Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-24 @ 5:17 PM
Study NCT ID:
NCT03965650
Status:
UNKNOWN
Last Update Posted:
2023-03-16
First Post:
2019-05-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Video Coaching of Physical Activity in Axial Spondyloarthritis
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Randomized Controlled Study of a Video Coaching Program of Physical Activity in Patients Suffering From Axial Spondyloarthritis
Status:
UNKNOWN
Status Verified Date:
2023-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SatiSpAction
Brief Summary:
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.
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.
Detailed Description:
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:
* reduction of the intrinsic inflammatory activity of the rheumatic disease;
* improvement of the global physical condition: muscular strength and resistance, walking ability, chest expansion;
* reduction of fatigue and improvement of sleeping;
* reduction of consumption of symptomatic drug (analgesics, NSAIDs, corticosteroids).
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:
* reduction of the intrinsic inflammatory activity of the rheumatic disease;
* improvement of the global physical condition: muscular strength and resistance, walking ability, chest expansion;
* reduction of fatigue and improvement of sleeping;
* reduction of consumption of symptomatic drug (analgesics, NSAIDs, corticosteroids).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2019-A01384-53 | REGISTRY | IDRCB | View |