Clinical trial NCT05548686: Benefits of Adapted Physical Activity for Chronic Osteoarticular Pain in Patients With Multiple Myeloma
Official title: Benefits of Adapted Physical Activity for Chronic Osteoarticular Pain in Patients With Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Myeloma
Adapted Physical Activity
Chronic Pain
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.


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.

Primary outcomes:
measure: To evaluate the impact of adapted physical activity on the intensity of chronic pain related to multiple myeloma
timeFrame: difference between Month 0, Month 3, Month 6
Secondary outcomes:
measure: Evaluate the impact of adapted physical activity on pain
timeFrame: difference between Month 0, Month 3, Month 6
measure: To evaluate the impact of APA on the consumption of analgesics.
timeFrame: difference between Month 0, Month 3, Month 6
measure: Evaluate the impact of adapted physical activity on catastrophizing
timeFrame: difference between Month 0, Month 3, Month 6
measure: Evaluate the impact of adapted physical activity on anxiety and depression
timeFrame: difference between Month 0, Month 3, Month 6
measure: Evaluate the impact of adapted physical activity on sleep
timeFrame: difference between Month 0, Month 3, Month 6
measure: Evaluate the impact of adapted physical activity on physical activity
timeFrame: difference between Month 0, Month 3, Month 6
measure: Evaluate the impact of adapted physical activity on self-esteem
timeFrame: difference between Month 0, Month 3, Month 6
measure: Evaluate the impact of adapted physical activity on quality of life
timeFrame: difference between Month 0, Month 3, Month 6
Other outcomes:
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