ACTRN12620000408987.

Study name	Structured exercise prograM to reduce Fatigue In patients receiving dialysis: a preference‐stratified adaptive Trial (M‐FIT)
Methods	Study design RCT Duration of follow‐up: 36 weeks (12 weeks treatment + additional 24 weeks follow‐up)
Participants	Study characteristics Country: Australia Setting: multicentre Inclusion criteria On maintenance HD or PD (> 3 months) with a life expectancy of > 12 months ≥ 18 years Willing to participate and provide informed consent Able to speak, read and write English Access to a smartphone or tablet with Internet access Ability to carry out movements at intensity level 1 of all 3 exercise prescriptions and the stretches in the control arm (as assessed by the site exercise professional) Exclusion criteria Known cardiovascular disease that places the participant at an unacceptable risk of untoward events occurring during exercise training (as deemed by the treating physician) Have received or are expected to receive a kidney transplant within 12 months Currently meeting the physical activity guidelines as assessed by Active Australia Survey/National Health survey (150 min/week of moderate‐intensity aerobic (cardio) activity and 2 sessions/week of resistance training)
Interventions	Intervention group 1 Walking (3 non‐consecutive days/week, (~60 min/session); will complete a series of stretches after their walking sessions) Intervention group 2 Resistance training (3 non‐consecutive days/week (~60 min/session); consists of a core set of 8 exercises, option to include 2 exercises to facilitate individualisation of exercise prescription, includes warm‐up and cool‐down stretches. e.g. sit to stand, wall push up, standing horizontal TheraBand row, etc) Intervention group 3 Combination of aerobic (cardio) and resistance training (3 non‐consecutive days/week (~60 minutes/session); e.g. aerobic/cardio: walking, cycling etc e.g. resistance: sit to stand, wall push ups etc, which are home‐based exercises delivered through a mobile application) Control group Same process as the exercise arms; however, access on the M‐FIT application will be restricted to a low‐intensity stretching routine only (no access to exercise sessions or videos). They will be doing 3 non‐consecutive days of stretches e.g. shoulder stretch, hip flexor stretch etc for about 10 mins at home, via the app and complete trial outcome assessment questionnaires Co‐interventions Not reported
Outcomes	Planned outcomes Fatigue Pittsburgh Fatigability Scale questionnaires: baseline, 4, 8, 12, 36 weeks FACIT‐Fatigue: SONG‐HD Fatigue: baseline, 4, 8, 12, 36 weeks FACIT Fatigue Scale: baseline, 4, 8, 12 weeks Physical activity Wrist‐worn activity monitor (ActiGraph): baseline, at week 12 and week 36 Neuromuscular fitness: baseline, at week 12 and week 36 Heart rate: at week 12 and week 36 Death Vascular access: up to 36 weeks PD infections: up to 36 weeks Technique survival: up to 36 weeks Exercise adherence Study‐specific self‐report questionnaires to be completed for every exercise session: up to 12 weeks Hospitalisation: up to 36 weeks HRQoL EQ‐5D‐5: baseline, 4, 8, 12, 36 weeks Cost‐effectiveness and cost‐utility: up to 36 weeks Frailty Fried Frailty Index: baseline, at week 12 and week 36 Mood HADS: baseline, 4, 8, 12, 36 weeks Social participation Ability to Participate in Social Roles and Activities (PROMIS‐SF) questionnaire: baseline, 4, 8, 12, 36 weeks BMI: baseline, 12, 36 weeks Exercise capacity 6MWT: baseline, 12, 36 weeks Balance Tinetti balance test (score): baseline, 12, 36 weeks Sleep Wrist‐worn activity monitor (ActiGraph): baseline, at week 12 and week 36 Process evaluation (for patients and staff) Qualitative semi‐structured interviews: immediately post‐intervention and another 12 months post‐intervention Usability of the M‐FIT mobile application Modified system usability scale (mSUS): at week 36
Starting date	March 2020
Contact information	Allison Jaure Phone: +61 2 9845 1467 Email: allison.jaure@sydney.edu.au
Notes	ClinicalTrials.gov Identifier: ACTRN12620000408987. Funding: Australian Department of Health. Recruitment status: Not yet recruiting