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Sarcopenia in Axial and Peripheral Spondyloarthropathies (SASPAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03319264
Recruitment Status : Completed
First Posted : October 24, 2017
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

Spondylarthropathies (SpA) are among the most common chronic inflammatory rheumatisms in adults, responsible for a muscular loss or sarcopenia which can be very disabling, not much documented in the literature, and not yet studied in France. In addition, sarcopenia is associated with decreased physical activity and increased risk of falls and fractures. A better characterization of the determinants of this muscular loss will allow to better detect and take care of it.

The aim is to conduct the first French study on the prevalence and severity of sarcopenia in patients with spondyloarthropathies and to study the variables that may be associated with it. Finally, we propose to evaluate obesity related to sarcopenia in these patients and compare them to cases matched for age and sex (from OFELY / STRAMBO cohorts, Lyon, FRANCE).

This is a prospective interventional and monocentric study with minimal risks and constraints: patients will be included for one day for an evaluation of their sarcopenia by measuring their muscle strength, physical performance and body composition and recording of their socio-demographic and disease characteristics.


Condition or disease Intervention/treatment Phase
Spondylarthropathy Sarcopenia Other: Dynamometry exam Other: Walking test Radiation: DXA measurement Other: SARQOL questionnaire Behavioral: Life habits Questionnaire Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Sarcopenia in Axial and Peripheral Spondyloarthropathies
Actual Study Start Date : November 2, 2017
Actual Primary Completion Date : July 4, 2018
Actual Study Completion Date : July 4, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients with SpA

Patients included in this single group study will have 3 interventions to assess the severity of muscle loss :

  • dynamometry exam
  • walking test
  • Dual-energy X-ray Absorptiometry (DXA) measurement Quality of life will be assessed with Sarcopenia & Quality of Life (SARQOL) questionnaire. Patients will also fill a Life habits Questionnaire.
Other: Dynamometry exam
Prehension strength of the main hand will be assessed thanks to dynamometry, in order to evaluate patient's muscular strength

Other: Walking test
A 4 metres walking test will be performed to assess patient's walking speed

Radiation: DXA measurement
DXA measurement will be performed to assess patient's body composition

Other: SARQOL questionnaire
Patient's quality of life will be assessed thanks to the SARQOL questionnaire

Behavioral: Life habits Questionnaire
Life habits Questionnaire




Primary Outcome Measures :
  1. Muscular strength [ Time Frame: At day 1 ]
    Muscular strength is the first outcome to evaluate sarcopenia

  2. Walking speed [ Time Frame: At day 1 ]
    Walking speed is a physical performance outcome, that is the second outcome to evaluate sarcopenia

  3. Muscular mass [ Time Frame: Up to 4 month after inclusion ]
    Muscular mass is the third outcome to evaluate sarcopenia and will be assessed using DXA


Secondary Outcome Measures :
  1. Alcohol consumption [ Time Frame: At day 1 ]
  2. Tobacco consumption [ Time Frame: At day 1 ]
  3. Time of sport practice per month [ Time Frame: At day 1 ]
    Number of hours of sport practice per month is the first outcome to evaluate patient's global physical activity.

  4. Physical activity rate in work [ Time Frame: At day 1 ]
    Physical activity rate in work can be light, medium, high or not applicable if the patient does not work ; it is the second outcome to evaluate patient's physical global activity.

  5. Average walking time in a week [ Time Frame: At day 1 ]
    Average walking time in a week is the third outcome to evaluate patient's physical global activity.

  6. Score at the SARQOL questionnaire [ Time Frame: At day 1 ]
    Quality of life will be assessed thanks to the SARQOL questionnaire (score between 0 and 100)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women, 18 to 80 years old
  • Hospitalized or attending the rheumatology department for spondyloarthopathy.

Exclusion Criteria:

  • no signed consent
  • Immobilization for a period of more than 15 days during the last 3 months
  • pregnant or breastfeeding woman
  • Not affiliated to the national healthcare insurance
  • difficulty in understanding French
  • psychiatric disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03319264


Locations
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France
Service de Rhumatologie - Hôpital Edouard Herriot
Lyon, France, 69003
Sponsors and Collaborators
Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03319264     History of Changes
Other Study ID Numbers: 69HCL17_0145
2017-A02391-52 ( Other Identifier: ID-RCB )
First Posted: October 24, 2017    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
Spondylarthropathy
Sarcopenia
lean mass
fat mass
Additional relevant MeSH terms:
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Spondylarthropathies
Spondylarthritis
Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases