Resistance Training Exercise Using the Swiss Ball in Ankylosing Spondylitis

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014