Effects of Aerobic Training in Patients With Ankylosing Spondylitis
Primary Purpose
Ankylosing Spondylitis
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
aerobic training
Stretching exercises
Sponsored by
About this trial
This is an interventional treatment trial for Ankylosing Spondylitis focused on measuring ankylosing spondylitis, aerobic exercise
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Ankylosing Spondylitis according to New York modified criteria.
- Stable drug treatment for at least 3 months
- Sedentary for at least 3 months before randomization
- Steinbrocker class I/II
Exclusion Criteria:
Uncontrolled Systemic Arterial Hypertension and Diabetes mellitus.
- Ischemic heart disease
- Clinically significant diseases
- Orthopedic surgery, such as hip arthroplasty, in the last year.
- Inability to walk.
Sites / Locations
- Universidade Federal de Sao Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Aerobic training
Stretching exercises
Arm Description
The patients in this arm perform a 50-minute-walking at anaerobic threshold plus stretching exercises 3 times a week for 12 weeks.
The control group perform global stretching exercises for approximately 20 minutes 3 times a week for 12 weeks.
Outcomes
Primary Outcome Measures
Change in BASFI
Bath Ankylosing Spondylitis Functional Index (BASFI) is a quaestionnaire with 10 questions about functional capacity validated to AS patients. Each question is answered with a visual analogue scale 0-10 cm. Zero means the best, and 10 the worst function.
Secondary Outcome Measures
Change in BASDAI
Bath Ankylosing Spondylitis Disease Activity Score (BASDAI) is a instrument with 6 questions about disease activity validated to AS patients. The questions comprise the following areas: back pain, peripheral pain, morning stifness, fatigue and enthesitis.
Change in BASMI
Bath Ankylosing Spondylitis Mobility Index (BASMI) is an instrument that comprises 5 measures of mobility validated to AS patients. The measurements are: cervical rotation, lumbar flexion (Schober's test modified, intermalleolar distance, lumbar side flexion and tragus to wall. The total score is shown in a 0-10 cm visual analogue scale. The low scores represent better mobility.
Change in HAQ-S
Health Assessment Questionnaire for Spondyloarthritis (HAQ-S)is a questionnaire with 10 domains about functional capacity validated to AS patients. The scores ranges from 0 to 3.
Incremental cardiopulmonary exercise testing protocol by treadmill
Incremental cardiopulmonary exercise testing protocol by treadmill is used to measure aerobic capacity of the patients.
Levels of C reactive protein and erythrocyte rate sedimentation
CRP and ESR are laboratory methods to evaluate inflammatory response using blood sample.
Levels of cytokines- TNF, IL10, IL6 and IL1.
Cytokines are substances that make part of inflammatory response. The most important cytokines- TNF alpha, IL10, IL6 and IL1 will be measured in serum samples.
Change in the Six minute walking test
The 6-minute walking test is a instrument to evaluate functional capacity. It is performed measuring the distance that the participant is able to walk during 6 minutes.
Full Information
NCT ID
NCT01586650
First Posted
April 21, 2012
Last Updated
February 14, 2017
Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01586650
Brief Title
Effects of Aerobic Training in Patients With Ankylosing Spondylitis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a randomized controlled trial with blinded assessor on the effects of aerobic exercise (walking)in patients with Ankylosing Spondylitis.
Detailed Description
Ankylosing Spondylitis (AS) is a systemic inflammatory disease that affects mainly the spine and compromises globally the physical capacity of the patients. Despite new advances in pharmacological therapy, physiotherapy and exercise remain essential in the treatment of AS. However, the literature lacks studies showing which types of exercises are more effective in patients with AS.
This is a randomized controlled trial with the objective is to evaluate the effects of aerobic training on functional capacity, mobility, disease activity, cardiopulmonary capacity and cytokine levels (TNF, IL10, IL6 and IL1) in patients with AS.
The duration of the trial is 24 weeks with the first 12 weeks reserved to exercise programs. The participants will be divided in two groups. The intervention group (IG) will perform walking for 50 minutes plus global stretching 3 times a week for 12 weeks. The control group (CG) will do only stretching exercises 3 times a week for 12 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis
Keywords
ankylosing spondylitis, aerobic exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aerobic training
Arm Type
Experimental
Arm Description
The patients in this arm perform a 50-minute-walking at anaerobic threshold plus stretching exercises 3 times a week for 12 weeks.
Arm Title
Stretching exercises
Arm Type
Placebo Comparator
Arm Description
The control group perform global stretching exercises for approximately 20 minutes 3 times a week for 12 weeks.
Intervention Type
Other
Intervention Name(s)
aerobic training
Intervention Description
The intervention comprises fifty minutes of walking at anaerobic threshold plus stretching exercises 3 times a week for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Stretching exercises
Intervention Description
Global stretching exercises will be performed for about 20 minutes 3 times a week for 12 weeks with supervision of specialized physiotherapists.
Primary Outcome Measure Information:
Title
Change in BASFI
Description
Bath Ankylosing Spondylitis Functional Index (BASFI) is a quaestionnaire with 10 questions about functional capacity validated to AS patients. Each question is answered with a visual analogue scale 0-10 cm. Zero means the best, and 10 the worst function.
Time Frame
Baseline, after 6, 12 and 24 weeks.
Secondary Outcome Measure Information:
Title
Change in BASDAI
Description
Bath Ankylosing Spondylitis Disease Activity Score (BASDAI) is a instrument with 6 questions about disease activity validated to AS patients. The questions comprise the following areas: back pain, peripheral pain, morning stifness, fatigue and enthesitis.
Time Frame
Baseline, after 6, 12 and 24 weeks.
Title
Change in BASMI
Description
Bath Ankylosing Spondylitis Mobility Index (BASMI) is an instrument that comprises 5 measures of mobility validated to AS patients. The measurements are: cervical rotation, lumbar flexion (Schober's test modified, intermalleolar distance, lumbar side flexion and tragus to wall. The total score is shown in a 0-10 cm visual analogue scale. The low scores represent better mobility.
Time Frame
Baseline, after 6, 12 and 24 weeks.
Title
Change in HAQ-S
Description
Health Assessment Questionnaire for Spondyloarthritis (HAQ-S)is a questionnaire with 10 domains about functional capacity validated to AS patients. The scores ranges from 0 to 3.
Time Frame
Baseline, after 6, 12 and 24 weeks.
Title
Incremental cardiopulmonary exercise testing protocol by treadmill
Description
Incremental cardiopulmonary exercise testing protocol by treadmill is used to measure aerobic capacity of the patients.
Time Frame
Baseline and after 12 weeks.
Title
Levels of C reactive protein and erythrocyte rate sedimentation
Description
CRP and ESR are laboratory methods to evaluate inflammatory response using blood sample.
Time Frame
Baseline, after 6. 12 and 24 weeks
Title
Levels of cytokines- TNF, IL10, IL6 and IL1.
Description
Cytokines are substances that make part of inflammatory response. The most important cytokines- TNF alpha, IL10, IL6 and IL1 will be measured in serum samples.
Time Frame
Baseline and after 12 weeks.
Title
Change in the Six minute walking test
Description
The 6-minute walking test is a instrument to evaluate functional capacity. It is performed measuring the distance that the participant is able to walk during 6 minutes.
Time Frame
Baseline, after 6, 12 and 24 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Ankylosing Spondylitis according to New York modified criteria.
Stable drug treatment for at least 3 months
Sedentary for at least 3 months before randomization
Steinbrocker class I/II
Exclusion Criteria:
Uncontrolled Systemic Arterial Hypertension and Diabetes mellitus.
Ischemic heart disease
Clinically significant diseases
Orthopedic surgery, such as hip arthroplasty, in the last year.
Inability to walk.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamil Natour, Prof, MD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Director
Facility Information:
Facility Name
Universidade Federal de Sao Paulo
City
Sao Paulo
ZIP/Postal Code
04039-002
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
21540199
Citation
Braun J, van den Berg R, Baraliakos X, Boehm H, Burgos-Vargas R, Collantes-Estevez E, Dagfinrud H, Dijkmans B, Dougados M, Emery P, Geher P, Hammoudeh M, Inman RD, Jongkees M, Khan MA, Kiltz U, Kvien T, Leirisalo-Repo M, Maksymowych WP, Olivieri I, Pavelka K, Sieper J, Stanislawska-Biernat E, Wendling D, Ozgocmen S, van Drogen C, van Royen B, van der Heijde D. 2010 update of the ASAS/EULAR recommendations for the management of ankylosing spondylitis. Ann Rheum Dis. 2011 Jun;70(6):896-904. doi: 10.1136/ard.2011.151027.
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Effects of Aerobic Training in Patients With Ankylosing Spondylitis
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