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A Digital Exercise Intervention in Patients With Spondyloarthritis

NCT06462937 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2024-09-19

No results posted yet for this study

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

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

  • Diakonhjemmet Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2027-08-01
Completion
2030-08-01

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06462937 on ClinicalTrials.gov