Service de rhumatologie, Hôpital Ambroise Paré
Boulogne-Billancourt, Hauts-de-Seine, 92100, France
NCT Number: NCT03965650
The primary objective of the study is to demonstrate the beneficial effect of a 3 months home-based physical exercise program supervised by online videos, in addition to the usual recommendations, in comparison with usual physical activity as recommended by the WHO.
The secondary objectives of the study are :
1. to compare the following criteria between 2 groups at 3 and 6 months:
* quality of life; * other measures of disease activity ; * sleep quality ; * walking ability * muscle strength of; * professional activity; * cost of cares; * evolution of weight, BMI and waist. 2. to evaluate the observance of physical activity program and its tolerance at 3 and 6 months.
This study is active but is not currently recruiting participants.
18 year–65 year
All sexes
Interventional
Not applicable
Boulogne-Billancourt, Hauts-de-Seine, 92100, France
The spondyloarthritides are a group of inflammatory rheumatic diseases, including ankylosing spondylitis, reactive arthritis, inflammatory bowel disease-related rheumatic disease, and psoriatic arthritis.
The frequence of axial spondyloarthritis is 0.41% in the french population. This disease is associated with a reduction of physical capacities and quality of life. NSAIDs or even biologic therapies do not always permit a sufficient control of the disease. Different physical exercise programs can be effective as an additional therapy for spondyloarthritis, with positive effects on spinal mobility as well as main disease activity and functional indices (BASDAI, BASFI and BASMI). The severity of the disease does not seem to influence significantly the patients' motivation in practicing physical activity.
This proposed study aims to demonstrate the beneficial effect of physical exercises coached with a specific internet program diffused on a secured platform.
Each patient will have to connect 3 times weekly in order to follow the entire program.
The impact will be evaluated at 3 months and 6 months.
Potential impacts of video-coaching program are:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will perform physical exercises following a specifical video coaching program during 6 months.
Routine method by advising and encouraging patients to perform exercises according to the WHO recommendations during the first 3 months of the study.
Thereafter, patients will have access to the video coaching program of physical activities during the following 3 months.
Time frame: at 3 months
The primary outcome measure will be the proportion of patients simultaneously satisfying both criteria :
Time frame: at baseline, 3 months and 6 months
Ankylosing Spondylitis Disease Activity will be assessed with the Bath Ankylosing Spondylitis Disease Activity (BASDAI) auto-questionnaire assessing the inflammatory activity of the disease.
Time frame: at baseline, 3 months and 6 months
Ankylosing Spondylitis Disease Activity will be assessed with the Ankylosing Spondylitis Disease Activity Score (ASDAS CRP) auto-questionnaire assessing the inflammatory activity of the disease.
Time frame: at baseline, 3 months and 6 months
Data collected with the Bath Ankylosing Spondylitis Functional Index (BASFI) auto-questionnaire assessing the functional impact of disease.
Time frame: at baseline, 3 months and 6 months
Fatigue will be assessed with a Visual Analogue Scale
Time frame: at baseline, 3 months and 6 months
SpA-related health will be assessed with the Health Assessment Questionnaire for the Spondyloarthropathies (HAQ-S)
Time frame: at baseline, 3 months and 6 months
General health will be assessed with the ASAS Health Index auto-questionnaire
Time frame: at baseline, 3 months and 6 months
Work Productivity and Activity will be assessed with the Work Productivity and Activity Impairment (WPAI) auto-questionnaire
Time frame: at baseline, 3 months and 6 months
Sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI) auto-questionnaire
Time frame: at baseline, 3 months and 6 months
Physical activity will be assessed with the International Physical Activity Questionnaire (IPAQ) - Short Form and Long Form auto-questionnaires
Time frame: at 3 months and 6 months
Following drugs intake will be collected:
Time frame: at baseline, 3 months and 6 months
The functional impact of SpA will be assessed with the Bath Ankylosing Spondylitis Metrology Index (BASMI)
Time frame: at baseline, 3 months and 6 months
Entesis involvement will be assessed with the Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
Time frame: at baseline, 3 months and 6 months
Muscle strength of the upper and lower limbs will be assessed with a dynamometer
Time frame: at baseline, 3 months and 6 months
Walking ability will be assessed with the 6-minutes walking test.
Time frame: at baseline, 3 months and 6 months
Weight, height and waist size will be collected to calculate the BMI of patients.
Assistance Publique - Hôpitaux de Paris
Other
Randomized Controlled Study of a Video Coaching Program of Physical Activity in Patients Suffering From Axial Spondyloarthritis
Acronym: SatiSpAction
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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