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

Axial Spondyloarthritis Clinical Trial

— ESpA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02356874
• Other study ID #: 97026: The ESpA study
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: September 2017

Study information

• Verified date: February 2017
• Source: Diakonhjemmet Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Axial Spondyloarthritis
• Spondylarthritis

Intervention

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.

Locations

Country	Name	City	State
Norway	Martina Hansens Hospital AS	Bærum
Norway	Diakonhjemmet Hospital AS	Oslo
Norway	University Hospital of North Norway	Tromsø
Sweden	University of Gotenburg	Gotenburg

Sponsors (3)

Lead Sponsor	Collaborator
Diakonhjemmet Hospital	Norwegian School of Sport Sciences, University of Oslo

Countries where clinical trial is conducted

Norway,  Sweden, 

Outcome

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