Clinical trial NCT01586650: Effects of Aerobic Training in Patients With Ankylosing Spondylitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ankylosing Spondylitis
Keywords: ankylosing spondylitis
aerobic exercise
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2012-04-27
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in BASFI
timeFrame: Baseline, after 6, 12 and 24 weeks.
Secondary outcomes:
measure: Change in BASDAI
timeFrame: Baseline, after 6, 12 and 24 weeks.
measure: Change in BASMI
timeFrame: Baseline, after 6, 12 and 24 weeks.
measure: Change in HAQ-S
timeFrame: Baseline, after 6, 12 and 24 weeks.
measure: Incremental cardiopulmonary exercise testing protocol by treadmill
timeFrame: Baseline and after 12 weeks.
measure: Levels of C reactive protein and erythrocyte rate sedimentation
timeFrame: Baseline, after 6. 12 and 24 weeks
measure: Levels of cytokines- TNF, IL10, IL6 and IL1.
timeFrame: Baseline and after 12 weeks.
measure: Change in the Six minute walking test
timeFrame: Baseline, after 6, 12 and 24 weeks.
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Universidade Federal de Sao Paulo
Study officials:
affiliation: Federal University of São Paulo
name: Jamil Natour, Prof, MD
role: STUDY_DIRECTOR
References:
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.