Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000408987
Ethics application status
Approved
Date submitted
20/02/2020
Date registered
26/03/2020
Date last updated
10/04/2024
Date data sharing statement initially provided
26/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Structured exercise prograM to reduce fatigue In patients receiving dialysis: an adaptive Trial (M-FIT)
Scientific title
Structured exercise prograM to reduce fatigue In patients receiving dialysis: an adaptive Trial (M-FIT)
Secondary ID [1] 297651 0
None
Universal Trial Number (UTN)
Trial acronym
M-FIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney Failure 313143 0
dialysis 313144 0
Condition category
Condition code
Renal and Urogenital 311618 311618 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.

Intervention code [1] 314673 0
Treatment: Other
Comparator / control treatment
Participants in the control group will complete the 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. Participants in the control group will receive the same amount of interaction time with trial staff as the exercise arms to ensure equipoise.
Control group
Active

Outcomes
Primary outcome [1] 320316 0
Fatigue as measured by Functional Assessment Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionnaire
Timepoint [1] 320316 0
12 weeks after intervention commencement
Secondary outcome [1] 371226 0
Mortality
Timepoint [1] 371226 0
Up to 36 weeks after intervention commencement
Secondary outcome [2] 380562 0
Fatigue as measured using FACIT-Fatigue and tools alternative to FACIT-Fatigue and Standard Outcomes in Nephrology-Haemodialysis Fatigue (SONG-HD Fatigue).
Timepoint [2] 380562 0
Baseline, 4, 8, 12 and 36 weeks after intervention commencement
Secondary outcome [3] 380563 0
Vascular access function (for HD patients only) measured by rate of intervention obtained from regular AESI/SAE reporting.
Timepoint [3] 380563 0
Up to 36 weeks after intervention commencement
Secondary outcome [4] 380564 0
PD Peritonitis and HD transfer (for PD patients only) obtained from ANZDATA and SAE reporting.
Timepoint [4] 380564 0
Up to 36 weeks after intervention commencement
Secondary outcome [5] 380565 0
Exercise adherence measured by study-specific self report questionnaire to be completed following each exercise session:
Timepoint [5] 380565 0
Up to 12 weeks after intervention commencement
Secondary outcome [6] 380566 0
Hospital admissions measured by number of hospital admissions and length of stay in days via hospital admission data and data linkage.
Timepoint [6] 380566 0
Up to 36 weeks after intervention commencement
Secondary outcome [7] 380567 0
Health-related quality of life measured by patient reported outcome measure: EQ-5D-5L questionnaire
Timepoint [7] 380567 0
Baseline, 4, 8, 12 and 36 weeks after intervention commencement
Secondary outcome [8] 380568 0
Cost-effectiveness and cost utility analysis will be assessed by using data linkage to MBS, PBS, Hospital admitted and non-admitted events and ANZDATA.
Timepoint [8] 380568 0
Up to 36 weeks after intervention commencement
Secondary outcome [9] 380569 0
Physical activity (in minutes) will be measured using an ActiGraph GT9X Link wrist accelerometer (wrist worn activity monitor)
Timepoint [9] 380569 0
Baseline (7 complete days prior to the intervention), week 12 (7 complete days prior to intervention end) and week 36 (7 complete days prior to the follow-up visit)
Secondary outcome [10] 380570 0
Neuromuscular fitness measured by Modified wall push-up test (number), 30 second sit to stand (number), timed up and go (time), hand grip strength test (kg)
Timepoint [10] 380570 0
Baseline, 12 and 36 weeks after intervention commencement
Secondary outcome [11] 380572 0
Frailty measured by the Fried Frailty Index assessed at the sessions with exercise professional. The five criteria for this assessment are weight loss, exhaustion, physical activity, slowness, and weakness. The sum of scores in these categories classifies individuals into three frailty conditions: not frail, pre-frail and frail.
Timepoint [11] 380572 0
Baseline, 12 and 36 weeks after intervention commencement
Secondary outcome [12] 409784 0
Mood measured by patient reported outcome measure: Hospital Anxiety and Depression Scale (HADS)
Timepoint [12] 409784 0
Baseline, 12 and 36 weeks after intervention commencement
Secondary outcome [13] 409785 0
Life participation measured by patient reported outcome measure: PROMIS-SF (Ability to Participate in Social Roles and Activities) questionnaire
Timepoint [13] 409785 0
Baseline, 4,8,12, and 36 weeks after intervention commencement
Secondary outcome [14] 409786 0
Body composition measured by Body mass index (BMI: calculated as ratio of the weight of the body in kilograms to the square of its height in meters) and Waist circumference (in cm).
Weight of the body measured by digital scales, height and waist circumference measured by tape measure.
Timepoint [14] 409786 0
Baseline, 12 and 36 weeks after intervention commencement
Secondary outcome [15] 409787 0
Exercise capacity measured by Six-minute walk test (metres) and Two-minute step test to assess aerobic endurance and functional fitness assessed at the sessions with exercise professional.
Timepoint [15] 409787 0
Baseline, 12 and 36 weeks after intervention commencement
Secondary outcome [16] 409788 0
Balance measured by Tinetti balance test (score) assessed at the sessions with exercise professional. This series of tests assesses patients balance and coordination and is an indicator of falls risk.
Timepoint [16] 409788 0
Baseline, 12 and 36 weeks after intervention commencement
Secondary outcome [17] 409789 0
Sleep (in min) will be measured using ActiGraph (ActiGraph GT9X Link) wrist accelerometer and Fitbit
Timepoint [17] 409789 0
ActiGraph: Baseline (7 complete days prior to the intervention), week 12 (7 complete days prior to intervention end) and week 36 (7 complete days before the follow-up visit)
Fitbit: Up to 36 weeks after intervention commencement
Secondary outcome [18] 409790 0
Process evaluation: Qualitative semi-structured interviews will be conducted with purposively sampled patients and caregivers (min. n=30) from the three treatment arms.
Timepoint [18] 409790 0
One interview immediately post-intervention and another 24 weeks post-intervention
Secondary outcome [19] 409791 0
The usability of the M-FIT mobile application will be assessed using modified system usability scale (mSUS).
Timepoint [19] 409791 0
Week 36 after intervention commencement
Secondary outcome [20] 409792 0
Participant safety measured using data collected from adverse events of special interest (number and type), serious adverse events (number and type), exercise related injuries (number and type), exercise survey (number and type of issue) and mortality (number). This will be collected using adverse event reporting by the study staff and participant reporting through the app.
Timepoint [20] 409792 0
Up to 36 weeks after intervention commencement
Secondary outcome [21] 409793 0
Process evaluation: Assessment of intervention fidelity across the sites will also be carried out through key-informant interviews of study staff (n=30 interviews with medical, nursing and exercise physiologist’s post-intervention) evaluating potential impact of this on the trial outcomes.
Timepoint [21] 409793 0
One interview post-intervention
Secondary outcome [22] 433860 0
Exercise preference on fatigue measured by study-specific preference assessment questionnaire
Timepoint [22] 433860 0
Secondary outcome [23] 433861 0
Exercise preference on fatigue measured by study-specific preference assessment questionnaire
Timepoint [23] 433861 0
Baseline

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will initially be randomised with equal chance, to 1 of 3 exercise prescriptions or control. The allocation to the control arm will be fixed throughout the trial as a proportion of the number of available arms. At each interim analysis the target allocations to the exercise arms will be updated via response adaptive randomisation, with the probability of allocation to an exercise arm proportional to the relative effectiveness of that exercise arm.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Multi-centre, adaptive, randomised, comparative effectiveness trial of exercise programs and a control in adult patients receiving dialysis (>3 months), using intention-to-treat analyses.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The trial uses a Bayesian adaptive design to compare the 12 week FACIT-Fatigue scores for participants conditional on their treatment allocation. Adaptations include response adaptive randomisation, and arm dropping for harm relative to the control arm with respect to the treatment effect on 12-week FACIT-Fatigue scores.
The primary analysis will target a treatment-policy (intent-to-treat) effect and will be undertaken within a Bayesian framework. The secondary outcomes will be evaluated with an analogous strategy to the primary outcome using longitudinal analyses via mixed models, but ordinal, logistic, and Poisson/Negative Binomial models will replace the linear model for ordinal, binary and count outcomes respectively.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/06/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 22393 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 22394 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 37560 0
2145 - Westmead
Recruitment postcode(s) [2] 37559 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 302180 0
Government body
Name [1] 302180 0
Australian Department of Health, Medical Research Future Fund Medical Research Future Fund Rare Cancers, Rare Diseases and Unmet Need Initiative.
Country [1] 302180 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Edward Ford Building, A27 Fisher Rd, University of Sydney NSW 2006
Country
Australia
Secondary sponsor category [1] 305096 0
None
Name [1] 305096 0
Address [1] 305096 0
Country [1] 305096 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302862 0
Metro South Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 302862 0
Level 7, Translational Research Institute Building
Princess Alexandra Hospital
Ipswich Road, Woolloongabba Qld 4102
Ethics committee country [1] 302862 0
Australia
Date submitted for ethics approval [1] 302862 0
16/09/2021
Approval date [1] 302862 0
23/11/2021
Ethics approval number [1] 302862 0

Summary
Brief summary
Fatigue is one of the most common and debilitating symptoms in patients on dialysis. 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 receiving dialysis.

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91642 0
Prof Allison Jaure
Address 91642 0
Centre for Kidney Research
176 Hawkesbury Road, Westmead NSW 2145
Country 91642 0
Australia
Phone 91642 0
+61 2 9845 1467
Fax 91642 0
Email 91642 0
allison.jaure@sydney.edu.au
Contact person for public queries
Name 91643 0
Aparna Shenoy
Address 91643 0
Australasian Kidney Trials Network
The University of Queensland
Level 5, Translational Research Institute
37 Kent St
Woolloongabba QLD 4102
Country 91643 0
Australia
Phone 91643 0
+61 417 327 331
Fax 91643 0
Email 91643 0
m-fit@uq.edu.au
Contact person for scientific queries
Name 91644 0
Allison Jaure
Address 91644 0
Centre for Kidney Research
176 Hawkesbury Road, Westmead NSW 2145
Country 91644 0
Australia
Phone 91644 0
+61 2 9845 1467
Fax 91644 0
Email 91644 0
allison.jaure@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.