Exercise Training in Patients With Rheumatoid Arthritis and Cryotherapy

Arthritis, Rheumatoid Clinical Trial

— RhumatEx  

Official title:

Exercise Training in Patients With Rheumatoid Arthritis and Cryotherapy: Feasibility Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02855801
• Other study ID #: P/2012/139
• Status: Terminated
• Phase: N/A
• First received: August 2, 2016
• Last updated: February 14, 2017
• Start date: June 2013
• Est. completion date: December 2016

Study information

• Verified date: August 2016
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

Other:
• constant exercise

• cryotherapy

• intermittent exercise

Locations

Country	Name	City	State
France	Centre Hospitalier Régional Universitaire	Besancon	Franche-Comté

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plasma concentration of C-reactive protein		48 hours after the end of the exercise