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

Primary Purpose

Arthritis, Rheumatoid

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
constant exercise
cryotherapy
intermittent exercise
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis, Rheumatoid

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Centre Hospitalier Régional Universitaire

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

constant exercise without cryotherapy

constant exercise with cryotherapy

intermittent exercise, no cryotherapy

intermittent exercise and cryotherapy

Arm Description

constant exercise without cryotherapy

constant exercise with cryotherapy

intermittent exercise without cryotherapy

intermittent exercise with cryotherapy

Outcomes

Primary Outcome Measures

plasma concentration of C-reactive protein

Secondary Outcome Measures

Full Information

First Posted
August 2, 2016
Last Updated
February 14, 2017
Sponsor
Centre Hospitalier Universitaire de Besancon
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1. Study Identification

Unique Protocol Identification Number
NCT02855801
Brief Title
Exercise Training in Patients With Rheumatoid Arthritis and Cryotherapy
Acronym
RhumatEx
Official Title
Exercise Training in Patients With Rheumatoid Arthritis and Cryotherapy: Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
constant exercise without cryotherapy
Arm Type
Experimental
Arm Description
constant exercise without cryotherapy
Arm Title
constant exercise with cryotherapy
Arm Type
Experimental
Arm Description
constant exercise with cryotherapy
Arm Title
intermittent exercise, no cryotherapy
Arm Type
Experimental
Arm Description
intermittent exercise without cryotherapy
Arm Title
intermittent exercise and cryotherapy
Arm Type
Experimental
Arm Description
intermittent exercise with cryotherapy
Intervention Type
Other
Intervention Name(s)
constant exercise
Intervention Type
Other
Intervention Name(s)
cryotherapy
Intervention Type
Other
Intervention Name(s)
intermittent exercise
Primary Outcome Measure Information:
Title
plasma concentration of C-reactive protein
Time Frame
48 hours after the end of the exercise

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clement Pati, MD
Organizational Affiliation
CHRU Besancon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Régional Universitaire
City
Besancon
State/Province
Franche-Comté
ZIP/Postal Code
25030
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Exercise Training in Patients With Rheumatoid Arthritis and Cryotherapy

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