A Digital Exercise Intervention in Patients With Spondyloarthritis
NCT ID: NCT06462937
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
260 participants
INTERVENTIONAL
2024-07-01
2030-08-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
High-intensity Training in Patients With Spondyloarthritis: a Randomized Controlled Trial
NCT05781763
The Effect of Exercise on Disease Activity and Cardiovascular Risk for Patients With Axial SpondyloArthritis
NCT02356874
A Post-Marketing-Observational Study (PMOS) to Determine the Effectiveness of Combined Adalimumab Treatment and Active Supervised Training in Patients With Axial Spondyloarthritis (axSpA)
NCT03258814
Effect of Exercise on Disease Activity and Cardiovascular Risk Factors in Patients With Ankylosing Spondylitis
NCT01436942
Effects of a Digital Exercise Intervention on Sleep and Physical Activity in Patients With Spondyloarthritis
NCT07034404
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Main inclusion criteria Adults (\> 18 years) with clinical diagnosis from a rheumatologist of axSpA within the last 2 years of inclusion also fulfilling the ankylosing spondylitis disease activity score (ASAS) classification criteria, who are biologic disease modifying anti-rheumatic drugs (bDMARD) naïve, and have an active disease (ASDAS ≥ 1.3)
Main exclusion criteria:
Active iridocyclitis, c-reactive protein (CRP) \> 30, contraindication to high intensity interval training
Primary outcome Proportion of participants in ASDAS inactive (ASDAS \< 1.3) at 3 months
Number of participants: 260 (with an anticipated drop-out rate of 15%)
Study design: A two-arm multi-centre, clinical trial, randomization 1:1 to either digital exercise intervention with remote follow-up or usual care.
Intervention: Exercise delivered through an application and with personalised follow-up by a coach through remote sessions (the participant and SPARK-coach are not at the same physical location) weekly. The exercise is progressively tailored to the fitness level of each participant. The program consists of 5 session per week on 3 different days including: two sessions with HIIT, 2 sessions with strength exercise, and one session with an aerobic exercise at moderate intensity. Goal for HIIT is 10 minutes two times per week at 85-95% of maximal heart rate (20 minutes in total). The exercise will be performed at a location of the participants' choice and data will be logged by a sports watch.
Efficacy assessments: ASDAS disease activity measure (4 patient reported questions and measure of CRP), Bath ankylosing spondylitis disease activity index (BASDAI).
Physical measure: cardiorespiratory fitness, in a subset of participants direct cardiopulmonary testing, muscular strength tests.
Psychological measures: Warwick and Edinburgh mental wellbeing scale (WEMWBS), EuroQol (EQ5D).
Medication: use of bDMARDs, use of NSAID
Safety assessments General physical examination and vital signs, laboratory tests as a part of usual clinical care, record of adverse events and serious adverse events, magnetic resonance imaging (MRI).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
3 months: randomization to intervention (Exercise remotely delivered plan with personalised weekly follow-up) or control (Exercise remotely delivered plan without weekly follow-up)
SUPPORTIVE_CARE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Exercise with personal supervision 0-3 months
Exercise
Exercise with supervision
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.
Control 0-3 months
Usual care
No interventions assigned to this group
Exercise with personal supervision 3-6 months
Exercise
Exercise with supervision
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 without personal supervision 3-6 months
Exercise
Exercise without supervision
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Exercise with supervision
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 without supervision
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* active disease (ASDAS \> 1.3)
Exclusion Criteria
* CRP \> 30.
* Former or current use of bDMARDs.
* Pregnancy or planned pregnancy within 6 months from inclusion.
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Diakonhjemmet Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Diakonhjemmet hospital
Oslo, , Norway
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Birgitte Nellemann
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DS00735
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.