Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A01123-46 | Other Identifier | ANSM |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | patient will receive advices about benefit to practice physical activity, only once at the beginning of their treatment. Evaluation including 6 minutes walk test, chair stand test, gait-speed test, evaluation of maximum isometric strength of the quadriceps, quality of lif questionnaries, PRO, treatment tolerance, response evaluation will be held at inclusion, 3 months later and 6 months later. | |
| Experimental group | Experimental | patient will follow an adapted physical activity program with presential (every 2 weeks the first 3 months, then once a month for 3 months) and distancial (3 times per week for 6 months) sessions.Evaluation including 6 minutes walk test, chair stand test, gait-speed test, evaluation of maximum isometric strength of the quadriceps, quality of lif questionnaries, PRO, treatment tolerance, response evaluation will be held at inclusion, 3 months later and 6 months later. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adapted physical activity | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months post inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 and 6 months after inclusion |
| study the effect of 6 months intervention on objective and subjective level of physical activity |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Charlene DUPRE | Contact | +33479965910 | charlene.dupre@ch-metropole-savoie.fr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Annecy Genevois | Recruiting | Annecy | 74374 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
mean daily time in moderate to elevate intensity during intervention and IPAQ score at 3 and 6 months |
| 3 months and 6 months after inclusion |
| 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 | 3 and 6 months post inclusion |
| Study effect of 6 months intervention on muscular mass | compare between both groups muscular surface on CT scan at L3 level at 6 months | 6 months post inclusion |
| study the effect of 6 months intervention on osteolytic lesion | compare evolution of osteolytic lesionnel volume at 6 months between both group | 6 months post inclusion |
| faisability of the intervention in population of interest | number realised session in experimental group | from frist intervention day to 6 months |
| study the effect of 6 months intervention on patient tolerance to immunomodulators | dose adaptation number during 6 months and incidence of gastrointestinal symptoms thanks to NCI-PRO-CTCAE custom survey | from inclusion to end of intervention |
| study effect of 6 months intervention on immunomodulators treatment response | objective response rate at 3 and 6 months accroding to IMWG | 3 and 6 months after inclusion |
| Identification of the factors mediating the improvement in quality of life following the intervention | Multivariate analysis including the changes of quality of life (before/after intervention) as dependant variable and changes in exercise tolerance (6-minutes walking distance), Bone pain (FACT-Bone Pain), muscle mass (L3 section on CT-scan), osteolytic lesion on CT-scan and tolerance to immunomodulators as independant variables. The variables selection will be based on stepwise regression. | 0 and 6 months of intervention |
| safety of the intervention | incidence, type, severity, relationship of adverse event and intervention | from 0 to 6 months |
| study effect of 6 months of intervention on disease-specific patient's reported outcomes (FACT-MM) | compare FACT-MM score at 3 and 6 months betaween both groups | 3 and 6 months post inclusion |
| CH Métropole Savoie | Recruiting | Chambéry | 73000 | France |
|
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001519 | Behavior |
Not provided
Not provided