Video Coaching of Physical Activity in Axial Spondyloarthritis (SatiSpAction)

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

Study Overview

• Status: Recruiting
• Conditions: Axial Spondyloarthritis
• Intervention / Treatment: Other: Video coaching exercises; Other: Routine exercises

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: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patrick Le Goux, MD; Phone Number: + 33 1 49 09 56 84; Email: patrick.legoux@aphp.fr
• Study Contact Backup: Name: Gilles Hayem, MD; Phone Number: + 33 1 49 09 53 07; Email: ghayem@hpsj.fr

Study Locations

• France
  • Hauts-de-Seine
    • Boulogne-Billancourt, Hauts-de-Seine, France, 92100
      • Recruiting
      • Service de rhumatologie, Hôpital Ambroise Paré
      • Contact: Patrick Le Goux, MD; Phone Number: + 33 1 49 09 56 84; Email: patrick.legoux@aphp.fr
      • Contact: Gilles Hayem, MD; Phone Number: + 33 1 49 09 53 07; Email: gilles.hayem@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	at 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at baseline, 3 months and 6 months
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.	at baseline, 3 months and 6 months
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.	at baseline, 3 months and 6 months
Fatigue (PRO)	Fatigue will be assessed with a Visual Analogue Scale	at baseline, 3 months and 6 months
Health assessment: HAQ-S (PRO)	SpA-related health will be assessed with the Health Assessment Questionnaire for the Spondyloarthropathies (HAQ-S)	at baseline, 3 months and 6 months
SPA impact on general health: ASAS-HI (PRO)	General health will be assessed with the ASAS Health Index auto-questionnaire	at baseline, 3 months and 6 months
Work Productivity and Activity : WPAI (PRO)	Work Productivity and Activity will be assessed with the Work Productivity and Activity Impairment (WPAI) auto-questionnaire	at baseline, 3 months and 6 months
Sleep quality: PSQI	Sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI) auto-questionnaire	at baseline, 3 months and 6 months
Physical activity: IPAQ (PRO)	Physical activity will be assessed with the International Physical Activity Questionnaire (IPAQ) - Short Form and Long Form auto-questionnaires	at baseline, 3 months and 6 months
Analgesic and anti-inflammatory drug intake	Following drugs intake will be collected: non-steroidal anti-inflammatory drugs (NSAIDs); corticosteroids	at 3 months and 6 months
Anthropometric measures: BASMI	The functional impact of SpA will be assessed with the Bath Ankylosing Spondylitis Metrology Index (BASMI)	at baseline, 3 months and 6 months
Anthropometric measures: Enthesitis: MASES	Entesis involvement will be assessed with the Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)	at baseline, 3 months and 6 months
Anthropometric measures: Muscle strength: dynamometer	Muscle strength of the upper and lower limbs will be assessed with a dynamometer	at baseline, 3 months and 6 months
Anthropometric measures: 6-minutes walk test	Walking ability will be assessed with the 6-minutes walking test.	at baseline, 3 months and 6 months
Anthropometric measures: Body mass index (BMI)	Weight, height and waist size will be collected to calculate the BMI of patients.	at baseline, 3 months and 6 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Patrick Le Goux, MD, Service de rhumatologie, Hôpital Ambroise Paré; Study Director: Gilles Hayem, MD, Service de rhumatologie, Hôpital Saint Joseph, 185 Rue Raymond Losserand 75014 Paris

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2022
• Primary Completion (Anticipated): February 1, 2024
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: May 24, 2019
• First Submitted That Met QC Criteria: May 24, 2019
• First Posted (Actual): May 29, 2019

Study Record Updates

• Last Update Posted (Actual): March 16, 2023
• Last Update Submitted That Met QC Criteria: March 15, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: physical activity; axial spondyloarthritis; online video coaching
• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Bone Diseases, Infectious; Spondylitis; Spondylarthritis
• Other Study ID Numbers: APHP190622; 2019-A01384-53 (Registry Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No