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

NCT05781763 | Recruiting

• 1 other identifier: 350974
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (10)

• Self-reported disease activity BASDAI

  The disease-specific Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) based on six questions on fatigue, pain, tenderness, and morning stiffness measured with numeric questions (range 0-10). The final score is estimated by calculating the mean score 0-10 (best-worse)

  after 3 months

• Self-reported disease activity BASDAI

  The disease-specific Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) based on six questions on fatigue, pain, tenderness, and morning stiffness measured with numeric questions (range 0-10). The final score is estimated by calculating the mean score 0-10 (best-worse)

  after 12 months

• Self-reported disease activity ASDAS-CRP

  Ankylosing Spondylitis Disease Activity Score with C-reactive protein (ASDAS-CRP). Consists of four questions on pain in neck, back, and hip, morning stiffness, well-being, and pain/stiffness in other joints in addition to blood test of CRP. Score 0-4 (\<1.3 inactive disease, \>3,5 very high disease activity). Equation ASDAS-CRP = 0.12 x Back Pain + 0.06 x Duration of Morning Stiffness + 0.11 x Patient Global + 0.07 x Peripheral Pain/Swelling + 0.58 x Ln(CRP+1)

  after 3 months

• Self-reported disease activity ASDAS-CRP

  Ankylosing Spondylitis Disease Activity Score with C-reactive protein (ASDAS-CRP). Consists of four questions on pain in neck, back, and hip, morning stiffness, well-being, and pain/stiffness in other joints in addition to blood test of CRP. Score 0-4 (\<1.3 inactive disease, \>3,5 very high disease activity). Equation ASDAS-CRP = 0.12 x Back Pain + 0.06 x Duration of Morning Stiffness + 0.11 x Patient Global + 0.07 x Peripheral Pain/Swelling + 0.58 x Ln(CRP+1)

  after 12 months

• Biomarker C-reaktivt protein (CRP)

  Venous blood to study CRP level by ELISA in µg/ml

  after 3 months

• Biomarker C-reaktivt protein (CRP)

  Venous blood to study CRP level by ELISA in µg/ml

  after 12 months

• Biomarker Pentraxin-related protein (PTX3)

  Venous blood to study PTX3 by ELISA in µg/ml

  after 3 months

• Biomarker Pentraxin-related protein (PTX3)

  Venous blood to study PTX3 by ELISA in µg/ml

  after 12 months

• Biomarker serum amyloid A1

  Venous blood to study serum amyloid A1 by ELISA in µg/ml

  after 3 months

• Biomarker serum amyloid A1

  Venous blood to study serum amyloid A1 by ELISA in µg/ml

  after 12 months

Secondary Outcomes (86)

• Aerobic capacity VO2max

  after 3 months

• Aerobic capacity VO2max

  after 12 months

• Blood pressure

  after 3 months

• Blood pressure

  after 12 months

• Grip strength

  after 3 months

Study Arms (2)

HIIT-intervention group

EXPERIMENTAL

12 weeks of structured high intensity interval training followed by 9 month of self-selected training

Behavioral: High intensity interval training (HIIT)

Control group

ACTIVE COMPARATOR

Continuing with their usual exercise habits during 12 months

Other: Control group

Interventions

High intensity interval training (HIIT) BEHAVIORAL

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

HIIT-intervention group

Control group OTHER

Continuing with exercise as usual during 12 months

Control group

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Axial SpA (ICD10 diagnosis of M45, M46.0, M46.1, M46.8 and M46.9).
• Fulfilling recommendations for physical activity

You may not qualify if:

• Changed TNF and anti-inflammatory medication the previous three months
• Cardiovascular disease
• Comorbidities making high-intensity training inappropriate
• Performing high-intensity interval training on a regular basis

Sponsors & Collaborators

• Halmstad University: lead

Study Sites (1)

Halmstad University

Halmstad, Halland County, 30118, Sweden

RECRUITING

MeSH Terms

Conditions

Axial Spondyloarthritis

Interventions

High-Intensity Interval Training; Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Haglund, Assoc. prof.

  Dept. of Environmental and Biosciences, Halmstad University, Sweden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emma Haglund, Assoc. prof.

CONTACT

+46703838848; emma.haglund@hh.se

Åsa Andersson, Prof.

CONTACT

+46 733039625; asa.andersson@hh.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor in biomedicine

Model Details: Participants will be randomly assigned into intervention- and control groups. Simple randomization will be used for equal group allocation at three different rheumatology clinics in southern Sweden. The patients will choose a sealed note in which one of the words "intervention" or "control" is written, when the baseline assessment is completed at the first measurement occasion.

Study Record Dates

• First Submitted: February 5, 2023
• First Posted: March 23, 2023
• Study Start: March 21, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 23, 2023

Record last verified: 2023-03

Locations

SE (1)