two (at week 12)
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.
次要结局
- 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))
- 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))
- 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))
- The 5-item healthy eating score (HSE)(Pre-test (before intervention start); Post-test one (at week 6); Post-test two (at week 12))
研究者
Tsae Jyy, Wang
Professor
National Taipei University of Nursing and Health Sciences