High-intensity Training in Patients With Spondyloarthritis: a Randomized Controlled Trial

NCT05781763 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-03-23

No results posted yet for this study

Summary

Project summary

Background: For people diagnosed with a spondyloarthritis (SpA) e.g. ankylosing spondylitis or undifferentiated spondyloarthritis, physical activity and exercise are important components in the self-management. Exercise, in addition to physical and mental symptoms related to the disease can easily feel overwhelming to exercise, and low adherence may result. By studying the effects of high-intensity interval training (HIIT) in comparison with training as usual on physiological, inflammatory, and self-reported disease parameters in patients with SpA, we intend to further investigate the short-term and longitudinal training effects, and refine the knowledge to tailor, coach, and stimulate to self-performed HIIT.

Objective: The purpose of this study is to investigate the short- and long-term effects of high- intensity interval training (HIIT) on physiological, inflammatory, and self-reported health parameters in patients with SpA. The aim is also to study the adherence to physical activity and exercise recommendations.

Design: A randomized controlled trial (RCT) design. Participants: One hundred adults with a confirmed axial SpA from rheumatology clinics in southern Sweden will be recruited and randomized into two groups, the intervention group and the control group.

Intervention: Three high-intensity training sessions per week for three months, of which two interval sessions, with coaching both from a clinical physiotherapist and digital devices (watch and app) followed by nine months with sporadic coaching. The control group will go on with exercise as usual.

Primary outcome: Self-reported disease activity, inflammatory biomarkers (acute phase proteins).

Secondary outcomes: Physical fitness (aerobic capacity (VO2max), blood pressure, grep strength), body composition and self-reported physical function, health status, well-being, pain, fatigue, adherence to physical activity and exercise recommendations, and confidence in one's own ability to manage pain, symptoms and high-intensity exercise, and additional serum biomarkers.

Conditions

  • Axial Spondyloarthritis

Interventions

BEHAVIORAL

High intensity interval training (HIIT)

2 HIIT sessions/week in self-selected activity and type of interval-session with in total 15 minutes interval time (85-90% of MHR) with active rest (50-70% of MHR) between intervals for 12 weeks 1 self-selected session at moderate or high-intensity/week for 12 weeks Standardized physical and digital coaching by a physiotherapist

OTHER

Control group

Continuing with exercise as usual during 12 months

Sponsors & Collaborators

  • Halmstad University

    lead OTHER

Principal Investigators

  • Haglund, Assoc. prof. · Dept. of Environmental and Biosciences, Halmstad University, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
67 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-21
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Sweden

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 NCT05781763 on ClinicalTrials.gov