Sarcopenia in Axial and Peripheral Spondyloarthropathies

Sarcopenia Clinical Trial

— SASPAR  

Official title:

Sarcopenia in Axial and Peripheral Spondyloarthropathies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03319264
• Other study ID #: 69HCL17_0145
• Secondary ID: 2017-A02391-52
• Status: Completed
• Phase: N/A
• Start date: November 2, 2017
• Est. completion date: July 4, 2018

Study information

• Verified date: September 2018
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: July 4, 2018
• Est. primary completion date: July 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Sarcopenia
• Spondylarthritis
• Spondylarthropathies
• Spondylarthropathy

Intervention

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

Locations

Country	Name	City	State
France	Service de Rhumatologie - Hôpital Edouard Herriot	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscular strength	Muscular strength is the first outcome to evaluate sarcopenia	At day 1
Primary	Walking speed	Walking speed is a physical performance outcome, that is the second outcome to evaluate sarcopenia	At day 1
Primary	Muscular mass	Muscular mass is the third outcome to evaluate sarcopenia and will be assessed using DXA	Up to 4 month after inclusion
Secondary	Alcohol consumption		At day 1
Secondary	Tobacco consumption		At day 1
Secondary	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
Secondary	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
Secondary	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
Secondary	Score at the SARQOL questionnaire	Quality of life will be assessed thanks to the SARQOL questionnaire (score between 0 and 100)	At day 1