None listed
Conditions
Brief summary
This study will be a two-group parallel design randomised controlled trial (RCT). The primary aim of this study is to evaluate the effectiveness of practicing yoga during haemodialysis (HD) (i.e. intradialytic yoga) for improving fatigue, physiological and psychological health outcomes in patients with end stage kidney disease (ESKD) receiving treatment in hospital or satellite dialysis facility settings. We hypothesise that patients with ESKD who practice intradialytic yoga for 3 sessions per week over a 12-week period will experience a 23% reduction in symptoms of fatigue by the end of the RCT period compared with usual care alone. We also hypothesise that intradialytic yoga will be associated with: reduced symptoms of post dialysis fatigue; improved quality of life; improved patient engagement in dialysis therapy plans including self care, self-management and adherence; and changes in biochemistry. Data will also be collected on participants’ beliefs about the treatment intervention, the recruitment rate, drop out rate, adherence to the intervention and safety. Participants will be recruited from 2 dialysis facilities in Brisbane Queensland via posters, flyers and site visits by the Chief Investigator. Participation will involve attending an initial intake session during routine dialysis treatment time, followed by being randomly allocated to: 1) intradialytic yoga; or 2) usual care alone. Participants will be asked to provide consent to access confidential data recorded in medical records including medical and renal health history such as blood test results, body weight measurements and routine HD observations such as blood pressure. Participants will also be asked to complete a number of questionnaires and a post dialysis fatigue diary. These will be given at: 1) the start of the study; 2) half way (at 6 weeks); and 3) at the end of the study (week 12). Data collected from medical records and questionnaires will enable the research team to evaluate the effectiveness of the intervention for the needs of ESKD patients. Following the intervention period, participants in the intradialytic yoga group will be invited to participate in an interview to enquire about their experiences of yoga during the study.
Interventions
The study intervention will be group yoga sessions conducted during routine haemodialysis (HD) treatment (i.e. intradialytic yoga) 3 times per week at 2 dialysis clinics in Brisbane Queensland. Participants randomised to the intervention group will also continue to maintain their current treatment, health and lifestyle practices.
The intradialytic yoga protocol is based on a therapeutic style of yoga known as 'Viniyoga' and has been designed to enable HD patients of various age groups, health
The study intervention will be group yoga sessions conducted during routine haemodialysis (HD) treatment (i.e. intradialytic yoga) 3 times per week at 2 dialysis clinics in Brisbane Queensland. Participants randomised to the intervention group will also continue to maintain their current treatment, health and lifestyle practices. The intradialytic yoga protocol is based on a therapeutic style of yoga known as 'Viniyoga' and has been designed to enable HD patients of various age groups, health conditions and comorbidities to participate. Group yoga sessions will commence during the first hour of treatment, immediately after the participant has been connected to the dialysis machine, is comfortable and stable. Sessions will involve a series of gentle movements, stretching, breathing exercises, relaxation techniques and meditation while comfortably seated in a dialysis chair. Yoga practices will be tailored to the individual needs of the group. To ensure the safety and comfort of participants and to reduce the risk of injury, the Chief Investigator will offer participants modifications including alternative postures, and physical adjustments when needed. Participants will also be strongly encouraged to practice at their own level based on how well they feel at each session. The intervention period is 12 weeks. The duration of yoga sessions will progressively increase in length commencing at 15 minutes per session, and will gradually increase by 10 minutes per session every 3 weeks building up to 45 minutes by the end of the study. The Chief Investigator who is a qualified yoga teacher will facilitate all group yoga sessions in the study. This will maintain fidelity in delivery of the intervention throughout the study ensuring the sequences and primary features of the intervention will be consistently delivered as proposed in the protocol. Adherence will also continuously be monitored and documented throughout the study. This will be measured as the frequency and duration (in minutes) of participation per session, and qualitative feedback from participants.
Sponsors
Ms Kylie Barr
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Patients who have been receiving routine haemodialysis (HD) for a period of greater than 90 days prior to trial entry; In-centre patients with a HD prescription of 3 treatment sessions per week; Patients with an arterial venous fistula or graft; Patients who are ‘haemodynamically stable’ meaning no medical intervention has been needed for hypotensive episodes and use of saline at least 2 weeks prior to trial entry; Receive a global fatigue score of -4 on the Brief Fatigue Inventory scale; Must be competent to understand the research procedures, and provide written informed consent; and Not currently practicing yoga.
Exclusion criteria
ESKD patients who dialyse at home; ESKD patients who are treated with peritoneal dialysis; haemodialyis (HD) patients with catheters, including cuffed tunneled and non-cuffed non-tunneled catheters; and HD patients with concomitant conditions that in the opinion of the Chief Investigator may adversely affect the safety and efficacy of the intradialytic yoga intervention, or severely limit the patient’s ability to complete the study.
Outcome results
None listed