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Axial SpondyloarthritisESpANCT02356874

The Effect of Exercise on Disease Activity and Cardiovascular Risk for Patients With Axial SpondyloArthritis

A study testing Exercise in people with Axial Spondyloarthritis, run by Diakonhjemmet Hospital at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Axial Spondyloarthritis
What is being tested?
Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
4 sitesin 2 countries
Study dates
Aug 2015to Sep 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

Norway3 sites

  • Martina Hansens Hospital AS

    Bærum, 1306

  • Diakonhjemmet Hospital AS

    Oslo, 0319

  • University Hospital of North Norway

    Tromsø, 9038

Other trials in Norway

Sweden1 site

  • University of Gotenburg

    Gothenburg

Other trials in Sweden

About this study

Official title: Exercise for SpondyloArthritis (SpA) - the ESpA Study The Effect of a Supervised Exercise Intervention on Disease Activity and Cardiovascular Risk in Patients With SpA - A Multicenter Randomized Controlled Trial

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).

Read the detailed description

International guidelines recommend exercise as a cornerstone in the management of SpA. Due to the typical features of SpA with reduced spinal mobility, the main focus for exercise has been flexibility exercise. Exercise trials for this patient group have mainly aimed at improving spinal mobility and there is limited evidence of the potential effects of exercise on disease pathogenesis and CVD risk factors.

Being tested
Exercise
Medical subject headings
Axial Spondyloarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseBehavioural

    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.

Study groups in NCT02356874
Study groupRoleWhat they receive
Exercise groupExperimentalExercise
Receives: Behavioral: Exercise
Control groupNo interventionParticipants in the control group will be asked to continue their usual physical activity habits

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease activity

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

    Measured: 3 months

Secondary outcomes (14)

  1. Blood samples

    General and specific markers of inflammation and cardiovascular risk

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

  2. Spinal mobility

    The Bath Ankylosing Spondylitis Metrology Index (BASMI). BASMI includes five measurements of flexibility in the spine, neck and hips.

    Measured: 3 months

  3. Physical function

    The Bath Ankylosing Spondylitis functional Index (BASFI).

    Measured: 3 months and 12 months

  4. Cardiorespiratory fitness

    Maximal walking test on a treadmill for estimation of maximal oxygen uptake.

    Measured: 3 months

  5. Body composition

    Body weight, body height, waist and hip circumference. DXA scan of a sample of patients.

    Measured: 3 months

  6. Arterial stiffness

    Pulse wave velocity and argumentation Index

    Measured: 3 months

  7. Endothelial function

    Digital plethysmography using the non-invasive ADMAR apparatus (sample of participants)

    Measured: 3 months

  8. Blood pressure

    Measured: 3 months

  9. General health

    Assessed with the general health questionnaire (GHQ-12)

    Measured: 3 months and 12 months

  10. Health related quality of life

    Euro Quol 5D (EQ5D)

    Measured: 3 months and 12 months

  11. Physical activity level

    Questionaire of frequency, intensity and duration of physical activity

    Measured: 3 months and 12 months

  12. Self-efficacy for physical activity

    Questionnaire

    Measured: 3 months and 12 months

  13. Fatigue

    The fatigue severity scale and the SF-36 vitality scale (version 1)

    Measured: 3 months and 12 months

  14. Sleep

    Pittsburgh Sleep Quality Index (PSQI)

    Measured: 3 months and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2015 (estimated)
  2. Study startAug 2015
  3. Primary completionDec 2016
  4. Study completionSep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02356874
Sponsor's protocol ID
97026: The ESpA study
Acronym
ESpA
Status last verified
Feb 2017
First submitted
21 Jan 2015
Last updated
2 Aug 2018
Results posted
No

Publications

  • 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.

    PubMed 38095452

  • 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.

    PubMed 33423392

  • 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.

    PubMed 32367124

  • 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.

    PubMed 31944251

  • 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.

    PubMed 31732552

  • 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.

    PubMed 30745314

Questions about this trial

What is this clinical trial studying?

A study testing Exercise in people with Axial Spondyloarthritis, run by Diakonhjemmet Hospital at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Norway, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease activity (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02356874, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2018.

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