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出境医 / 临床实验 / Video Coaching of Physical Activity in Axial Spondyloarthritis (SATISPACTION)

Video Coaching of Physical Activity in Axial Spondyloarthritis (SATISPACTION)

Study Description
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.

Condition or disease Intervention/treatment Phase
Axial Spondyloarthritis Other: Video coaching exercises Other: Routine exercises Not Applicable

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).
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Study of a Video Coaching Program of Physical Activity in Patients Suffering From Axial Spondyloarthritis
Estimated Study Start Date : May 2021
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Intervention group: video coaching exercises
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.
Other: Video coaching exercises
Patients will perform physical exercises following a specifical video coaching program during 6 months.

Active Comparator: Control group: routine exercises
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.
Other: 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.


Outcome Measures
Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Patrick Le Goux, MD + 33 1 49 09 56 84 patrick.legoux@aphp.fr
Contact: Gilles Hayem, MD + 33 1 49 09 53 07 gilles.hayem@aphp.fr

Locations
Layout table for location information
France
Service de rhumatologie, Hôpital Ambroise Paré
Boulogne-Billancourt, Hauts-de-Seine, France, 92100
Contact: Patrick Le Goux, MD    + 33 1 49 09 56 84    patrick.legoux@aphp.fr   
Contact: Gilles Hayem, MD    + 33 1 49 09 53 07    gilles.hayem@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Layout table for investigator information
Principal Investigator: Patrick Le Goux, MD Service de rhumatologie, Hôpital Ambroise Paré
Study Director: Gilles Hayem, MD Service de rhumatologie, Hôpital Ambroise Paré
Tracking Information
First Submitted Date  ICMJE May 24, 2019
First Posted Date  ICMJE May 29, 2019
Last Update Posted Date February 25, 2021
Estimated Study Start Date  ICMJE May 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2019)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2019)
  • 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.
  • 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.
  • 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.
  • Fatigue (PRO) [ Time Frame: at baseline, 3 months and 6 months ]
    Fatigue will be assessed with a Visual Analogue Scale
  • 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)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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)
  • 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)
  • 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
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Video Coaching of Physical Activity in Axial Spondyloarthritis
Official Title  ICMJE Randomized Controlled Study of a Video Coaching Program of Physical Activity in Patients Suffering From Axial Spondyloarthritis
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Axial Spondyloarthritis
Intervention  ICMJE
  • Other: Video coaching exercises
    Patients will perform physical exercises following a specifical video coaching program during 6 months.
  • Other: 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 Arms  ICMJE
  • Experimental: Intervention group: video coaching exercises
    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.
    Intervention: Other: Video coaching exercises
  • Active Comparator: Control group: routine exercises
    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.
    Intervention: Other: Routine exercises
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 24, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Patrick Le Goux, MD + 33 1 49 09 56 84 patrick.legoux@aphp.fr
Contact: Gilles Hayem, MD + 33 1 49 09 53 07 gilles.hayem@aphp.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03965650
Other Study ID Numbers  ICMJE 17PLX-SATISPACTION
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Patrick Le Goux, MD Service de rhumatologie, Hôpital Ambroise Paré
Study Director: Gilles Hayem, MD Service de rhumatologie, Hôpital Ambroise Paré
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP