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

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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

Tracking Information
First Submitted Date  ICMJE January 21, 2015
First Posted Date  ICMJE February 5, 2015
Last Update Posted Date August 2, 2018
Study Start Date  ICMJE August 2015
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 27, 2016)
Disease activity [ Time Frame: 3 months ]
The Ankylosing Spondylitis Disease Activity Score (ASDAS) and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Original Primary Outcome Measures  ICMJE
 (submitted: February 2, 2015)
Disease activity [ Time Frame: after 3 months and 6 months ]
The Ankylosing Spondylitis Disease Activity Score (ASDAS) and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2016)
  • Blood samples [ Time Frame: 3 months (all analyses) 12 months (only CRP and ESR) ]
    General and specific markers of inflammation and cardiovascular risk
  • 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.
  • Physical function [ Time Frame: 3 months and 12 months ]
    The Bath Ankylosing Spondylitis functional Index (BASFI).
  • Cardiorespiratory fitness [ Time Frame: 3 months ]
    Maximal walking test on a treadmill for estimation of maximal oxygen uptake.
  • Body composition [ Time Frame: 3 months ]
    Body weight, body height, waist and hip circumference. DXA scan of a sample of patients.
  • Arterial stiffness [ Time Frame: 3 months ]
    Pulse wave velocity and argumentation Index
  • Endothelial function [ Time Frame: 3 months ]
    Digital plethysmography using the non-invasive ADMAR apparatus (sample of participants)
  • Blood pressure [ Time Frame: 3 months ]
  • General health [ Time Frame: 3 months and 12 months ]
    Assessed with the general health questionnaire (GHQ-12)
  • Health related quality of life [ Time Frame: 3 months and 12 months ]
    Euro Quol 5D (EQ5D)
  • Physical activity level [ Time Frame: 3 months and 12 months ]
    Questionaire of frequency, intensity and duration of physical activity
  • Self-efficacy for physical activity [ Time Frame: 3 months and 12 months ]
    Questionnaire
  • Fatigue [ Time Frame: 3 months and 12 months ]
    The fatigue severity scale and the SF-36 vitality scale (version 1)
  • Sleep [ Time Frame: 3 months and 12 months ]
    Pittsburgh Sleep Quality Index (PSQI)
Original Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2015)
  • Blood samples [ Time Frame: 3 months and 6 months ]
    General and specific markers of inflammation and cardiovascular risk
  • MRI of columna and sacroiliac joints [ Time Frame: 3 months and 6 months ]
    (sample of patients)
  • Spinal mobility [ Time Frame: 3 months and 6 months ]
    The Bath Ankylosing Spondylitis Metrology Index (BASMI). BASMI includes five measurements of flexibility in the spine, neck and hips.
  • Physical function [ Time Frame: 3 months and 6 months ]
    The Bath Ankylosing Spondylitis functional Index (BASFI).
  • Cardiorespiratory fitness [ Time Frame: after 3 months and 6 months ]
    Maximal walking test on a treadmill for estimation of maximal oxygen uptake.
  • Body composition [ Time Frame: 3 months and 6 months ]
    Body weight, body height, waist and hip circumference. DXA scan of a sample of patients.
  • Arterial stiffness [ Time Frame: 3 months and 6 months ]
    Pulse wave velocity and argumentation Index
  • Endothelial function [ Time Frame: 3 months and 6 months ]
    Digital plethysmography using the non-invasive ADMAR apparatus (sample of participants)
  • Blood pressure [ Time Frame: 3 months and 6 months ]
  • Muscle biopsies [ Time Frame: 3 months ]
    Muscle fiber size and regulators of muscle fiber size (sample of patients)
  • General health [ Time Frame: 3 months and 6 months ]
    Assessed with the general health questionnaire (GHQ-12)
  • Health related quality of life [ Time Frame: 3 months and 6 months ]
    Euro Quol 5D (EQ5D)
  • Physical activity level [ Time Frame: 3 months and 6 months ]
    Questionaire of frequency, intensity and duration of physical activity
  • Self-efficacy for physical activity [ Time Frame: 3 months and 6 months ]
    Questionnaire
  • Fatigue [ Time Frame: 3 months and 6 months ]
    The fatigue severity scale and the SF-36 vitality scale (version 1)
  • Sleep [ Time Frame: 3 months and 6 months ]
    Pittsburgh Sleep Quality Index (PSQI)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Exercise on Disease Activity and Cardiovascular Risk for Patients With Axial SpondyloArthritis
Official Title  ICMJE 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
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).
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Axial Spondyloarthritis
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Exercise group
    Exercise
    Intervention: Behavioral: Exercise
  • No Intervention: Control group
    Participants in the control group will be asked to continue their usual physical activity habits
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 2, 2015)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2017
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02356874
Other Study ID Numbers  ICMJE 97026: The ESpA study
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Silje H Sveaas, PT, PhD, Diakonhjemmet Hospital
Study Sponsor  ICMJE Diakonhjemmet Hospital
Collaborators  ICMJE
  • University of Oslo
  • Norwegian School of Sport Sciences
Investigators  ICMJE
Principal Investigator: Hanne H Dagfinrud, PhD Nationonal Advisory Unit on Rehabilitation in Rheumatology, Departement of Rheumatology, Diakonhjemmet Hospital
PRS Account Diakonhjemmet Hospital
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP