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Benefits of a 6-month, Individualized, Hybrid, Real-life Adapted Physical Activity Program on Quality of Life in Patients Treated for Multiple Myeloma: a Multicenter Randomized Controlled Trial
Led by Centre Hospitalier Metropole Savoie · Updated on 2026-04-23
86
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of a long-term, individualized, hybrid adapted physical activity program on the quality of life of patients treated for multiple myeloma. The study aims to determine if this 6-month program can improve quality of life and impact factors such as effort tolerance, pain, muscle mass, osteolytic lesions, treatment tolerance, and treatment response. Participants will be randomly assigned to either a control group receiving physical activity advice or an intervention group following the adapted physical activity program. The intervention group will engage in a "real life" hybrid adapted physical activity program combining in-person sessions at the hospital every two weeks for the first three months, then once a month for the following three months, with home-based sessions three times per week over six months. The control group will receive advice about the benefits of physical activity only once at the start of treatment. Both groups will undergo evaluations including a 6-minute walk test, chair stand test, gait-speed test, quadriceps strength assessment, quality of life questionnaires, patient-reported outcomes, treatment tolerance, and response evaluation at inclusion, 3 months, and 6 months. Participants will be involved in scheduled assessments at baseline, 3 months, and 6 months to measure physical function, quality of life, treatment tolerance, and response to treatment. Researchers will monitor the safety and feasibility of the intervention, study changes in physical activity levels, bone pain, muscle mass, osteolytic lesions, and disease-specific patient-reported outcomes. The primary outcome is the comparison of quality of life summary scores at 6 months between groups, with additional measurements taken throughout the study to understand the effects of the physical activity program.
CONDITIONS
Brief Title
Benefits of a 6-month, Individualized, Hybrid, "Real-life" Adapted Physical Activity Program on the Quality of Life of Patients Treated for Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed or relapsed multiple myeloma patients older than 60 years not eligible for transplant
- Receiving first to fourth line of treatment started within the last 3 months
- Undergoing systemic treatment with hospital visits at least twice a month for the first 3 months and at least once a month for the next 3 months
You will not qualify if you...
- Severe cardiac amyloidosis
- Absolute contraindication to physical activity
- Unable to comply with the study protocol requirements
- Not a French speaker
- Under guardianship or curatorship
- Pregnant or lactating women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants follow a 6-month individualized, hybrid adapted physical activity program that includes in-person sessions at the hospital and home-based sessions.
In-person visits every 2 weeks for the first 3 months, then once a month for the next 3 months; home sessions 3 times per week for 6 months
Duration - 6 months
Participants undergo evaluations including physical tests and quality of life assessments at 3 and 6 months after starting the program.
3 visits at inclusion, 3 months, and 6 months (in-person)
Trial Site Locations
Total: 2 locations
1
CH Annecy Genevois
Annecy, France, 74374
Actively Recruiting
2
CH Métropole Savoie
Chambéry, France, 73000
Actively Recruiting
Research Team
C
Charlene DUPRE
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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