Structured exercise program to reduce fatigue in patients receiving dialysis: an adaptive trial (M-FIT)
Principal Investigators: Professor Allison Jaure
Clinical Project Manager: Peta-Anne Paul-Brent
Clinical Research Associate: Aparna Shenoy
Trial Number: AKTN 20.02
Population: Adults aged over 18 years with kidney failure receiving haemodialysis or peritoneal dialysis for more than three months
Intervention: Three structured exercise programs vs control (stretching)
Follow-up: 24 weeks
Primary outcome: Fatigue (FACIT-F) at 12 weeks
Status: Recruitment to commence Q3 2023
Target Recruitment: 400 participants from Australia and New Zealand
Trial Summary:
Kidney failure is growing public health problem worldwide and is fatal unless treated with dialysis or transplantation. Fatigue affects up to 97% of patients receiving dialysis and is an important patient-reported outcome. While there is some data to suggest that exercise may improve fatigue, certainty of evidence is low. Many clinical trials of exercise in patients undergoing dialysis concentrate on either physical outcomes or exercise during dialysis sessions. There is an urgent need for trials examining the role of exercise on fatigue in patients undergoing dialysis.
M-FIT is an adaptive, multi-centre, randomised trial looking at the comparative effectiveness of three structured exercise program versus control (stretching) on fatigue in patients receiving dialysis. The exercise programs are administered through a bespoke mobile application.
The primary outcome will be participants rating of fatigue at 12 weeks. Secondary outcomes include a) clinical outcomes mainly cardiovascular disease, vascular access function, technique survival, PD infections, physical activity, sleep, death; b) patient reported outcomes mainly quality of life, additional measures of fatigue, intervention adherence, life participation, mood; c) exercise physiologist assessed outcomes mainly neuromuscular fitness, exercise capacity, body composition, frailty; d) economic outcomes mainly health-care utilisation and cost; and e) Application usability.
The study has already received funding from the Medical Research Future Fund Rare Cancers, Rare Diseases and Unmet Need Initiative.