Sarcopenia in Axial and Peripheral Spondyloarthropathies (SASPAR)

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.

Study Overview

• Status: Completed
• Conditions: Sarcopenia; Spondylarthropathy
• Intervention / Treatment: Other: Dynamometry exam; Other: Walking test; Radiation: DXA measurement; Other: SARQOL questionnaire; Behavioral: Life habits Questionnaire

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69003
    • Service de Rhumatologie - Hôpital Edouard Herriot

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alcohol consumption		At day 1
Tobacco consumption		At day 1
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.	At day 1
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.	At day 1
Average walking time in a week	Average walking time in a week is the third outcome to evaluate patient's physical global activity.	At day 1
Score at the SARQOL questionnaire	Quality of life will be assessed thanks to the SARQOL questionnaire (score between 0 and 100)	At day 1

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2017
• Primary Completion (Actual): July 4, 2018
• Study Completion (Actual): July 4, 2018

Study Registration Dates

• First Submitted: October 18, 2017
• First Submitted That Met QC Criteria: October 23, 2017
• First Posted (Actual): October 24, 2017

Study Record Updates

• Last Update Posted (Actual): September 7, 2018
• Last Update Submitted That Met QC Criteria: September 6, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: lean mass; Sarcopenia; fat mass; Spondylarthropathy
• Additional Relevant MeSH Terms: Nervous System Diseases; Infections; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthritis; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Muscular Atrophy; Atrophy; Bone Diseases, Infectious; Sarcopenia; Spondylitis; Spondylarthritis; Spondylarthropathies
• Other Study ID Numbers: 69HCL17_0145; 2017-A02391-52 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No