Video Coaching of Physical Activity in Axial Spondyloarthritis

NCT ID: NCT03965650

Last Updated: 2023-03-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-24
• Study Completion Date: 2024-02-29

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).

Conditions

Axial Spondyloarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Video coaching exercises

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

Routine exercises

Intervention Type: 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.

Interventions

Video coaching exercises

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

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick Le Goux, MD

Role: PRINCIPAL_INVESTIGATOR

Service de rhumatologie, Hôpital Ambroise Paré

Gilles Hayem, MD

Role: STUDY_DIRECTOR

Service de rhumatologie, Hôpital Saint Joseph, 185 Rue Raymond Losserand 75014 Paris

Locations

Service de rhumatologie, Hôpital Ambroise Paré

Boulogne-Billancourt, Hauts-de-Seine, France

Site Status: RECRUITING

Countries

France

Central Contacts

Patrick Le Goux, MD

Role: CONTACT

patrick.legoux@aphp.fr

+ 33 1 49 09 56 84

Gilles Hayem, MD

Role: CONTACT

ghayem@hpsj.fr

+ 33 1 49 09 53 07

Facility Contacts

Patrick Le Goux, MD

Role: primary

patrick.legoux@aphp.fr

+ 33 1 49 09 56 84

Gilles Hayem, MD

Role: backup

gilles.hayem@aphp.fr

+ 33 1 49 09 53 07

Other Identifiers

2019-A01384-53

Identifier Type: REGISTRY

Identifier Source: secondary_id

APHP190622

Identifier Type: -

Identifier Source: org_study_id