Video Coaching of Physical Activity in Axial Spondyloarthritis (SatiSpAction)

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Axial Spondyloarthritis

Treatments: Other: Routine exercises; Other: Video coaching exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT03965650

APHP190622

2019-A01384-53 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient between 18 and 65 years;
• Patient can read and understand French;
• Signed informed consent form to participate in the study;
• Axial spondylarthritis according to ASAS criteria;
• Patient with a BASDAI score between 2.5 and 5;
• No change of biotherapy anti-TNF or anti-IL17 during the 3 months preceding the inclusion;
• Patient equipped with an internet access;
• Medical certificate of proposed physical activities.

Exclusion criteria

• All diseases (cardiovascular disease or chronic neurological disease or others) contraindicating the requested exercises according to physician;
• Axial spondyloarthritis in remission defined by a BASDAI < 2.5/10 or in excessive inflammatory activity, defined by BASDAI > 5/10;
• Pregnant woman (positive pregnant test) or woman try to conceive in following 6 months;
• Patient with articular prosthesis;
• Patient who already participate in a specific exercise program or practice a sport (including Yoga or Tai Chi) more than one hour per week;
• Severe obesity ( BMI > 35);
• Patient without health insurance;
• Patient legally unable.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Intervention group: video coaching exercises

Experimental group

Description:

Video coaching exercises group: patients will perform physical exercises according to a video coaching program 3 times weekly during 6 months. The on-line program has been designed especially for this study.

Treatment:

Other: Video coaching exercises

Control group: routine exercises

Active Comparator group

Description:

Routine method advising and encouraging patients to perform physical activities according to the WHO recommendations during 3 months then to follow the video coaching physical exercises program during 3 months.

Treatment:

Other: Routine exercises