About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
severe cardiac amyloidosis
absolute contraindication to physical activity
inability to comply with the protocol requirements
not french speaker
Trial design
Parallel
Treatments tested in this trial
Adapted physical activity
Procedure/Surgerythe 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.
Treatment groups
Trial outcomes
Primary outcomes
compare EORTC-QLQ-C30 summary score at 6 months between both groups
EORTC-QLQ-C30 questionnaire will be given to participant at inclusion and at 6 months, score will be calculated
Secondary outcomes
compare functional and symptomatic dimension of EORTC-QLQ-C30 at 3 and 6 months between both groups
score of functional and symptomatic dimension of EORTC-QLQ-C30 will be calculated and compared between both groups
study the effect of 6 months intervention on objective and subjective level of physical activity
mean daily time in moderate to elevate intensity during intervention and IPAQ score at 3 and 6 months
study effect of 6 months of intervention on bone pain (FACT-Bone) evolution
compare FACT-Bone pain score at 3 and 6 months betaween both groups
Study effect of 6 months intervention on muscular mass
compare between both groups muscular surface on CT scan at L3 level at 6 months
Sponsors and contacts
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