CClinicalTrials.gg
Status unknownNCT02320188EECRAUpdated Feb 4, 2019

Eccentric Exercise and Cachexia in Rheumatoid Arthritis

An interventional study of Eccentric exercise and Concentric exercise in Rheumatoid Arthritis, sponsored by University Hospital, Clermont-Ferrand. Status unknown at 1 site in France. Open to female participants aged 40 Years to 66 Years. Per ClinicalTrials.gov, last updated 2019-02-04.

Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
40 Years to 66 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Rheumatoid Arthritis

Keywords

  • modification of treatment planned
  • Exercise
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's planned enrollment of 48 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 66 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
48 participants (estimated)

Study arms

  • Experimental
    Eccentric exercise

    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

  • Experimental
    Concentric exercise

    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 intervention
    No training (control)

    Usual activities. No further training during the observation period

Interventions

  • OtherEccentric exercise

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

  • OtherConcentric exercise

    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.

06

What researchers measure

Primary outcomes

  1. Isometric knee extensor strength gain measured by an isokinetic dynamometer

    Time frame: at 3 months

Secondary outcomes

  1. improvement in muscle mass

    quadriceps muscle volume

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

  2. improvement in fonctional status

    Body composition : Lean body mass, Appendicular lean mass

    Time frame: At the beginning of the training, after 3 and 6 months

  3. improvement in cardiovascular risk

    Cardiovascular risk : arterial compliance

    Time frame: At the beginning of the training, after 3 and 6 months

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02320188
Lead sponsor
University Hospital, Clermont-Ferrand
Responsible party
Sponsor
First posted
Dec 19, 2014
Start date
Dec 2014
Primary completion
Feb 28, 2019 (estimated)
Completion
Feb 28, 2019 (estimated)
Last update
Feb 4, 2019

Study contacts

Patrick LACARIN
Contact
placarin@chu-clermontferrand.fr
04 73 75 11 95
Anne TOURNADRE
principal investigator · University Hospital, Clermont-Ferrand
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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