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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05548686
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University Hospital, Caen
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma, Adapted Physical Activity, Chronic Pain
Arms & Interventions

Arms

Experimental: Adapted Physical Activity

Patients benefiting from adapted physical activity

Interventions

Other: - adapted physical activity

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

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.