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
|Condition or disease||Intervention/treatment||Phase|
|Axial Spondyloarthritis||Behavioral: Exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|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|
Experimental: Exercise group
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
- Disease activity [ Time Frame: 3 months ]The Ankylosing Spondylitis Disease Activity Score (ASDAS) and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
- 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)
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
|Martina Hansens Hospital AS|
|Bærum, Norway, 1306|
|Diakonhjemmet Hospital AS|
|Oslo, Norway, 0319|
|University Hospital of North Norway|
|Tromsø, Norway, 9038|
|University of Gotenburg|
|Principal Investigator:||Hanne H Dagfinrud, PhD||Nationonal Advisory Unit on Rehabilitation in Rheumatology, Departement of Rheumatology, Diakonhjemmet Hospital|