Resistance Training Exercise Using the Swiss Ball in Ankylosing Spondylitis

Ankylosing Spondylitis Clinical Trial

Official title:

Assessment of Effectiveness of Resistance Training Exercise Using the Swiss Ball in Patients With Ankylosing Spondylitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01351311
• Other study ID #: FDAAAMC
• Status: Completed
• Phase: N/A
• First received: May 9, 2011
• Last updated: November 29, 2012
• Start date: March 2011
• Est. completion date: November 2012

Study information

• Verified date: November 2012
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Other:
• Exercise
Resistance Training exercise with swiss ball
• Drug treatment
Drug treatment

Locations

Country	Name	City	State
Brazil	Marcelo Cardoso de Souza	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bath Ankylosing Spondylitis Functional Index (BASFI)	Functional capacity assessed by BASFI	16 weeks	Yes
Secondary	LIKERT SCALE	Likert scale by patients.	16 weeks	Yes
Secondary	1 REPETITION MAXIMUM TEST	muscle strength by testing an repetition maximum (1 RM)	16 weeks	Yes
Secondary	Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	disease activity by BASDAI (The Bath Ankylosing Spondylitis Disease Activity Index)	16 weeks	Yes
Secondary	Bath Ankylosing Spondylitis Metrology Index (BASMI)	spinal mobility by BASMI	16 weeks	Yes
Secondary	erythrocyte sedimentation rate (ESR)		16 weeks	Yes
Secondary	6-MINUTE WALK TEST		16 weeks	Yes
Secondary	TIME UP AND GO TEST		16 weeks	Yes
Secondary	Short form-36 (SF-36)	quality of life by SF-36	16 weeks	No
Secondary	QUANTITY OF ANALGESICS AND ANTI-INFLAMATORY USED		16 weeks	Yes
Secondary	Health Assessment Questionnaire (HAQ) Health Assessment Questionnaire	Function	16 weeks	No

External Links

•   Functional Training with swiss ball