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

August 1, 2018 updated by: Silje H Sveaas, PT, PhD, Diakonhjemmet Hospital

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bærum, Norway, 1306
        • Martina Hansens Hospital AS
      • Oslo, Norway, 0319
        • Diakonhjemmet Hospital AS
      • Tromsø, Norway, 9038
        • University Hospital of North Norway
  • Sweden
      • Gotenburg, Sweden
        • University of Gotenburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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
  2. Not able to participate in weekly exercises sessions
  3. Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise group
Exercise
Behavioral: Exercise
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.
No Intervention: Control group
Participants in the control group will be asked to continue their usual physical activity habits

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease activity
Time Frame: 3 months
The Ankylosing Spondylitis Disease Activity Score (ASDAS) and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure
Time Frame: 3 months
3 months
Blood samples
Time Frame: 3 months (all analyses) 12 months (only CRP and ESR)
General and specific markers of inflammation and cardiovascular risk
3 months (all analyses) 12 months (only CRP and ESR)
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 months
Physical function
Time Frame: 3 months and 12 months
The Bath Ankylosing Spondylitis functional Index (BASFI).
3 months and 12 months
Cardiorespiratory fitness
Time Frame: 3 months
Maximal walking test on a treadmill for estimation of maximal oxygen uptake.
3 months
Body composition
Time Frame: 3 months
Body weight, body height, waist and hip circumference. DXA scan of a sample of patients.
3 months
Arterial stiffness
Time Frame: 3 months
Pulse wave velocity and argumentation Index
3 months
Endothelial function
Time Frame: 3 months
Digital plethysmography using the non-invasive ADMAR apparatus (sample of participants)
3 months
General health
Time Frame: 3 months and 12 months
Assessed with the general health questionnaire (GHQ-12)
3 months and 12 months
Health related quality of life
Time Frame: 3 months and 12 months
Euro Quol 5D (EQ5D)
3 months and 12 months
Physical activity level
Time Frame: 3 months and 12 months
Questionaire of frequency, intensity and duration of physical activity
3 months and 12 months
Self-efficacy for physical activity
Time Frame: 3 months and 12 months
Questionnaire
3 months and 12 months
Fatigue
Time Frame: 3 months and 12 months
The fatigue severity scale and the SF-36 vitality scale (version 1)
3 months and 12 months
Sleep
Time Frame: 3 months and 12 months
Pittsburgh Sleep Quality Index (PSQI)
3 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diakonhjemmet Hospital

Collaborators

University of Oslo
Norwegian School of Sport Sciences

Investigators

  • Principal Investigator: Hanne H Dagfinrud, PhD, Nationonal Advisory Unit on Rehabilitation in Rheumatology, Departement of Rheumatology, Diakonhjemmet Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

January 21, 2015

First Submitted That Met QC Criteria

February 2, 2015

First Posted (Estimate)

February 5, 2015

Study Record Updates

Last Update Posted (Actual)

August 2, 2018

Last Update Submitted That Met QC Criteria

August 1, 2018

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 97026: The ESpA study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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