Effects of Aerobic Training in Patients With Ankylosing Spondylitis

This is a randomized controlled trial with blinded assessor on the effects of aerobic exercise (walking)in patients with Ankylosing Spondylitis.

Study Overview

• Status: Completed
• Conditions: Ankylosing Spondylitis
• Intervention / Treatment: Other: aerobic training; Other: Stretching exercises

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 04039-002
    • Universidade Federal de Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aerobic training; The patients in this arm perform a 50-minute-walking at anaerobic threshold plus stretching exercises 3 times a week for 12 weeks.	Other: aerobic training; The intervention comprises fifty minutes of walking at anaerobic threshold plus stretching exercises 3 times a week for 12 weeks.; Other: Stretching exercises; Global stretching exercises will be performed for about 20 minutes 3 times a week for 12 weeks with supervision of specialized physiotherapists.
Placebo Comparator: Stretching exercises; The control group perform global stretching exercises for approximately 20 minutes 3 times a week for 12 weeks.	Other: Stretching exercises; Global stretching exercises will be performed for about 20 minutes 3 times a week for 12 weeks with supervision of specialized physiotherapists.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, after 6, 12 and 24 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, after 6, 12 and 24 weeks.
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.	Baseline, after 6, 12 and 24 weeks.
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.	Baseline, after 6, 12 and 24 weeks.
Incremental cardiopulmonary exercise testing protocol by treadmill	Incremental cardiopulmonary exercise testing protocol by treadmill is used to measure aerobic capacity of the patients.	Baseline and after 12 weeks.
Levels of C reactive protein and erythrocyte rate sedimentation	CRP and ESR are laboratory methods to evaluate inflammatory response using blood sample.	Baseline, after 6. 12 and 24 weeks
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.	Baseline and after 12 weeks.
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.	Baseline, after 6, 12 and 24 weeks.

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Investigators: Study Director: Jamil Natour, Prof, MD, Federal University of São Paulo

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: April 21, 2012
• First Submitted That Met QC Criteria: April 25, 2012
• First Posted (Estimate): April 27, 2012

Study Record Updates

• Last Update Posted (Actual): February 15, 2017
• Last Update Submitted That Met QC Criteria: February 14, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: aerobic exercise; ankylosing spondylitis
• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Spondylarthropathies; Bone Diseases, Infectious; Ankylosis; Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
• Other Study ID Numbers: 1325/08