Clinical trial NCT01351311: Resistance Training Exercise Using the Swiss Ball in Ankylosing Spondylitis
Official title: Assessment of Effectiveness of Resistance Training Exercise Using the Swiss Ball in Patients With Ankylosing Spondylitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankylosing Spondylitis
Keywords: treatment
exercise
resistance training
swiss ball
functional capacity
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2011-05-10
Enrollment: 60
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: The aim of the present study is to assess the effectiveness of resistance training with swiss ball in the treatment of patients with ankylosing spondylitis.

Detailed description: A randomized, controlled, single-blind, prospective trial being conducted involving 54 patients with ankylosing spondylitis, selected from outpatient clinics - UNIFESP. They will be randomized in intervention group (n = 27) conduct training for muscle strengthening with the aid of the Swiss ball and in the control group (n = 27) did not undergo any intervention. Eight exercises will be conducted with intent to engage all muscle groups.

Eligibility criteria: Inclusion Criteria:

* Patients with established diagnosis of AS steinbrocker functional class I-II
* Basic medication stable for at least three months
* Agreed to participate and signed term of informed consent

Exclusion Criteria:

* Uncontrolled hypertension
* Coronary artery disease
* History of revascularization
* History of syncope or arrhythmias induced by exercise
* Decompensated diabetes mellitus
* Severe psychiatric illness
* Fibromyalgia
* Another medical condition more disabling than AS
* History of exercise regular (at least 30 minutes 2 times per week)

Primary outcomes:
measure: Bath Ankylosing Spondylitis Functional Index (BASFI)
timeFrame: 16 weeks
Secondary outcomes:
measure: LIKERT SCALE
timeFrame: 16 weeks
measure: 1 REPETITION MAXIMUM TEST
timeFrame: 16 weeks
measure: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: 16 weeks
measure: Bath Ankylosing Spondylitis Metrology Index (BASMI)
timeFrame: 16 weeks
measure: erythrocyte sedimentation rate (ESR)
timeFrame: 16 weeks
measure: 6-MINUTE WALK TEST
timeFrame: 16 weeks
measure: TIME UP AND GO TEST
timeFrame: 16 weeks
measure: Short form-36 (SF-36)
timeFrame: 16 weeks
measure: QUANTITY OF ANALGESICS AND ANTI-INFLAMATORY USED
timeFrame: 16 weeks
measure: Health Assessment Questionnaire (HAQ) Health Assessment Questionnaire
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Marcelo Cardoso de Souza
Study officials:
affiliation: Federal University of São Paulo
name: Marcelo Souza, PT, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of São Paulo
name: Fábio Jennings, MD, MSc
role: STUDY_DIRECTOR
affiliation: Division of Rheumatology, Federal University of Sao Paulo
name: Jamil Natour, MD, PHD
role: STUDY_CHAIR
References:
citation: American College of Sports Medicine. American College of Sports Medicine position stand. Progression models in resistance training for healthy adults. Med Sci Sports Exerc. 2009 Mar;41(3):687-708. doi: 10.1249/MSS.0b013e3181915670.
citation: Souza MC, Jennings F, Morimoto H, Natour J. Swiss ball exercises improve muscle strength and walking performance in ankylosing spondylitis: a randomized controlled trial. Rev Bras Reumatol Engl Ed. 2017 Jan-Feb;57(1):45-55. doi: 10.1016/j.rbre.2016.09.009. Epub 2016 Oct 20. English, Portuguese.