None listed
Conditions
Brief summary
This study will evaluate the effect of exercise on health-related quality of life, markers of disease progression, bone health, body composition, cardiovascular fitness, physical function and activity behaviours in people with multiple myeloma. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have a diagnosis of multiple myeloma, and are free of any conditions that may prevent safe completion of the exercise demands of the study. Study details Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will immediately commence a 3 stage exercise program. The first stage will be gym-based and involves 2 x supervised sessions and 1 home-based session per week for 12 weeks. All supervised classes will be delivered by an Accredited Exercise Physiologist. Stage 2 is a 12 week home-based program (3 sessions/week) with weekly telephone support, with the option to attend one group-based class each week delivered by an Accredited Exercsie Physiologist. Stage 3 involves a maintenance home-based program for a further 6 months. The program will be individualised to the participants’ cardiorespiratory fitness and bone lesions, and will involve high-intensity aerobic exercise, resistance training and impact loading. Participants in the other group will receive the same program after a 12 week wait, during which time they will receive usual care. All participants will undergo a number of assessments at baseline, 12 weeks, 24 weeks, 36 weeks (group 2 only) 12 months (group 1 only) and 15 months (group 2 only) in order to evaluate health-related quality of life, markers of disease progression, bone health, body composition, cardiovascular fitness, physical function and activity behaviours. The potential findings of this proposed research will ultimately influence the inclusion of exercise as part of standard care to improve the health and longevity of people with multiple myeloma.
Interventions
The intervention will be a structured and individualised 12-week exercise program (Stage 1)
Stage 1: Participants will aim to complete three hour-long exercise sessions per week. For twelve weeks, an accredited exercise physiologist (AEP) will directly supervise two hour-long gym-based sessions per week, either individually or in groups of up to 5 participants. Participants will also be provided with exercise prescription for one session per week as a self-managed home session. The AEP will ind
The intervention will be a structured and individualised 12-week exercise program (Stage 1) Stage 1: Participants will aim to complete three hour-long exercise sessions per week. For twelve weeks, an accredited exercise physiologist (AEP) will directly supervise two hour-long gym-based sessions per week, either individually or in groups of up to 5 participants. Participants will also be provided with exercise prescription for one session per week as a self-managed home session. The AEP will individually tailor exercises for all participants, being cognisant of neutropenic risks, lytic lesions and spinal instability. A multi-modal program of high-intensity aerobic exercise (using cycle ergometers), resistance training (using free and machine weights and therabands) and impact loading (using steps and hurdles) will be prescribed during the intervention, individualised to the participants’ cardiorespiratory fitness and bone lesions and closely monitored by the AEP. Heart rate monitors and the rating of perceived exertion (RPE) will be used to monitor intensity. Exercise maintenance strategies will be utilised to enhance adherence to the home-based exercise program. Stage 1: Twelve weeks gym-based program = 2 x supervised sessions and 1 home-based session per week. All supervised classes will be delivered by an Accredited Exercise Physiologist. Stage 2: Twelve weeks home-based program (3 sessions/week) with weekly telephone support. These weekly 5-10 minute calls will be provided by a qualified health professional to discuss adherence and other issues (e.g. symptoms). There is the option to replace one home-based session with a group class conducted by the Accredited Exercise Physiologist. Stage 3: Maintain home-based program (at least 3 sessions/week) for a further 6 months. Follow-up testing at 12 months from baseline measures. Adherence to exercise program will be monitored at supervised sessions (initial 12 weeks), home exercise log with weekly telephone follow-up (for subsequent 12 weeks), and 7-day accelerometer data at each testing period (baseline, 12 weeks, 24 weeks, 12 months). Compliance will be assessed as 70% adherence to recommended exercise program (intensity, type, time, and frequency) Dietary control will also be monitored on 3 days prior to each testing period by a self-administered food diary.
Sponsors
Dr Tina Skinner
Study design
Allocation
Randomised controlled trial
Intervention model
Other
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
- Diagnosis of multiple myeloma - Free of any musculoskeletal, neurological, respiratory, metabolic or cardiovascular conditions that may prevent safe completion of the exercise demands of the study - Cognitively capable of consent
Exclusion criteria
- Abnormal resting electrocardiogram - Unstable angina - Cognitive impairment that impedes the ability to complete questionnaires - Any intellectual or physical disability which would make exercise intervention participation unsafe for the individual
Outcome results
None listed