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Trial Title:
Benefits of Adapted Physical Activity for Chronic Osteoarticular Pain in Patients With Multiple Myeloma
NCT ID:
NCT05548686
Condition:
Multiple Myeloma
Adapted Physical Activity
Chronic Pain
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Chronic Pain
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
adapted physical activity
Description:
3 sessions of adapted physical activity per week during 12 weeks for each patient
Arm group label:
Adapted Physical Activity
Summary:
Pain is one of the most frequent symptoms leading patients to consult a doctor,
particularly in rheumatology and cancerology. When it becomes chronic, pain is the cause
of a major emotional and physical invasion, with harmful repercussions on the family,
social and professional levels. It is therefore necessary to be able to propose different
therapies.
For many years, non-medicinal techniques have been proving their benefits and their
central role in the treatment of chronic pain. Physical activity has been widely
demonstrated in the literature to have considerable physical benefits (reduced risk of
hypertension, vascular accidents, diabetes, improved bone condition, weight control,
etc.) but also psychological benefits. However, according to the WHO, nearly 31% of
adults aged 15 and over were not physically active in 2008. Physical inactivity is
considered the 4th leading risk factor for death in the world. It is estimated to be the
main cause of 21 to 25% of breast and colon cancers.
The investigators therefore propose a feasibility study, interventional, with minimal
risks and constraints, evaluating the effectiveness of adapted physical activity in
chronic pain related to a pathology little studied in this field of management: multiple
myeloma. This study will include about 15 patients with residual pain 3 months after the
end of their induction chemotherapy treatment.
Adapted Physical Activity sessions will be performed for 12 weeks. The evaluation of the
expected benefits on pain and its consequences (cognitive, emotional, behavioral,
physical ...) will be done through simple and validated questionnaires as well as on the
evolution of the consumption of analgesics. The expected duration of the study will be
one year.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients with chronic pain related to multiple myeloma, which has been evolving for
more than 3 months and whose intensity is assessed with a VAS > 30/100
- Patients who have completed more than 3 months of induction chemotherapy for
Multiple Myeloma.
- Patients not eligible for bone marrow transplantation.
- Patient able to read, understand French and self-assess their pain on the VAS
- Patient followed in the haematology department of the Caen University Hospital
and living in Calvados
Exclusion Criteria:
- Patients with absolute contraindications to Adapted Physical Activity.
- Unstable angina
- Decompensated heart failure
- Complex ventricular rhythm disorders
- Severe uncontrolled hypertension
- PAH > 60mmHg
- Presence of large or pedunculated intra-cavity thrombus
- Acute pericardial effusion
- Severe obstructive cardiomyopathy
- Tight and/or symptomatic aortic stenosis
- Recent thrombophlebitis with or without pulmonary embolism
- Diabetes with plantar perforating disease for activities involving the lower
limbs
- Patient eligible for a bone marrow transplant.
- Patients with a major and/or potentially dangerous osteolytic lesion.
- Patients who do not meet the criteria for "moderate" functional impairment (assessed
at the inclusion visit). defined by the HAS in 2019
- Pregnant or lactating woman.
- Minor patient.
- Patient under legal protection.
- Patient who does not read or understand French.
- Patient undergoing physiotherapy at the time of inclusion.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
November 2022
Completion date:
April 2023
Lead sponsor:
Agency:
University Hospital, Caen
Agency class:
Other
Source:
University Hospital, Caen
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05548686