A Digital Exercise Intervention in Patients With Spondyloarthritis

NCT06462937 | Recruiting

• 1 other identifier: DS00735
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

This protocol describes a 6-month randomised, controlled exercise trial in patients with axial spondyloarthritis (axSpA) with re-randomization after 3-months. The primary outcome of the trial (disease activity) will be evaluated at 3-months. The exercise programme on trial comprises high intensity interval training (HIIT), muscular strength exercise and aerobic physical activity sessions of specified duration, frequency, and intensity. It also includes brief knowledge videos to empower the patient. The intervention is remotely delivered by the SPARK application with personalised follow-up including monitoring to ensure exercise progression and adherence to exercise intensity. The SPARK application is built on a platform delivered by ABEL Technologies (trademark) and is customised for patients with axSpA.

Conditions

Spondyloarthritis; Exercise

Keywords

Remote; Digital; High intensity interval training

Outcome Measures

Primary Outcomes (1)

• Disease activity 3 months

  Number of participants in ASDAS inactive (ASDAS \< 1.3) at 3 months

  3 months

Secondary Outcomes (24)

• Biologic disease modifying anti-rheumatic drugs 3 months

  3 months

• Disease activity 6 months

  6 months

• Proportion of participants using non-steroidal anti-inflammatory drugs

  3 and 6 months

• Bath ankylosing spondylitis metrology index

  3 and 6 months

• Bath ankylosing spondylitis function index

  3 and 6 months

Study Arms (4)

Exercise with personal supervision 0-3 months

EXPERIMENTAL

Exercise

Behavioral: Exercise with supervision

Control 0-3 months

NO INTERVENTION

Usual care

Exercise with personal supervision 3-6 months

EXPERIMENTAL

Exercise

Behavioral: Exercise with supervision

Exercise without personal supervision 3-6 months

ACTIVE COMPARATOR

Exercise

Behavioral: Exercise without supervision

Interventions

Exercise with supervision BEHAVIORAL

Remote exercise will be administered with digital supervision. The Exercise group will receive a personalised program with individual adaptations aiming to perform 3 exercise sessions per week including HIIT, strength exercise and moderate intensive aerobic exercise. Participants will consult their rheumatologist parallel to the SPARK trial.

Exercise with personal supervision 0-3 months; Exercise with personal supervision 3-6 months

Exercise without supervision BEHAVIORAL

Remote exercise will be administered without digital supervision. Participants will receive a standard exercise program fulfilling the exercise protocol requirements, the exercise program will progress. But there will be no direct contact between the participant and the coach. Participants will consult their rheumatologist parallel to the SPARK trial.

Exercise without personal supervision 3-6 months

Eligibility Criteria

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

You may qualify if:

• axSpA diagnosis within the last two years by a rheumatologist according to the ASAS criteria of 2009
• active disease (ASDAS \> 1.3)

You may not qualify if:

• Active uveitis.
• CRP \> 30.
• Former or current use of bDMARDs.
• Absolute and relative contradictions to high intensity exercise according to the American College of Sports Medicine (ACSM)
• Other serious disease such as cancer.
• Patients incapable to follow the protocol or the control set-up with remote monitoring.

Sponsors & Collaborators

• Diakonhjemmet Hospital: lead

Study Sites (1)

Diakonhjemmet hospital

Oslo, Norway

RECRUITING

MeSH Terms

Conditions

Spondylarthritis; Motor Activity

Interventions

Exercise; Organization and Administration

Condition Hierarchy (Ancestors)

Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services Administration

Central Study Contacts

Sella A Provan, Professor

CONTACT

4791582581; SellaProvan@gmail.com

Birgitte Nellemann, PhD

CONTACT

4747957020; birgittenellemann@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The randomization is performed by a study personnel not involved in data collection. Patients are asked not to inform their care-giver or the physiotherapist who perform the study tests which group the patient is allocated to.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Baseline: randomization to intervention (Exercise) or control (Usual care) 1:1. 3 months: randomization to intervention (Exercise remotely delivered plan with personalised weekly follow-up) or control (Exercise remotely delivered plan without weekly follow-up)

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: June 17, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2030
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)