None listed
Conditions
Brief summary
This study will determine the effect of highly targeted exercise on the bone health of people with multiple myeloma. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with multiple myeloma and you are currently taking bisphosphonates (bone active medication). Study details Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to one of two groups. Participants allocated to the first group will be given an individual exercise program that consists of two supervised sessions and one at-home session per week. Participants in this group will be asked to complete these weekly sessions for 9 months. Participants allocated to the second group will be asked to continue with their current care program which may include exercise but will not include the weekly program described above. Participants in the second group will also be given information sheets to review from Myeloma Australia. All participants will be asked to undergo a series of assessments, including bone scans and exercise assessments at 3-months and 9-months after enrolment. It is hoped this research will demonstrate that bone-targeted exercise will not only maintain bone health but may delay the progression of bone tumours by altering the behaviour of bone cells. It is also hoped that this exercise program can increase muscle strength and physical function, and reduce pain, improving quality of life in people with multiple myeloma.
Interventions
A structured, supervised, and individualised 9-month exercise program, three times per week for one hour in duration.
Participants will be supervised by an accredited exercise physiologist (AEP) for two sessions per week, either individually or in groups of up to 5 participants, in hospital, university or private gyms. In addition, one self-managed unsupervised exercise session per week will be prescribed. The AEP will individually tailor exercises for all participants, with consideration of ne
A structured, supervised, and individualised 9-month exercise program, three times per week for one hour in duration. Participants will be supervised by an accredited exercise physiologist (AEP) for two sessions per week, either individually or in groups of up to 5 participants, in hospital, university or private gyms. In addition, one self-managed unsupervised exercise session per week will be prescribed. The AEP will individually tailor exercises for all participants, with consideration of neutropenic risks, lytic lesions, and spinal instability. A multi-modal program of bone-targeted high-intensity resistance training (using free and machine weights and therabands), impact loading (using steps and hurdles), and aerobic exercise training (using stationary cycles and treadmills) will be prescribed. Attendance will be monitored using a session log and by the participant using self-reporting exercise diaries. Exercise adherence at the in-person sessions will be monitored by the AEP using heart rate monitors, and session checklists for progression, intensity (Borg 6-20 and OMNI-RES 0-10 RPE scales), numbers of sets or impacts, and repetitions. Aerobic training will commence at low-intensity (9–10 Borg RPE), with 2 bouts at high-intensity (16-19 Borg RPE), interspersed by recovery (12-15 Borg RPE). Resistance exercises will commence at a low intensity, gradually progressing in intensity to high (6-9 OMNI-RES) throughout the intervention, guided by participant responses.
Sponsors
University of Technology Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
i. Diagnosis of multiple myeloma; ii. Aged greater than or equal to 18 years; iii. Performance status 0–2, as per Eastern Cooperative Oncology Group scoring system (ECOG) iv. Currently taking bisphosphonates.
Exclusion criteria
i. Undertaking similar exercise to the intervention; ii. Deemed unsafe to participate in exercise by their treating doctor; iii. Cognitive impairment that impedes the ability to complete questionnaires.
Outcome results
None listed