NCT03319264

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 18, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 24, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

November 2, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2018

Completed
Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

8 months

First QC Date

October 18, 2017

Last Update Submit

December 13, 2025

Conditions

Keywords

SpondylarthropathySarcopenialean massfat mass

Outcome Measures

Primary Outcomes (3)

  • Muscular strength

    Muscular strength is the first outcome to evaluate sarcopenia

    At day 1

  • Walking speed

    Walking speed is a physical performance outcome, that is the second outcome to evaluate sarcopenia

    At day 1

  • Muscular mass

    Muscular mass is the third outcome to evaluate sarcopenia and will be assessed using DXA

    Up to 4 month after inclusion

Secondary Outcomes (6)

  • Alcohol consumption

    At day 1

  • Tobacco consumption

    At day 1

  • Time of sport practice per month

    At day 1

  • Physical activity rate in work

    At day 1

  • Average walking time in a week

    At day 1

  • +1 more secondary outcomes

Study Arms (1)

Patients with SpA

EXPERIMENTAL

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 examOther: Walking testRadiation: DXA measurementOther: SARQOL questionnaireBehavioral: Life habits Questionnaire

Interventions

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

Patients with SpA

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

Patients with SpA

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

Patients with SpA

Prehension strength of the main hand will be assessed thanks to dynamometry, in order to evaluate patient's muscular strength

Patients with SpA

Life habits Questionnaire

Patients with SpA

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Rhumatologie - Hôpital Edouard Herriot

Lyon, 69003, France

Location

Related Publications (1)

  • Merle B, Cottard M, Sornay-Rendu E, Szulc P, Chapurlat R. Spondyloarthritis and Sarcopenia: Prevalence of Probable Sarcopenia and its Impact on Disease Burden: The Saspar Study. Calcif Tissue Int. 2023 Jun;112(6):647-655. doi: 10.1007/s00223-023-01074-3. Epub 2023 Mar 21.

MeSH Terms

Conditions

SpondylarthropathiesSarcopenia

Condition Hierarchy (Ancestors)

SpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2017

First Posted

October 24, 2017

Study Start

November 2, 2017

Primary Completion

July 4, 2018

Study Completion

July 4, 2018

Last Updated

December 19, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations