Clinical trial NCT03965650: Video Coaching of Physical Activity in Axial Spondyloarthritis
Official title: Randomized Controlled Study of a Video Coaching Program of Physical Activity in Patients Suffering From Axial Spondyloarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Axial Spondyloarthritis
Keywords: axial spondyloarthritis
online video coaching
physical activity
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-05-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients responding to the "ASAS 20" criterion at 3 months
timeFrame: at 3 months
Secondary outcomes:
measure: Ankylosing Spondylitis Disease Activity : (BASDAI) (PRO)
timeFrame: at baseline, 3 months and 6 months
measure: Ankylosing Spondylitis Disease Activity : (ASDAS CRP) (PRO)
timeFrame: at baseline, 3 months and 6 months
measure: Bath Ankylosing Spondylitis Functional Index (BASFI) (PRO)
timeFrame: at baseline, 3 months and 6 months
measure: Fatigue (PRO)
timeFrame: at baseline, 3 months and 6 months
measure: Health assessment: HAQ-S (PRO)
timeFrame: at baseline, 3 months and 6 months
measure: SPA impact on general health: ASAS-HI (PRO)
timeFrame: at baseline, 3 months and 6 months
measure: Work Productivity and Activity : WPAI (PRO)
timeFrame: at baseline, 3 months and 6 months
measure: Sleep quality: PSQI
timeFrame: at baseline, 3 months and 6 months
measure: Physical activity: IPAQ (PRO)
timeFrame: at baseline, 3 months and 6 months
measure: Analgesic and anti-inflammatory drug intake
timeFrame: at 3 months and 6 months
measure: Anthropometric measures: BASMI
timeFrame: at baseline, 3 months and 6 months
measure: Anthropometric measures: Enthesitis: MASES
timeFrame: at baseline, 3 months and 6 months
measure: Anthropometric measures: Muscle strength: dynamometer
timeFrame: at baseline, 3 months and 6 months
measure: Anthropometric measures: 6-minutes walk test
timeFrame: at baseline, 3 months and 6 months
measure: Anthropometric measures: Body mass index (BMI)
timeFrame: at baseline, 3 months and 6 months
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: Service de rhumatologie, Hôpital Ambroise Paré
state: Hauts-de-Seine
Study officials:
affiliation: Service de rhumatologie, Hôpital Ambroise Paré
name: Patrick Le Goux, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Service de rhumatologie, Hôpital Saint Joseph, 185 Rue Raymond Losserand 75014 Paris
name: Gilles Hayem, MD
role: STUDY_DIRECTOR
References: