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NCT Number: NCT02356874

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

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).

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Key information

Conditions

Axial Spondyloarthritis Ankylosis Arthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Martina Hansens Hospital AS, Bærum, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Exercise

Behavioral

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.

Primary outcomes

  1. Disease activity

    Time frame: 3 months

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

Secondary outcomes

  1. Blood samples

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

    General and specific markers of inflammation and cardiovascular risk

  2. Spinal mobility

    Time frame: 3 months

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

  3. Physical function

    Time frame: 3 months and 12 months

    The Bath Ankylosing Spondylitis functional Index (BASFI).

  4. Cardiorespiratory fitness

    Time frame: 3 months

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

  5. Body composition

    Time frame: 3 months

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

  6. Arterial stiffness

    Time frame: 3 months

    Pulse wave velocity and argumentation Index

  7. Endothelial function

    Time frame: 3 months

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

  8. Blood pressure

    Time frame: 3 months

  9. General health

    Time frame: 3 months and 12 months

    Assessed with the general health questionnaire (GHQ-12)

  10. Health related quality of life

    Time frame: 3 months and 12 months

    Euro Quol 5D (EQ5D)

  11. Physical activity level

    Time frame: 3 months and 12 months

    Questionaire of frequency, intensity and duration of physical activity

  12. Self-efficacy for physical activity

    Time frame: 3 months and 12 months

    Questionnaire

  13. Fatigue

    Time frame: 3 months and 12 months

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

  14. Sleep

    Time frame: 3 months and 12 months

    Pittsburgh Sleep Quality Index (PSQI)

Sponsors and collaborators

Lead sponsor

Diakonhjemmet Hospital

Other

Collaborators

  • Norwegian School of Sport Sciences
  • University of Oslo

Registry information

Official study 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

Acronym: ESpA

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Feb 5, 2015
Registry last updated
Aug 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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