NCT02855801

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 4, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 15, 2017

Status Verified

August 1, 2016

Enrollment Period

3.5 years

First QC Date

August 2, 2016

Last Update Submit

February 14, 2017

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (1)

  • plasma concentration of C-reactive protein

    48 hours after the end of the exercise

Study Arms (4)

constant exercise without cryotherapy

EXPERIMENTAL

constant exercise without cryotherapy

Other: constant exercise

constant exercise with cryotherapy

EXPERIMENTAL

constant exercise with cryotherapy

Other: constant exerciseOther: cryotherapy

intermittent exercise, no cryotherapy

EXPERIMENTAL

intermittent exercise without cryotherapy

Other: intermittent exercise

intermittent exercise and cryotherapy

EXPERIMENTAL

intermittent exercise with cryotherapy

Other: cryotherapyOther: intermittent exercise

Interventions

constant exerciseOTHER
constant exercise with cryotherapyconstant exercise without cryotherapy
cryotherapyOTHER
constant exercise with cryotherapyintermittent exercise and cryotherapy
intermittent exerciseOTHER
intermittent exercise and cryotherapyintermittent exercise, no cryotherapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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 ...)
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Régional Universitaire

Besançon, Franche-Comté, 25030, France

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

CryotherapyHigh-Intensity Interval Training

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Clement Pati, MD

    CHRU Besancon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2016

First Posted

August 4, 2016

Study Start

June 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

February 15, 2017

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)