Exercise Training in Patients With Rheumatoid Arthritis and Cryotherapy

NCT ID: NCT02855801

Last Updated: 2017-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2016-12-31

Brief Summary

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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

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Conditions

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Arthritis, Rheumatoid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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constant exercise without cryotherapy

constant exercise without cryotherapy

Group Type EXPERIMENTAL

constant exercise

Intervention Type OTHER

constant exercise with cryotherapy

constant exercise with cryotherapy

Group Type EXPERIMENTAL

constant exercise

Intervention Type OTHER

cryotherapy

Intervention Type OTHER

intermittent exercise, no cryotherapy

intermittent exercise without cryotherapy

Group Type EXPERIMENTAL

intermittent exercise

Intervention Type OTHER

intermittent exercise and cryotherapy

intermittent exercise with cryotherapy

Group Type EXPERIMENTAL

cryotherapy

Intervention Type OTHER

intermittent exercise

Intervention Type OTHER

Interventions

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constant exercise

Intervention Type OTHER

cryotherapy

Intervention Type OTHER

intermittent exercise

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clement Pati, MD

Role: PRINCIPAL_INVESTIGATOR

CHRU Besancon

Locations

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Centre Hospitalier Régional Universitaire

Besançon, Franche-Comté, France

Site Status

Countries

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France

Other Identifiers

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P/2012/139

Identifier Type: -

Identifier Source: org_study_id

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