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Active, Not Recruiting

NCT Number: NCT03965650

Video Coaching of Physical Activity in Axial Spondyloarthritis

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de rhumatologie, Hôpital Ambroise Paré

Boulogne-Billancourt, Hauts-de-Seine, 92100, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Video coaching exercises

Other

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

Routine exercises

Other

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.

Primary outcomes

  1. Proportion of patients responding to the "ASAS 20" criterion at 3 months

    Time frame: 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).

Secondary outcomes

  1. Ankylosing Spondylitis Disease Activity : (BASDAI) (PRO)

    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.

  2. Ankylosing Spondylitis Disease Activity : (ASDAS CRP) (PRO)

    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.

  3. Bath Ankylosing Spondylitis Functional Index (BASFI) (PRO)

    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.

  4. Fatigue (PRO)

    Time frame: at baseline, 3 months and 6 months

    Fatigue will be assessed with a Visual Analogue Scale

  5. Health assessment: HAQ-S (PRO)

    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)

  6. SPA impact on general health: ASAS-HI (PRO)

    Time frame: at baseline, 3 months and 6 months

    General health will be assessed with the ASAS Health Index auto-questionnaire

  7. Work Productivity and Activity : WPAI (PRO)

    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

  8. Sleep quality: PSQI

    Time frame: at baseline, 3 months and 6 months

    Sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI) auto-questionnaire

  9. Physical activity: IPAQ (PRO)

    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

  10. Analgesic and anti-inflammatory drug intake

    Time frame: at 3 months and 6 months

    Following drugs intake will be collected:

    • non-steroidal anti-inflammatory drugs (NSAIDs)
    • corticosteroids
  11. Anthropometric measures: BASMI

    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)

  12. Anthropometric measures: Enthesitis: MASES

    Time frame: at baseline, 3 months and 6 months

    Entesis involvement will be assessed with the Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)

  13. Anthropometric measures: Muscle strength: dynamometer

    Time frame: at baseline, 3 months and 6 months

    Muscle strength of the upper and lower limbs will be assessed with a dynamometer

  14. Anthropometric measures: 6-minutes walk test

    Time frame: at baseline, 3 months and 6 months

    Walking ability will be assessed with the 6-minutes walking test.

  15. Anthropometric measures: Body mass index (BMI)

    Time frame: at baseline, 3 months and 6 months

    Weight, height and waist size will be collected to calculate the BMI of patients.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Randomized Controlled Study of a Video Coaching Program of Physical Activity in Patients Suffering From Axial Spondyloarthritis

Acronym: SatiSpAction

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
May 29, 2019
Registry last updated
Jul 16, 2026

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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