Benefits of Adapted Physical Activity for Chronic Osteoarticular Pain in Patients With Multiple Myeloma

NCT05548686 | Unknown

• 2 other identifiers: 20-1632020-A02599-30
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Myeloma; Adapted Physical Activity; Chronic Pain

Outcome Measures

Primary Outcomes (1)

• To evaluate the impact of adapted physical activity on the intensity of chronic pain related to multiple myeloma

  Evaluation of the pain intensity with the visual analogue scale from 0 to 100 (with the help of the ruler) over time

  difference between Month 0, Month 3, Month 6

Secondary Outcomes (8)

• Evaluate the impact of adapted physical activity on pain

  difference between Month 0, Month 3, Month 6

• To evaluate the impact of APA on the consumption of analgesics.

  difference between Month 0, Month 3, Month 6

• Evaluate the impact of adapted physical activity on catastrophizing

  difference between Month 0, Month 3, Month 6

• Evaluate the impact of adapted physical activity on anxiety and depression

  difference between Month 0, Month 3, Month 6

• Evaluate the impact of adapted physical activity on sleep

  difference between Month 0, Month 3, Month 6

Study Arms (1)

Adapted Physical Activity

EXPERIMENTAL

Patients benefiting from adapted physical activity

Other: adapted physical activity

Interventions

adapted physical activity OTHER

3 sessions of adapted physical activity per week during 12 weeks for each patient

Adapted Physical Activity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Pregnant or lactating woman.

Sponsors & Collaborators

• University Hospital, Caen: lead

MeSH Terms

Conditions

Multiple Myeloma; Chronic Pain

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: September 21, 2022
• Study Start: November 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: September 21, 2022

Record last verified: 2021-12