Structured exercise program to reduce fatigue in patients with kidney failure: an adaptive trial (M-FIT)
Principal Investigators: Professor Allison Jaure
Clinical Project Manager: Peta-Anne Paul-Brent
Clinical Research Associate: Sanket Vakil and Aparna Shenoy
Trial Number: AKTN 20.02
ANZCTR registration: M-FIT page
Population: Adults aged over 18 years with advanced chronic kidney disease (CKD stage 5) with an estimated eGFR <15ml/min/1.7m2 (>3 months).
Intervention: Structured exercise program vs control (stretching)
Follow-up: 12 weeks
Primary outcome: Fatigue (FACIT-F) at 12 weeks
Status: Open to recruitment
Target Recruitment: 150 participants from Australia and New Zealand
Trial Infographic:
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 and those who have CKD (stage 5).
M-FIT is an adaptive, multi-centre, randomised trial looking at the comparative effectiveness of structured exercise program versus control (stretching) on fatigue in patients with kidney failure. The exercise program is 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, HD transfer, death; b) patient reported outcomes mainly quality of life, intervention adherence; c) exercise physiologist assessed outcomes mainly neuromuscular fitness, exercise capacity, body composition, frailty; d) economic outcomes mainly health-care utilisation and cost.
The study has already received funding from the Medical Research Future Fund Rare Cancers, Rare Diseases and Unmet Need Initiative.