None listed
Conditions
Brief summary
Fatigue is one of the most common and debilitating symptoms in patients on dialysis and with advanced chronic kidney disease (CKD stage 5.) The prevalence of fatigue ranges from 55% to as high as 97% in adult patients on dialysis and is associated with impaired quality of life and increased mortality. Fatigue is also consistently ranked as critically important by patient on dialysis, even higher than death. Our global Standardised Outcomes in Nephrology (SONG) initiative, involving over 2000 patients receiving dialysis, caregivers, and health professionals across 100 countries, established fatigue as a critically important core outcome. Lifestyle (including exercise) interventions was the top priority identified through the research priority setting partnership. Evidence for exercise interventions remains very uncertain due to factors such as the plethora of measurements used to assess fatigue and small sample size. A patient workshop was convened to identify and prioritise exercise interventions for the M-FIT study to ensure acceptability and feasibility. M-FIT is a multi-centre, adaptive randomised comparative effectiveness trial of three structured exercise programs and a control in patients with kidney failure. The primary outcome of this trial is fatigue as measured by FACIT-Fatigue at 12 weeks. Secondary outcomes include additional measures of fatigue, quality of life, mood, life participation, body composition, exercise capacity, neuromuscular fitness, balance, physical activity, sleep, exercise adherence, SONG core outcomes, hospital admissions, cost-effectiveness, app usability, preference and safety.
Interventions
The trial consists of three different exercise prescriptions arms namely A) walking (3 non-consecutive days/wk, (~60 mins per session); will complete a series of stretches after their walking sessions) , B) resistance training (3 non-consecutive days/wk (~60 mins per session); consists of a core set of 8 exercises, option to include 2 exercises to facilitate individualisation of exercise prescription, includes warm-up and cooldown stretches. e.g. Sit to stand, wall push up, standing horizontal
The trial consists of three different exercise prescriptions arms namely A) walking (3 non-consecutive days/wk, (~60 mins per session); will complete a series of stretches after their walking sessions) , B) resistance training (3 non-consecutive days/wk (~60 mins per session); consists of a core set of 8 exercises, option to include 2 exercises to facilitate individualisation of exercise prescription, includes warm-up and cooldown stretches. e.g. Sit to stand, wall push up, standing horizontal TheraBand row, etc C) a combination of aerobic (cardio) and resistance training (3 non-consecutive days/wk (~60 mins per session); e.g. aerobic/cardio: walking, cycling etc e.g. resistance: sit to stand, wall push up etc which are home-based exercises delivered through a mobile application. a)Participants will have an initial assessment with the exercise professional during which they will be assigned a suitable exercise intensity level and have a demonstration of the exercises they need to perform. They will be provided with the M-FIT mobile application and instructions by the research team. b)The mobile application gives the participant access to exercise videos applicable to their allocated group, and trial outcome assessment questionnaires (fatigue, quality of life, exercise adherence etc.). c) Each group will be scheduled to perform three (3) sessions of exercise per week for 12 weeks. The duration of the exercise sessions will be determined by the results of their initial exercise assessment by exercise professional but will be no more than one (1) hour. Duration of the intervention period is 12 weeks. c) Participants will have regular telehealth check up sessions with the exercise professional (week 1, 2, 3, 4, 6 and 8) and possible adjustment of the intensity level based on clinical and personal factors to ensure appropriate exercise intensity. At week 12 and week 36, participants will have physical assessments with the exercise professional. d) Physical activity/sleep will be measured using a wrist-worn activity monitor (ActiGraph) 7 complete days before starting the intervention and 7 complete days after the intervention (at week 12 and week 36) and using a Fitbit tracker given to the participants.
Sponsors
University of Sydney
University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients on maintenance haemodialysis or peritoneal dialysis (>3 months) with a life expectancy of >12 months. 2. Age >= 18 years 3. Able to provide informed consent 4. Able to speak, read and write English 5. Have access to a smart phone or tablet with internet access 6. Ability to walk continuously for 2 minutes (use of a prosthesis or wheely walker is permitted)
Exclusion criteria
1. Presence of known cardiovascular disease that places the participant at an unacceptable risk of untoward event occurring during exercise training (as deemed by treating physician) 2. Have received or are expected to receive a kidney transplant within 12 months 3. Currently meeting the physical activity guidelines^ ^ 150 mins/week of moderate intensity aerobic (cardio) activity which includes 2 sessions/week of resistance training
Outcome results
None listed