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Sarcopenia in Axial and Peripheral Spondyloarthropathies (SASPAR)

Primary Purpose

Spondylarthropathy, Sarcopenia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Dynamometry exam
Walking test
DXA measurement
SARQOL questionnaire
Life habits Questionnaire
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Spondylarthropathy focused on measuring Spondylarthropathy, Sarcopenia, lean mass, fat mass

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service de Rhumatologie - Hôpital Edouard Herriot

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with SpA

Arm Description

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.

Outcomes

Primary Outcome Measures

Muscular strength
Muscular strength is the first outcome to evaluate sarcopenia
Walking speed
Walking speed is a physical performance outcome, that is the second outcome to evaluate sarcopenia
Muscular mass
Muscular mass is the third outcome to evaluate sarcopenia and will be assessed using DXA

Secondary Outcome Measures

Alcohol consumption
Tobacco consumption
Time of sport practice per month
Number of hours of sport practice per month is the first outcome to evaluate patient's global physical activity.
Physical activity rate in work
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.
Average walking time in a week
Average walking time in a week is the third outcome to evaluate patient's physical global activity.
Score at the SARQOL questionnaire
Quality of life will be assessed thanks to the SARQOL questionnaire (score between 0 and 100)

Full Information

First Posted
October 18, 2017
Last Updated
September 6, 2018
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT03319264
Brief Title
Sarcopenia in Axial and Peripheral Spondyloarthropathies
Acronym
SASPAR
Official Title
Sarcopenia in Axial and Peripheral Spondyloarthropathies
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
November 2, 2017 (Actual)
Primary Completion Date
July 4, 2018 (Actual)
Study Completion Date
July 4, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondylarthropathy, Sarcopenia
Keywords
Spondylarthropathy, Sarcopenia, lean mass, fat mass

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with SpA
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Dynamometry exam
Intervention Description
Prehension strength of the main hand will be assessed thanks to dynamometry, in order to evaluate patient's muscular strength
Intervention Type
Other
Intervention Name(s)
Walking test
Intervention Description
A 4 metres walking test will be performed to assess patient's walking speed
Intervention Type
Radiation
Intervention Name(s)
DXA measurement
Intervention Description
DXA measurement will be performed to assess patient's body composition
Intervention Type
Other
Intervention Name(s)
SARQOL questionnaire
Intervention Description
Patient's quality of life will be assessed thanks to the SARQOL questionnaire
Intervention Type
Behavioral
Intervention Name(s)
Life habits Questionnaire
Intervention Description
Life habits Questionnaire
Primary Outcome Measure Information:
Title
Muscular strength
Description
Muscular strength is the first outcome to evaluate sarcopenia
Time Frame
At day 1
Title
Walking speed
Description
Walking speed is a physical performance outcome, that is the second outcome to evaluate sarcopenia
Time Frame
At day 1
Title
Muscular mass
Description
Muscular mass is the third outcome to evaluate sarcopenia and will be assessed using DXA
Time Frame
Up to 4 month after inclusion
Secondary Outcome Measure Information:
Title
Alcohol consumption
Time Frame
At day 1
Title
Tobacco consumption
Time Frame
At day 1
Title
Time of sport practice per month
Description
Number of hours of sport practice per month is the first outcome to evaluate patient's global physical activity.
Time Frame
At day 1
Title
Physical activity rate in work
Description
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.
Time Frame
At day 1
Title
Average walking time in a week
Description
Average walking time in a week is the third outcome to evaluate patient's physical global activity.
Time Frame
At day 1
Title
Score at the SARQOL questionnaire
Description
Quality of life will be assessed thanks to the SARQOL questionnaire (score between 0 and 100)
Time Frame
At day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Service de Rhumatologie - Hôpital Edouard Herriot
City
Lyon
ZIP/Postal Code
69003
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Sarcopenia in Axial and Peripheral Spondyloarthropathies

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