Benefits of a 6-month, Individualized, Hybrid, "Real-life" Adapted Physical Activity Program on the Quality of Life of Patients Treated for Multiple Myeloma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Adapted physical activity.
- Who it may be relevant to
- Registry conditions: Multiple Myeloma (MM). Basic parameters: from 61 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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: a Multicenter Randomized Controlled Trial
Overview
The goal of this clinical trial is to evaluate the effect of a long-term, individualized, hybrid adapted physical activity program on the quality of life of patients with multiple myeloma. The main question it aims to answer are : Does this logn term, individualized and hybrid adapted physical activity program improve quality of life in multiple myeloma patient ? What are the effects of this program on effort tolerance, pain, muscular mass, osteolytic lesions, tolerance to treatment, response to treatment? If there is a comparison group: Researchers will compare \[arm information\] to see if \[insert effects\]. Participants will be randomised in 2 groups. * control group: patients will receive only advices about physical activities benefit * interventional group: This group will be offered a program of adapted physical activities mixing sessions at home (remote) and sessions at the hospital (in person).
Interventions
- Procedure Adapted physical activity
the intervention is a "real life"6 months adapted physical activity program which is individualised and hybrid (presential and distancial) . It includes a session in presential (at hospital) every 2 weeks for the first 3 months then once a month and 3 sessions par week for 6 months at home.
Primary outcome measures
- compare EORTC-QLQ-C30 summary score at 6 months between both groups [Time frame: 6 months post inclusion]
Secondary outcome measures (11)
- compare functional and symptomatic dimension of EORTC-QLQ-C30 at 3 and 6 months between both groups [Time frame: 3 and 6 months after inclusion]
- study the effect of 6 months intervention on objective and subjective level of physical activity [Time frame: 3 months and 6 months after inclusion]
- study effect of 6 months of intervention on bone pain (FACT-Bone) evolution [Time frame: 3 and 6 months post inclusion]
- Study effect of 6 months intervention on muscular mass [Time frame: 6 months post inclusion]
- study the effect of 6 months intervention on osteolytic lesion [Time frame: 6 months post inclusion]
- faisability of the intervention in population of interest [Time frame: from frist intervention day to 6 months]
- study the effect of 6 months intervention on patient tolerance to immunomodulators [Time frame: from inclusion to end of intervention]
- study effect of 6 months intervention on immunomodulators treatment response [Time frame: 3 and 6 months after inclusion]
- Identification of the factors mediating the improvement in quality of life following the intervention [Time frame: 0 and 6 months of intervention]
- safety of the intervention [Time frame: from 0 to 6 months]
- study effect of 6 months of intervention on disease-specific patient's reported outcomes (FACT-MM) [Time frame: 3 and 6 months post inclusion]
Eligibility criteria
Inclusion criteria
- newly diagnosed or relapse multiple myeloma, > 60 yo, not eligible to transplant
- 1st to 4th line of treatment initiated during the last 3 months
- receiving a systemic treatment that involved visit to the hospital at least twice a month durig the first 3 months and at least once a month the next 3 months
Exclusion criteria
- severe cardiac amyloidosis
- absolute contraindication to physical activity
- inability to comply with the protocol requirements
- not french speaker
- patient under guardianship or curatorship
- pregnant or lactating women
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 2 centers
- CH Annecy Genevois — Annecy
- CH Métropole Savoie — Chambéry
Identifiers
NCT: NCT07547007 · CHMS25006 · 2025-A01123-46