Benefits of a 6-month, Individualized, Hybrid, "Real-life" Adapted Physical Activity Program on the Quality of Life of Patients Treated for Multiple Myeloma

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age61+
SponsorCentre Hospitalier Metropole Savoie

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Adapted physical activity

    Procedure/Surgery

    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.

Treatment groups

86 Participants
are divided into 2 treatment groups
Group A: Control groupNo intervention 0 interventions
Group B: Experimental groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
6 months post inclusion

Secondary outcomes

1

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

Time frame
3 and 6 months after inclusion
2

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

Time frame
3 months and 6 months after inclusion
3

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

Time frame
3 and 6 months post inclusion
4

Study effect of 6 months intervention on muscular mass

compare between both groups muscular surface on CT scan at L3 level at 6 months

Time frame
6 months post inclusion

Other outcomes

Sponsors and contacts

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