Rehabilitation after bone marrow transplant- what is the impact on patient outcomes? The REBOOT trial
The impact of Rehabilitation after bone marrow transplant on physical function outcomes. The REBOOT trial
University of Melbourne
170 participants
Dec 1, 2022
Interventional
Conditions
Summary
This research will be conducted at four Australian hospitals. This study aims to investigate the effectiveness of an eight-week multidisciplinary rehabilitation intervention (including exercise and nutrition) i in patients 30 days following bone marrow transplant (either from a donor or from yourself), compared to usual care. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have received a bone marrow transplant within the last 30 days and you are able to walk independently. or using a gait aid Study details All participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to either the intervention program or usual care. Participants who are allocated to the intervention program will firstly undergo a one-on-one session with a dietitian to review their current diet and discuss options to optimise their intake to meet their needs and have their function measured by a Physiotherapist. They will then undertake an 8- week exercise program that will be delivered via telehealth as 2 x 1 hour sessions each week with a face to face session in week 4 replacing one telehealth session. At the end of the program, all participants will be asked to attend a follow-up session to measure their fitness, nutrition, healthcare utilisation and and quality of life. Participants will also be asked to provide these details again at 6 and 12 months after completion of the program/usual care to determine any long term effects. It is hoped this research will demonstrate that delivery of an individualised nutrition and exercise program to patients who have undergone a bone marrow transplant will lead to improvements in their physical function and quality of life.
Eligibility
Plain Language Summary
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Interventions
The delivery model will be predominately via telehealth consultations but include 2 face to face sessions (at baseline and at approximately 4 weeks) to perform baseline measures, teach use of accelerometer and at week 4 to assess that exercises are being performed optimally. Intervention will commence at the next available session after recruitment (at 30 days +/- 10 working days) but within 2 weeks of recruitment. Delivery of all sessions will be underpinned by behaviour change principles in order to promote adherence to both exercise and nutritional advice and the longer-term maintenance of exercise and a healthy diet. Instructors will be trained by a behaviour change scientist in how to promote goal setting, intrinsic motivation, self-efficacy and habit formation (i.e., key determinants of sustained behaviour change). In addition behaviour change strategies will include action planning, barrier identification/problem solving, self-monitoring of behavioural outcomes (using an activity monitor and diary), relapse prevention/coping planning and providing feedback regarding performance. Participants will be provided with comprehensive and evidence-based behaviour change resources to support self-management. These will be developed specifically for this study. Prior to commencement of the exercise program, intervention participants will attend an individual 60minute session with the trial dietitian (telehealth or face to face). During this session, a comprehensive nutrition assessment will be completed in order to inform individualised dietary advice to achieve a protein intake of 1.5g/kg body weight, and 25 to 30 kcal/kg/body weight aimed at optimising lean mass and preventing increase in fat mass. While a food-based approach will be utilised, participants will also be instructed to take a powdered whey-based protein supplement (20g protein) taken within 30 minutes of exercise, added to a liquid of their choice to preserve and build muscle mass. Individualised dietary advice will also be provided to modify aspects of participants dietary intake and eating patterns to minimise long-term treatment-related cardiometabolic consequences. Exercise sessions (60-75 minutes), supervised by a physiotherapist, will be conducted twice weekly for eight-weeks. Remote sessions will be delivered using the telehealth platforms available within the hospital recruitment sites. Exercise via telehealth will include warm up and cool down exercises, interval training for 30 mins and resistance training for 20 minutes. Heart rate and/or BORG RPE will guide exercise intensity (aiming for a moderate-high intensity 4-6/10) and exercise progressed according to current exercise guidelines. Aerobic Exercises via telehealth will include for example, marching on the spot, running on the spot, star jumps, marching with concurrent upper limb exercises. Exercise and rest intervals will be set depending on the initial patient assessment. Resistance exercises will include functional exercises such as sit to stand, heel-raises, squats, step ups, bench push ups, bicep curls, overhead press, shoulder abduction. Resistance exercises will be prescribed from baseline assessment findings (10 repetition maximum) and commenced at 80% of this. Participants will be reminded about diet and whey protein supplementation at each session and adherence will be recorded by the physiotherapist. There will be rolling recruitment to the trial with exercise sessions group based where possible with up to 4 participants. A home program of moderate level continuous exercise (walking) will be prescribed aiming to exercise on the days not attending group sessions on telehealth. This program will be individualised but aim for walking 30 mins per session, 3-5 days per week. Exercise prescription will follow the Frequency, Intensity, Time and Type (F.I.T.T.) training from baseline assessment findings (e.g., six-minute walk test or BORG RPE). Wearable devices will be provided to participants to track their physical activity levels (step count and activity levels) during the trial. A fidelity check list designed specifically, will used to measure exercise intensity, frequency and mode after every exercise session. Feasibility data will be collected (eg number of sessions attended) as per process evaluation outcome measures. At one centre prehabilitation is already usual care. This centre undertakes autologous bone marrow transplant (BMT). Prehabilitation will be provided according to their protocols in the 4-6 weeks prior to BMT. Prehabilitation includes exercise sessions twice weekly until transplant (aerobic and resistance similar to the exercises described above) with design based upon individual assessments and using telehealth or face to face as individual or group sessions and may include dietary advice. These sessions (as part of usual care) will be documented. At this same centre we will also measure consecutive participant ultrasound muscle mass and quality of rectus femoris thigh muscle at baseline and follow up one (week 9 after rehabilitation program).
Locations(3)
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ACTRN12622001071718