Intradialytic Yoga-resistance Exercise for Hemodialysis Patients
Condition: Hemodialysis
Study type: Interventional

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.
    

Detailed description: 
      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.

      To prevent intervention diffusion, the participants will be randomly assigned to the
      intervention group or the control group according to their hemodialysis (HD) schedules.

      Intervention: The protocol of the combined YRE program will be generated based on findings
      obtained from a literature review. It consists of four parts as follows: breathing exercises,
      flexibility, strength exercises and relaxation. It will be carried out about 30 minutes to 45
      minutes in the first two hours of each HD session after connecting the patient to the
      dialysis machine for 30 minutes, three times weekly for 12 weeks.

      Due to the facility conditions and fall prevention purposes, all types of exercise in the
      combined YRE program will be done when in the supine position.

      The intensity of the resistance training: During the first two weeks of training, the
      participants will perform two sets of 8-12 repetitions for each type of strength exercise
      with the yellow or red elastic band depending on the participant's tolerance. Three sets of
      each exercise will apply from the third week until the end. The rest interval between sets
      and exercises is one to two minutes. The training intensity will be adjusted at week 3, week
      7, and week 11 according to the increase in muscle strength. The intensity of each strength
      exercise will be increased gradually by changing the different colors of elastic bands. The
      intensity of strength exercise that each patient can tolerate will be adjusted to the rate of
      perceived exertion (RPE) of "somewhat hard" (13-14 on the Borg scale) (Borg, 1982).

      Validation of the combined YRE program: This protocol will be validated the suitability by a
      panel of experts before implementing in the feasibility study. The experts include one
      physiotherapist; one nephrologist, one hemodialysis nurse, and one yoga teacher.

      Interventionist: the researcher and another HD nurse (at least five years' experiences
      experience in working with HD patients).

      Intervention delivering: A pre-training information session will be given to all participants
      one week before the intervention at the dialysis unit by the interventionists. The first two
      weeks, participants will be familiarized with the intervention. In the following weeks, the
      participants will practice exercises under the interventionist's supervision.

      Monitor for safety, adverse events: All potentially eligible participants will be confirmed
      by their nephrologists for exercise capacity before recruiting for this study. The blood
      pressure, heart rate, and SpO2 will be monitored before and after training. The
      interventionists will supervise the patient's exercise and monitor for exercise-related side
      effects such as nausea or vomiting; a sudden headache, dizziness, or a feeling of
      lightheadedness; a sudden weakness in your arms or legs; hypotension. Stop exercise and
      medical consultation will be recommended if any of these problems occur. Moreover, other
      side-effects of exercise such as muscle soreness, joint problems, or injuries should also be
      documented.

      Data collection: Data collection will be done at the baseline, week 6, and week 12 on a
      midweek non-dialysis day. The data collector (A nephrology nurse) will be blinded to the
      study group assignment. It takes about 30 minutes.

      Feasibility & Safe of the YRE: The feasibility of the recruitment process, The attrition rate
      The adherence rate, Length of time for intervention implementation, Adverse events associated
      with the intervention.

      Instruments The study questionnaires include questions on demographics (age, gender, marital
      status, education, occupation), The Functional Assessment of Cancer Therapy-Fatigue
      (FACIT-F), Patient Health Questionnaire (PHQ-9), and sleep quality (Pittsburgh Sleep Quality
      Index). Disease characteristics, including body height (cm), weight after dialysis (kg), body
      mass index (BMI, kg/m2), HD vintage (years), HD access site, and Charlson comorbidity index
      will be collected from the participants' medical records. The physical measurements include
      muscle strength measures of upper limbs and lower limbs, and one-minute STS test.

      Data analysis: Using independent t-test and chi-square tests to test the homogeneity of two
      groups at baseline. The independent t-test will be applied to compare the differences on
      outcome's scores between groups in different time points. A generalized estimating equations
      method will be used to analyze the effect of the intervention on the outcome variables.

      Ethical consideration: Ethical approvals will be obtained from the Ethical Committee of Hanoi
      Medical University, Vietnam.
    

Intervention name(s): Yoga-resistance exercise
Intervention type(s): Other
Intervention description(s): Breathing exercise (5 minutes), flexibility (5 minutes), resistance exercise (20 minutes), relaxation & meditation (10 minutes).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: intra-dialytic yoga-resistance exercise; hemodialysis; muscle strength; fatigue; sleep quality; depression; body composition