Video Coaching of Physical Activity in Axial Spondyloarthritis

NCT03965650 | Unknown

• 2 other identifiers: APHP1906222019-A01384-53
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 :

• 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.

Conditions

Axial Spondyloarthritis

Keywords

axial spondyloarthritis; online video coaching; physical activity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Ankylosing Spondylitis Disease Activity : (BASDAI) (PRO)

  at baseline, 3 months and 6 months

• Ankylosing Spondylitis Disease Activity : (ASDAS CRP) (PRO)

  at baseline, 3 months and 6 months

• Bath Ankylosing Spondylitis Functional Index (BASFI) (PRO)

  at baseline, 3 months and 6 months

• Fatigue (PRO)

  at baseline, 3 months and 6 months

• Health assessment: HAQ-S (PRO)

  at baseline, 3 months and 6 months

Study Arms (2)

Intervention group: video coaching exercises

EXPERIMENTAL

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

Control group: routine exercises

ACTIVE COMPARATOR

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

Interventions

Video coaching exercises OTHER

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

Intervention group: video coaching exercises

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.

Control group: routine exercises

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Patient equipped with an internet access;
• Medical certificate of proposed physical activities.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service de rhumatologie, Hôpital Ambroise Paré

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

RECRUITING

MeSH Terms

Conditions

Axial Spondyloarthritis; Motor Activity

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Behavior

Study Officials

• Patrick Le Goux, MD

  Service de rhumatologie, Hôpital Ambroise Paré

  PRINCIPAL INVESTIGATOR

• Gilles Hayem, MD

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

  STUDY DIRECTOR

Central Study Contacts

Patrick Le Goux, MD

CONTACT

+ 33 1 49 09 56 84; patrick.legoux@aphp.fr

Gilles Hayem, MD

CONTACT

+ 33 1 49 09 53 07; ghayem@hpsj.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: May 29, 2019
• Study Start: February 24, 2022
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: March 16, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)