Ireland
--:--IST
Active, not recruiting Not applicable

Video Coaching of Physical Activity in Axial Spondyloarthritis

NCT03965650 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2022-02-24
Last updated
2026-07-16

Condition(s) studied

Axial Spondyloarthritis

Investigational drug(s) / intervention(s)

Video coaching exercisesRoutine exercises

Video coaching exercises: Patients will perform physical exercises following a specifical video coaching program during 6 months.

Routine exercises: 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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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 outcome measure(s)

  • Proportion of patients responding to the "ASAS 20" criterion at 3 months — at 3 months
    The primary outcome measure will be the proportion of patients simultaneously satisfying both criteria : * at least 20% improvement * improvement of at least 10 points on visual analog scale in the following domains: overall evaluation by the patient, visual analog scale (pain scale), Bath Ankylosing Spondylitis Functional Index (BASFI), and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI).

Trial sites (1)

FacilityCityRegionStatus
Service de rhumatologie, Hôpital Ambroise Paré Boulogne-Billancourt Hauts-de-Seine
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03965650 on ClinicalTrials.gov ↗ ← All trials in France