Sarcopenia in Axial and Peripheral Spondyloarthropathies (SASPAR)
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|ClinicalTrials.gov Identifier: NCT03319264|
Recruitment Status : Completed
First Posted : October 24, 2017
Last Update Posted : September 7, 2018
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||106 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Patients with SpA
Patients included in this single group study will have 3 interventions to assess the severity of muscle loss :
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
- Muscular strength [ Time Frame: At day 1 ]Muscular strength is the first outcome to evaluate sarcopenia
- Walking speed [ Time Frame: At day 1 ]Walking speed is a physical performance outcome, that is the second outcome to evaluate sarcopenia
- 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
- Alcohol consumption [ Time Frame: At day 1 ]
- Tobacco consumption [ Time Frame: At day 1 ]
- 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.
- 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.
- 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.
- 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)
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
|Service de Rhumatologie - Hôpital Edouard Herriot|
|Lyon, France, 69003|