NCT02320188

Brief Summary

The purpose of the study is to determine in a randomized controlled trial (RCT), the efficacy of eccentric exercise training in restoring muscle mass and function in patients with rheumatoid cachexia.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
unknown

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

December 1, 2014

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 19, 2014

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

February 4, 2019

Status Verified

February 1, 2019

Enrollment Period

4.2 years

First QC Date

December 16, 2014

Last Update Submit

February 1, 2019

Conditions

Rheumatoid Arthritis

Keywords

modification of treatment plannedExercise

Outcome Measures

Primary Outcomes (1)

  • Isometric knee extensor strength gain measured by an isokinetic dynamometer

    at 3 months

Secondary Outcomes (3)

  • improvement in muscle mass

    Up to 30 days before the beginning of the training, after 3 and 6 months

  • improvement in fonctional status

    At the beginning of the training, after 3 and 6 months

  • improvement in cardiovascular risk

    At the beginning of the training, after 3 and 6 months

Study Arms (3)

Eccentric exercise

EXPERIMENTAL

Thirty sessions of Eccentric training in twelve weeks. Average of two sessions per week without spacing higher than eight days between two sessions.

Other: Eccentric exercise

Concentric exercise

EXPERIMENTAL

Thirty sessions of Concentric training in twelve weeks. Average of three sessions per week without spacing higher than eight days between two sessions.

Other: Concentric exercise

No training (control)

NO INTERVENTION

Usual activities. No further training during the observation period

Interventions

Eccentric exerciseOTHER

This study aimed to determine the muscle effects of ECC training, with the primary outcome being the knee extensor strength gain at 3 months.

Eccentric exercise
Concentric exerciseOTHER

The purpose of the study is to determine in a randomized controlled trial (RCT), the efficacy of eccentric exercise training in restoring muscle mass and function in patients with rheumatoid cachexia.

Concentric exercise

Eligibility Criteria

Age40 Years - 66 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age from 40 to 66 years old
  • Diagnosis of rheumatoid arthritis according to ACR 1987 or ACR/EULAR 2010 criteria
  • Activity of the disease measured by the DAS28 ≤3.2
  • Stable for at least 3 months, no modification of treatment planned in the 3 months
  • Steroids prednisone ≤ 0.1 mg/kg/day
  • Steinbrocker functional classification for functional disability ≤ II
  • The Questionnaire of Baecke for measurement of physical activity \< 7.5
  • Stable nutritional diet
  • Patients resident in the area of "Grand Clermont"
  • Clinical cachexia as defined by upper arm muscle area ≤75th percentile for age and sex

You may not qualify if:

  • contraindication to exercise or to exercise stress test
  • advanced hip or knee osteoarthritis
  • Planned surgery of hip or knee
  • Hip or knee arthroplasty preventing pedaling
  • Chronic disease associated with cachexia
  • Nutritional intervention
  • Pregnancy
  • For muscle biopsy: contraindication to local anesthesia, anticoagulation therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Conditions

Arthritis, RheumatoidMotor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Anne TOURNADRE

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95placarin@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2014

First Posted

December 19, 2014

Study Start

December 1, 2014

Primary Completion

February 28, 2019

Study Completion

February 28, 2019

Last Updated

February 4, 2019

Record last verified: 2019-02

Locations

FR(1)