Exercise Training in Patients With Rheumatoid Arthritis and Cryotherapy

Not Applicable

Terminated

• Conditions: Arthritis, Rheumatoid
• Interventions: Other: constant exercise; Other: cryotherapy; Other: intermittent exercise

• Registration Number: NCT02855801
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Status Verified: 2016-08
• Study First Submitted: 2016-08-02
• Study First Submitted QC: 2016-08-03
• Study First Posted: 2016-08-04
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2017-02-14
• Last Update Posted: 2017-02-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intermittent exercise and cryotherapy	intermittent exercise	intermittent exercise with cryotherapy
constant exercise without cryotherapy	constant exercise	constant exercise without cryotherapy
intermittent exercise, no cryotherapy	intermittent exercise	intermittent exercise without cryotherapy
intermittent exercise and cryotherapy	cryotherapy	intermittent exercise with cryotherapy
constant exercise with cryotherapy	constant exercise	constant exercise with cryotherapy
constant exercise with cryotherapy	cryotherapy	constant exercise with cryotherapy

Primary Outcome Measures

Name	Time	Method
plasma concentration of C-reactive protein	48 hours after the end of the exercise

Trial Locations

Locations (1)

Centre Hospitalier Régional Universitaire; 🇫🇷 Besancon, Franche-Comté, France