Effects of Aerobic Training in Patients With Ankylosing Spondylitis

NCT ID: NCT01586650

Last Updated: 2017-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2013-02-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Ankylosing Spondylitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

aerobic training

Intervention Type OTHER

The intervention comprises fifty minutes of walking at anaerobic threshold plus stretching exercises 3 times a week for 12 weeks.

Stretching exercises

Intervention Type OTHER

Global stretching exercises will be performed for about 20 minutes 3 times a week for 12 weeks with supervision of specialized physiotherapists.

Stretching exercises

The control group perform global stretching exercises for approximately 20 minutes 3 times a week for 12 weeks.

Group Type PLACEBO_COMPARATOR

Stretching exercises

Intervention Type OTHER

Global stretching exercises will be performed for about 20 minutes 3 times a week for 12 weeks with supervision of specialized physiotherapists.

Interventions

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aerobic training

The intervention comprises fifty minutes of walking at anaerobic threshold plus stretching exercises 3 times a week for 12 weeks.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Martin F Simoes, MD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jamil Natour, Prof, MD

Role: STUDY_DIRECTOR

Federal University of São Paulo

Locations

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Universidade Federal de Sao Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 21540199 (View on PubMed)

Other Identifiers

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1325/08

Identifier Type: -

Identifier Source: org_study_id

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