Exercise Training in Patients With Rheumatoid Arthritis and Cryotherapy (RhumatEx)

Centre Hospitalier Universitaire de Besancon

Status: Terminated

Conditions: Arthritis, Rheumatoid

Treatments: Other: constant exercise; Other: intermittent exercise; Other: cryotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02855801

P/2012/139

Details and patient eligibility

About

The main objective of this project is to study, in patients with rheumatoid arthritis, the effects of an intermittent type exercise associated with cryotherapy on the level of inflammation during its recovery.

Enrollment: 8 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women >18 years old, < 80 years old
• Signature of informed consent for participation
• Affiliation to a social security scheme or French beneficiary of such a regime.
• confirmed rheumatoid arthritis and monitoring by the rheumatology department of the University Hospital of Besancon.
• If there is a corticosteroid therapy, it must be stable for at least 1 month and less than or equal to 10 mg of prednisone equivalent per day
• Clinical and biological activity will be moderate (ie not in remission and not severe based on Disease Activity Score 28 joints - DAS 28 - to be between 2 and 6
• Patients could be treated with DMARDs (Disease-Modifying Drugs).

Exclusion criteria

• Patient under guardianship, curatorship, under judicial protection, major incapable
• Patients whose body mass index (BMI) greater than 30,
• Pathology incompatible with the completion of a cycle ergometer exercise (heart, vascular, respiratory, orthopedic ...)
• Change in DAS28 greater than 1.2 in the previous 3 months Inclusion
• A patient with a DAS28 > 6
• about the cold: Raynaud's syndrome, cold known allergy, sickle cell anemia, cryoglobulinemia, uncontrolled hypertension
• Patient unable to follow protocol because of cognitive, psychiatric or language difficulties.
• Inability to follow protocol for causes related to health problems (unrelated Rheumatoid Arthritis) or socio-professional.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

8 participants in 4 patient groups

constant exercise without cryotherapy

Experimental group

Description:

constant exercise without cryotherapy

Treatment:

Other: constant exercise

constant exercise with cryotherapy

Experimental group

Description:

constant exercise with cryotherapy

Treatment:

Other: constant exercise

Other: cryotherapy

intermittent exercise, no cryotherapy

Experimental group

Description:

intermittent exercise without cryotherapy

Treatment:

Other: intermittent exercise

intermittent exercise and cryotherapy

Experimental group

Description:

intermittent exercise with cryotherapy

Treatment:

Other: intermittent exercise

Other: cryotherapy