Resistance Training Exercise Using the Swiss Ball in Ankylosing Spondylitis
This study has been completed.
Sponsor:
Federal University of São Paulo
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Marcelo Cardoso de Souza, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01351311
First received: May 9, 2011
Last updated: November 29, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Ankylosing Spondylitis |
Other: Exercise Other: Drug treatment |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Assessment of Effectiveness of Resistance Training Exercise Using the Swiss Ball in Patients With Ankylosing Spondylitis |
Resource links provided by NLM:
Further study details as provided by Federal University of São Paulo:
Primary Outcome Measures:
- Bath Ankylosing Spondylitis Functional Index (BASFI) [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]Functional capacity assessed by BASFI
Secondary Outcome Measures:
- LIKERT SCALE [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]Likert scale by patients.
- 1 REPETITION MAXIMUM TEST [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]muscle strength by testing an repetition maximum (1 RM)
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]disease activity by BASDAI (The Bath Ankylosing Spondylitis Disease Activity Index)
- Bath Ankylosing Spondylitis Metrology Index (BASMI) [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]spinal mobility by BASMI
- erythrocyte sedimentation rate (ESR) [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
- 6-MINUTE WALK TEST [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
- TIME UP AND GO TEST [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
- Short form-36 (SF-36) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]quality of life by SF-36
- QUANTITY OF ANALGESICS AND ANTI-INFLAMATORY USED [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
- Health Assessment Questionnaire (HAQ) Health Assessment Questionnaire [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]Function
| Enrollment: | 60 |
| Study Start Date: | March 2011 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Exercise Group
Resistance exercise with swiss ball and drug treatment
|
Other: Exercise
Resistance Training exercise with swiss ball
Other Name: Experimental group
|
|
Control Group
Drug treatment
|
Other: Drug treatment
Drug treatment
Other Name: Control group
|
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| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01351311
Locations
| Brazil | |
| Marcelo Cardoso de Souza | |
| Sao Paulo, Brazil, 04121001 | |
Sponsors and Collaborators
Federal University of São Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
| Principal Investigator: | Marcelo Souza, PT, MSc | Federal University of Sao Paulo |
| Study Director: | Fábio Jennings, MD, MSc | Federal University of Sao Paulo |
| Study Chair: | Jamil Natour, MD, PHD | Division of Rheumatology, Federal University of Sao Paulo |
More Information
Additional Information:
Publications:
| Responsible Party: | Marcelo Cardoso de Souza, MsC, Federal University of São Paulo |
| ClinicalTrials.gov Identifier: | NCT01351311 History of Changes |
| Other Study ID Numbers: | FDAAAMC |
| Study First Received: | May 9, 2011 |
| Last Updated: | November 29, 2012 |
| Health Authority: | Brazil: Ethics Committee |
Keywords provided by Federal University of São Paulo:
|
treatment exercise resistance training swiss ball functional capacity |
Additional relevant MeSH terms:
|
Spondylitis Spondylitis, Ankylosing Bone Diseases, Infectious Infection Bone Diseases Musculoskeletal Diseases |
Spinal Diseases Spondylarthropathies Spondylarthritis Ankylosis Joint Diseases Arthritis |
ClinicalTrials.gov processed this record on May 19, 2013