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

February 14, 2017 updated by: Centre Hospitalier Universitaire de Besancon

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Franche-Comté
      • Besancon, Franche-Comté, France, 25030
        • Centre Hospitalier Régional Universitaire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: constant exercise without cryotherapy
Other: constant exercise
Experimental: constant exercise with cryotherapy
Other: cryotherapy
Other: constant exercise
Experimental: intermittent exercise, no cryotherapy
intermittent exercise without cryotherapy
Other: intermittent exercise
Experimental: intermittent exercise and cryotherapy
intermittent exercise with cryotherapy
Other: cryotherapy
Other: intermittent exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
plasma concentration of C-reactive protein
Time Frame: 48 hours after the end of the exercise
48 hours after the end of the exercise

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Investigators

  • Principal Investigator: Clement Pati, MD, CHRU Besançon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

August 2, 2016

First Submitted That Met QC Criteria

August 3, 2016

First Posted (Estimate)

August 4, 2016

Study Record Updates

Last Update Posted (Actual)

February 15, 2017

Last Update Submitted That Met QC Criteria

February 14, 2017

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P/2012/139

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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