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Eccentric Exercise and Cachexia in Rheumatoid Arthritis (EECRA)

Primary Purpose

Rheumatoid Arthritis

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Eccentric exercise
Concentric exercise
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring modification of treatment planned, Exercise

Eligibility Criteria

40 Years - 66 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • CHU Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Eccentric exercise

Concentric exercise

No training (control)

Arm Description

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

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

Usual activities. No further training during the observation period

Outcomes

Primary Outcome Measures

Isometric knee extensor strength gain measured by an isokinetic dynamometer

Secondary Outcome Measures

improvement in muscle mass
quadriceps muscle volume
improvement in fonctional status
Body composition : Lean body mass, Appendicular lean mass
improvement in cardiovascular risk
Cardiovascular risk : arterial compliance

Full Information

First Posted
December 16, 2014
Last Updated
February 1, 2019
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT02320188
Brief Title
Eccentric Exercise and Cachexia in Rheumatoid Arthritis
Acronym
EECRA
Official Title
Effect of Eccentric Exercise Training in Rheumatoid Cachexia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
February 28, 2019 (Anticipated)
Study Completion Date
February 28, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

5. Study Description

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.
Detailed Description
Rheumatoid arthritis (RA) is characterized by severe disability and metabolic changes leading to an increase in cardiovascular mortality compared with the general population. RA is an independent cardiovascular risk factor. In contrast to the general population, RA patients with low body mass index (BMI) had a significantly higher risk of cardiovascular death. Low BMI may indicate rheumatoid cachexia and may explain the excess cardiovascular risk and mortality. Cachexia is defined by is a loss of body cell mass, predominantly in skeletal muscle, associated with increased fat mass and often stable weight. Rheumatoid cachexia, not well recognized, is frequent, affecting two third of patients. Pathogenesis may include inflammatory cytokine production, physical inactivity, higher catabolism and reduced peripheral insulin action. Therapeutic strategy includes increasing physical activity and the treatment of disease itself. Studies have shown that regular progressive resistance strength training improves strength and pain in patients with well-controlled RA without exacerbating disease activity or joint pain. At comparable mechanical power output, eccentric (ECC ) exercises are characterised by lower metabolic demand than concentric (CON) exercises. ECC exercise is characterised not only by its low energy cost, but also by specific cardiocirculatory specificity. In patients with Parkinson's disease, compared to a conventional rehabilitation programme, ECC training better improved quadriceps muscle volume. In overweight and diabetic patients, ECC training improved resting energy expenditure and fat oxidation, blood lipid profile and insulin resistance compared to CON training. As in cancers, ECC training appears to be particularly suitable for patients with rheumatoid cachexia as it can maximize the functional and structural muscle responses with low energy cost populations. This study aimed to determine the muscle effects of ECC training, with the primary outcome being the knee extensor strength gain at 3 months. Secondary outcomes are the improvement in muscle mass, functional status and cardiovascular risk. From patients who consented in ECC training group, muscle biopsy specimens from vastus lateralis will be obtained at baseline prior to the training period. Primary and secondary outcome criteria will be assessed at inclusion, at 3 months, and 6 months. In total, 48 patients will need to be recruited. These patients will be randomly assigned to one of the 3 groups, with each group comprising 16 patients: group 1 with ECC training, group 2 with CONC training, group 3 with no training (control). The training program will consist in 30 sessions over 12 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
modification of treatment planned, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Eccentric exercise
Arm Type
Experimental
Arm Description
Thirty sessions of Eccentric training in twelve weeks. Average of two sessions per week without spacing higher than eight days between two sessions.
Arm Title
Concentric exercise
Arm Type
Experimental
Arm Description
Thirty sessions of Concentric training in twelve weeks. Average of three sessions per week without spacing higher than eight days between two sessions.
Arm Title
No training (control)
Arm Type
No Intervention
Arm Description
Usual activities. No further training during the observation period
Intervention Type
Other
Intervention Name(s)
Eccentric exercise
Intervention Description
This study aimed to determine the muscle effects of ECC training, with the primary outcome being the knee extensor strength gain at 3 months.
Intervention Type
Other
Intervention Name(s)
Concentric exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Isometric knee extensor strength gain measured by an isokinetic dynamometer
Time Frame
at 3 months
Secondary Outcome Measure Information:
Title
improvement in muscle mass
Description
quadriceps muscle volume
Time Frame
Up to 30 days before the beginning of the training, after 3 and 6 months
Title
improvement in fonctional status
Description
Body composition : Lean body mass, Appendicular lean mass
Time Frame
At the beginning of the training, after 3 and 6 months
Title
improvement in cardiovascular risk
Description
Cardiovascular risk : arterial compliance
Time Frame
At the beginning of the training, after 3 and 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne TOURNADRE
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr

12. IPD Sharing Statement

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Eccentric Exercise and Cachexia in Rheumatoid Arthritis

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