Video Coaching of Physical Activity in Axial Spondyloarthritis (SatiSpAction)
Primary Purpose
Axial Spondyloarthritis
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Video coaching exercises
Routine exercises
Sponsored by
About this trial
This is an interventional treatment trial for Axial Spondyloarthritis focused on measuring axial spondyloarthritis, online video coaching, physical activity
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.
Sites / Locations
- Service de rhumatologie, Hôpital Ambroise ParéRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group: video coaching exercises
Control group: routine exercises
Arm 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.
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.
Outcomes
Primary Outcome Measures
Proportion of patients responding to the "ASAS 20" criterion 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
Ankylosing Spondylitis Disease Activity : (BASDAI) (PRO)
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)
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)
Data collected with the Bath Ankylosing Spondylitis Functional Index (BASFI) auto-questionnaire assessing the functional impact of disease.
Fatigue (PRO)
Fatigue will be assessed with a Visual Analogue Scale
Health assessment: HAQ-S (PRO)
SpA-related health will be assessed with the Health Assessment Questionnaire for the Spondyloarthropathies (HAQ-S)
SPA impact on general health: ASAS-HI (PRO)
General health will be assessed with the ASAS Health Index auto-questionnaire
Work Productivity and Activity : WPAI (PRO)
Work Productivity and Activity will be assessed with the Work Productivity and Activity Impairment (WPAI) auto-questionnaire
Sleep quality: PSQI
Sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI) auto-questionnaire
Physical activity: IPAQ (PRO)
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
Following drugs intake will be collected:
non-steroidal anti-inflammatory drugs (NSAIDs)
corticosteroids
Anthropometric measures: BASMI
The functional impact of SpA will be assessed with the Bath Ankylosing Spondylitis Metrology Index (BASMI)
Anthropometric measures: Enthesitis: MASES
Entesis involvement will be assessed with the Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
Anthropometric measures: Muscle strength: dynamometer
Muscle strength of the upper and lower limbs will be assessed with a dynamometer
Anthropometric measures: 6-minutes walk test
Walking ability will be assessed with the 6-minutes walking test.
Anthropometric measures: Body mass index (BMI)
Weight, height and waist size will be collected to calculate the BMI of patients.
Full Information
NCT ID
NCT03965650
First Posted
May 24, 2019
Last Updated
March 15, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT03965650
Brief Title
Video Coaching of Physical Activity in Axial Spondyloarthritis
Acronym
SatiSpAction
Official Title
Randomized Controlled Study of a Video Coaching Program of Physical Activity in Patients Suffering From Axial Spondyloarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 24, 2022 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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 :
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Axial Spondyloarthritis
Keywords
axial spondyloarthritis, online video coaching, physical activity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group: video coaching exercises
Arm Type
Experimental
Arm 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.
Arm Title
Control group: routine exercises
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Video coaching exercises
Intervention Description
Patients will perform physical exercises following a specifical video coaching program during 6 months.
Intervention Type
Other
Intervention Name(s)
Routine exercises
Intervention Description
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 Outcome Measure Information:
Title
Proportion of patients responding to the "ASAS 20" criterion at 3 months
Description
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).
Time Frame
at 3 months
Secondary Outcome Measure Information:
Title
Ankylosing Spondylitis Disease Activity : (BASDAI) (PRO)
Description
Ankylosing Spondylitis Disease Activity will be assessed with the Bath Ankylosing Spondylitis Disease Activity (BASDAI) auto-questionnaire assessing the inflammatory activity of the disease.
Time Frame
at baseline, 3 months and 6 months
Title
Ankylosing Spondylitis Disease Activity : (ASDAS CRP) (PRO)
Description
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.
Time Frame
at baseline, 3 months and 6 months
Title
Bath Ankylosing Spondylitis Functional Index (BASFI) (PRO)
Description
Data collected with the Bath Ankylosing Spondylitis Functional Index (BASFI) auto-questionnaire assessing the functional impact of disease.
Time Frame
at baseline, 3 months and 6 months
Title
Fatigue (PRO)
Description
Fatigue will be assessed with a Visual Analogue Scale
Time Frame
at baseline, 3 months and 6 months
Title
Health assessment: HAQ-S (PRO)
Description
SpA-related health will be assessed with the Health Assessment Questionnaire for the Spondyloarthropathies (HAQ-S)
Time Frame
at baseline, 3 months and 6 months
Title
SPA impact on general health: ASAS-HI (PRO)
Description
General health will be assessed with the ASAS Health Index auto-questionnaire
Time Frame
at baseline, 3 months and 6 months
Title
Work Productivity and Activity : WPAI (PRO)
Description
Work Productivity and Activity will be assessed with the Work Productivity and Activity Impairment (WPAI) auto-questionnaire
Time Frame
at baseline, 3 months and 6 months
Title
Sleep quality: PSQI
Description
Sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI) auto-questionnaire
Time Frame
at baseline, 3 months and 6 months
Title
Physical activity: IPAQ (PRO)
Description
Physical activity will be assessed with the International Physical Activity Questionnaire (IPAQ) - Short Form and Long Form auto-questionnaires
Time Frame
at baseline, 3 months and 6 months
Title
Analgesic and anti-inflammatory drug intake
Description
Following drugs intake will be collected:
non-steroidal anti-inflammatory drugs (NSAIDs)
corticosteroids
Time Frame
at 3 months and 6 months
Title
Anthropometric measures: BASMI
Description
The functional impact of SpA will be assessed with the Bath Ankylosing Spondylitis Metrology Index (BASMI)
Time Frame
at baseline, 3 months and 6 months
Title
Anthropometric measures: Enthesitis: MASES
Description
Entesis involvement will be assessed with the Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
Time Frame
at baseline, 3 months and 6 months
Title
Anthropometric measures: Muscle strength: dynamometer
Description
Muscle strength of the upper and lower limbs will be assessed with a dynamometer
Time Frame
at baseline, 3 months and 6 months
Title
Anthropometric measures: 6-minutes walk test
Description
Walking ability will be assessed with the 6-minutes walking test.
Time Frame
at baseline, 3 months and 6 months
Title
Anthropometric measures: Body mass index (BMI)
Description
Weight, height and waist size will be collected to calculate the BMI of patients.
Time Frame
at baseline, 3 months and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick Le Goux, MD
Phone
+ 33 1 49 09 56 84
Email
patrick.legoux@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Gilles Hayem, MD
Phone
+ 33 1 49 09 53 07
Email
ghayem@hpsj.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Le Goux, MD
Organizational Affiliation
Service de rhumatologie, Hôpital Ambroise Paré
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gilles Hayem, MD
Organizational Affiliation
Service de rhumatologie, Hôpital Saint Joseph, 185 Rue Raymond Losserand 75014 Paris
Official's Role
Study Director
Facility Information:
Facility Name
Service de rhumatologie, Hôpital Ambroise Paré
City
Boulogne-Billancourt
State/Province
Hauts-de-Seine
ZIP/Postal Code
92100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Le Goux, MD
Phone
+ 33 1 49 09 56 84
Email
patrick.legoux@aphp.fr
First Name & Middle Initial & Last Name & Degree
Gilles Hayem, MD
Phone
+ 33 1 49 09 53 07
Email
gilles.hayem@aphp.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Video Coaching of Physical Activity in Axial Spondyloarthritis
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