We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02356874
Recruitment Status : Completed
First Posted : February 5, 2015
Last Update Posted : August 2, 2018
Sponsor:
Collaborators:
University of Oslo
Norwegian School of Sport Sciences
Information provided by (Responsible Party):
Silje H Sveaas, PT, PhD, Diakonhjemmet Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).

Condition or disease Intervention/treatment Phase
Axial Spondyloarthritis Behavioral: Exercise Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : August 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Disease activity [ Time Frame: 3 months ]
    The Ankylosing Spondylitis Disease Activity Score (ASDAS) and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)


Secondary Outcome Measures :
  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)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02356874


Locations
Layout table for location information
Norway
Martina Hansens Hospital AS
Bærum, Norway, 1306
Diakonhjemmet Hospital AS
Oslo, Norway, 0319
University Hospital of North Norway
Tromsø, Norway, 9038
Sweden
University of Gotenburg
Gotenburg, Sweden
Sponsors and Collaborators
Diakonhjemmet Hospital
University of Oslo
Norwegian School of Sport Sciences
Investigators
Layout table for investigator information
Principal Investigator: Hanne H Dagfinrud, PhD Nationonal Advisory Unit on Rehabilitation in Rheumatology, Departement of Rheumatology, Diakonhjemmet Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Silje H Sveaas, PT, PhD, PhD, Diakonhjemmet Hospital
ClinicalTrials.gov Identifier: NCT02356874    
Other Study ID Numbers: 97026: The ESpA study
First Posted: February 5, 2015    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: February 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Spondylitis
Spondylarthritis
Bone Diseases, Infectious
Infections
Bone Diseases
 Musculoskeletal Diseases
Spinal Diseases
Arthritis
Joint Diseases