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

Primary Purpose

Axial Spondyloarthritis

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Exercise
Sponsored by
Diakonhjemmet Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Axial Spondyloarthritis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Martina Hansens Hospital AS
  • Diakonhjemmet Hospital AS
  • University Hospital of North Norway
  • University of Gotenburg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise group

Control group

Arm Description

Exercise

Participants in the control group will be asked to continue their usual physical activity habits

Outcomes

Primary Outcome Measures

Disease activity
The Ankylosing Spondylitis Disease Activity Score (ASDAS) and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

Secondary Outcome Measures

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

Full Information

First Posted
January 21, 2015
Last Updated
August 1, 2018
Sponsor
Diakonhjemmet Hospital
Collaborators
University of Oslo, Norwegian School of Sport Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02356874
Brief Title
The Effect of Exercise on Disease Activity and Cardiovascular Risk for Patients With Axial SpondyloArthritis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diakonhjemmet Hospital
Collaborators
University of Oslo, Norwegian School of Sport Sciences

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Axial Spondyloarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise group
Arm Type
Experimental
Arm Description
Exercise
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants in the control group will be asked to continue their usual physical activity habits
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Disease activity
Description
The Ankylosing Spondylitis Disease Activity Score (ASDAS) and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Blood samples
Description
General and specific markers of inflammation and cardiovascular risk
Time Frame
3 months (all analyses) 12 months (only CRP and ESR)
Title
Spinal mobility
Description
The Bath Ankylosing Spondylitis Metrology Index (BASMI). BASMI includes five measurements of flexibility in the spine, neck and hips.
Time Frame
3 months
Title
Physical function
Description
The Bath Ankylosing Spondylitis functional Index (BASFI).
Time Frame
3 months and 12 months
Title
Cardiorespiratory fitness
Description
Maximal walking test on a treadmill for estimation of maximal oxygen uptake.
Time Frame
3 months
Title
Body composition
Description
Body weight, body height, waist and hip circumference. DXA scan of a sample of patients.
Time Frame
3 months
Title
Arterial stiffness
Description
Pulse wave velocity and argumentation Index
Time Frame
3 months
Title
Endothelial function
Description
Digital plethysmography using the non-invasive ADMAR apparatus (sample of participants)
Time Frame
3 months
Title
Blood pressure
Time Frame
3 months
Title
General health
Description
Assessed with the general health questionnaire (GHQ-12)
Time Frame
3 months and 12 months
Title
Health related quality of life
Description
Euro Quol 5D (EQ5D)
Time Frame
3 months and 12 months
Title
Physical activity level
Description
Questionaire of frequency, intensity and duration of physical activity
Time Frame
3 months and 12 months
Title
Self-efficacy for physical activity
Description
Questionnaire
Time Frame
3 months and 12 months
Title
Fatigue
Description
The fatigue severity scale and the SF-36 vitality scale (version 1)
Time Frame
3 months and 12 months
Title
Sleep
Description
Pittsburgh Sleep Quality Index (PSQI)
Time Frame
3 months and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of axial SpA (the Assessment of SpondyloArthritis International Society classification criteria) confirmed by a rheumatologist Age, 18-70 -years Steady medication for ≥3 months Moderate disease activity defined as a BASDAI score of ≥3.5 or a patient global score ≥3.5 Not participated in a structured endurance and strength exercise program during the last 6 months (>1 hour/week) Exclusion Criteria: 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 Not able to participate in weekly exercises sessions Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanne H Dagfinrud, PhD
Organizational Affiliation
Nationonal Advisory Unit on Rehabilitation in Rheumatology, Departement of Rheumatology, Diakonhjemmet Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Martina Hansens Hospital AS
City
Bærum
ZIP/Postal Code
1306
Country
Norway
Facility Name
Diakonhjemmet Hospital AS
City
Oslo
ZIP/Postal Code
0319
Country
Norway
Facility Name
University Hospital of North Norway
City
Tromsø
ZIP/Postal Code
9038
Country
Norway
Facility Name
University of Gotenburg
City
Gotenburg
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
33423392
Citation
Bilberg A, Dagfinrud H, Sveaas SH. Supervised Intensive Exercise for Strengthening Exercise Health Beliefs in Patients With Axial Spondyloarthritis: A Multicenter Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2022 Jul;74(7):1196-1204. doi: 10.1002/acr.24556. Epub 2022 Apr 17. Erratum In: Arthritis Care Res (Hoboken). 2022 Dec;74(12):2118.
Results Reference
derived
PubMed Identifier
32367124
Citation
Sveaas SH, Dagfinrud H, Berg IJ, Provan SA, Johansen MW, Pedersen E, Bilberg A. High-Intensity Exercise Improves Fatigue, Sleep, and Mood in Patients With Axial Spondyloarthritis: Secondary Analysis of a Randomized Controlled Trial. Phys Ther. 2020 Aug 12;100(8):1323-1332. doi: 10.1093/ptj/pzaa086.
Results Reference
derived
PubMed Identifier
31944251
Citation
Fongen C, Dagfinrud H, Bilberg A, Pedersen E, Johansen MW, van Weely S, Hagen KB, Sveaas SH. Responsiveness and Interpretability of 2 Measures of Physical Function in Patients With Spondyloarthritis. Phys Ther. 2020 Apr 17;100(4):728-738. doi: 10.1093/ptj/pzaa004.
Results Reference
derived
PubMed Identifier
31732552
Citation
Sveaas SH, Dagfinrud H, Johansen MW, Pedersen E, Wold OM, Bilberg A. Longterm Effect on Leisure Time Physical Activity Level in Individuals with Axial Spondyloarthritis: Secondary Analysis of a Randomized Controlled Trial. J Rheumatol. 2020 Aug 1;47(8):1189-1197. doi: 10.3899/jrheum.190317. Epub 2019 Nov 15.
Results Reference
derived
PubMed Identifier
30745314
Citation
Sveaas SH, Bilberg A, Berg IJ, Provan SA, Rollefstad S, Semb AG, Hagen KB, Johansen MW, Pedersen E, Dagfinrud H. High intensity exercise for 3 months reduces disease activity in axial spondyloarthritis (axSpA): a multicentre randomised trial of 100 patients. Br J Sports Med. 2020 Mar;54(5):292-297. doi: 10.1136/bjsports-2018-099943. Epub 2019 Feb 11.
Results Reference
derived

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

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