NCT02356874

Brief Summary

The overall aim of this multicenter randomised controlled trial (RCT) is to investigate if exercise can modify the disease course and prevent comorbidity in patient with spondyloarthritis (SpA).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

Typical duration for not_applicable

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 5, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

August 2, 2018

Status Verified

February 1, 2017

Enrollment Period

1.3 years

First QC Date

January 21, 2015

Last Update Submit

August 1, 2018

Conditions

Axial Spondyloarthritis

Outcome Measures

Primary Outcomes (1)

  • Disease activity

    The Ankylosing Spondylitis Disease Activity Score (ASDAS) and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

    3 months

Secondary Outcomes (14)

  • Blood samples

    3 months (all analyses) 12 months (only CRP and ESR)

  • Spinal mobility

    3 months

  • Physical function

    3 months and 12 months

  • Cardiorespiratory fitness

    3 months

  • Body composition

    3 months

  • +9 more secondary outcomes

Study Arms (2)

Exercise group

EXPERIMENTAL

Exercise

Behavioral: Exercise

Control group

NO INTERVENTION

Participants in the control group will be asked to continue their usual physical activity habits

Interventions

ExerciseBEHAVIORAL

An exercise program for 40-60 minutes three times a week in 3 months. Twice a week the exercise sessions will be supervised by a physiotherapist and these sessions will consist of endurance and strength training. The endurance training will be high intensity interval training on a treadmill. And strength training with external load for the major muscle groups (individually adapted: six exercises, eight to ten repetitions maximum, two to three sets). Once a week the participants will exercise individually for a minimum of 40 minutes of endurance exercise.

Exercise group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of axial SpA (the Assessment of SpondyloArthritis International Society classification criteria) confirmed by a rheumatologist
  • Age, 18-70 -years
  • Steady medication for ≥3 months
  • Moderate disease activity defined as a BASDAI score of ≥3.5 or a patient global score ≥3.5
  • Not participated in a structured endurance and strength exercise program during the last 6 months (\>1 hour/week)

You may not qualify if:

  • Severe co-morbidity which involves reduced exercise capacity and/or contraindications for physical activity as per American College of Sports Medicine guidelines for exercise testing
  • Not able to participate in weekly exercises sessions
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Martina Hansens Hospital AS

Bærum, 1306, Norway

Location

Diakonhjemmet Hospital AS

Oslo, 0319, Norway

Location

University Hospital of North Norway

Tromsø, 9038, Norway

Location

University of Gotenburg

Gothenburg, Sweden

Location

Related Publications (6)

  • Fongen C, Dagfinrud H, Bilberg A, Sveaas SH. Reduced sleep quality is highly prevalent and associated with physical function and cardiorespiratory fitness in patients with axial spondyloarthritis: a cross-sectional study. Scand J Rheumatol. 2024 Mar;53(2):130-139. doi: 10.1080/03009742.2023.2281069. Epub 2023 Dec 14.

    PMID: 38095452DERIVED

  • Bilberg A, Dagfinrud H, Sveaas SH. Supervised Intensive Exercise for Strengthening Exercise Health Beliefs in Patients With Axial Spondyloarthritis: A Multicenter Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2022 Jul;74(7):1196-1204. doi: 10.1002/acr.24556. Epub 2022 Apr 17.

    PMID: 33423392DERIVED

  • Sveaas SH, Dagfinrud H, Berg IJ, Provan SA, Johansen MW, Pedersen E, Bilberg A. High-Intensity Exercise Improves Fatigue, Sleep, and Mood in Patients With Axial Spondyloarthritis: Secondary Analysis of a Randomized Controlled Trial. Phys Ther. 2020 Aug 12;100(8):1323-1332. doi: 10.1093/ptj/pzaa086.

    PMID: 32367124DERIVED

  • Fongen C, Dagfinrud H, Bilberg A, Pedersen E, Johansen MW, van Weely S, Hagen KB, Sveaas SH. Responsiveness and Interpretability of 2 Measures of Physical Function in Patients With Spondyloarthritis. Phys Ther. 2020 Apr 17;100(4):728-738. doi: 10.1093/ptj/pzaa004.

    PMID: 31944251DERIVED

  • Sveaas SH, Dagfinrud H, Johansen MW, Pedersen E, Wold OM, Bilberg A. Longterm Effect on Leisure Time Physical Activity Level in Individuals with Axial Spondyloarthritis: Secondary Analysis of a Randomized Controlled Trial. J Rheumatol. 2020 Aug 1;47(8):1189-1197. doi: 10.3899/jrheum.190317. Epub 2019 Nov 15.

    PMID: 31732552DERIVED

  • Sveaas SH, Bilberg A, Berg IJ, Provan SA, Rollefstad S, Semb AG, Hagen KB, Johansen MW, Pedersen E, Dagfinrud H. High intensity exercise for 3 months reduces disease activity in axial spondyloarthritis (axSpA): a multicentre randomised trial of 100 patients. Br J Sports Med. 2020 Mar;54(5):292-297. doi: 10.1136/bjsports-2018-099943. Epub 2019 Feb 11.

    PMID: 30745314DERIVED

MeSH Terms

Conditions

Axial Spondyloarthritis

Interventions

Exercise

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Hanne H Dagfinrud, PhD

    Nationonal Advisory Unit on Rehabilitation in Rheumatology, Departement of Rheumatology, Diakonhjemmet Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

January 21, 2015

First Posted

February 5, 2015

Study Start

August 1, 2015

Primary Completion

December 1, 2016

Study Completion

September 1, 2017

Last Updated

August 2, 2018

Record last verified: 2017-02

Locations

SE(1)NO(3)