Resistance Training Exercise Using the Swiss Ball in Ankylosing Spondylitis

November 29, 2012 updated by: Marcelo Cardoso de Souza, Federal University of São Paulo

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 04121001
        • Marcelo Cardoso de Souza

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Exercise Group
Resistance exercise with swiss ball and drug treatment
Other: Exercise
Resistance Training exercise with swiss ball
Other Names:
  • Experimental group
OTHER: Control Group
Drug treatment
Other: Drug treatment
Drug treatment
Other Names:
  • Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bath Ankylosing Spondylitis Functional Index (BASFI)
Time Frame: 16 weeks
Functional capacity assessed by BASFI
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LIKERT SCALE
Time Frame: 16 weeks
Likert scale by patients.
16 weeks
1 REPETITION MAXIMUM TEST
Time Frame: 16 weeks
muscle strength by testing an repetition maximum (1 RM)
16 weeks
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time Frame: 16 weeks
disease activity by BASDAI (The Bath Ankylosing Spondylitis Disease Activity Index)
16 weeks
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Time Frame: 16 weeks
spinal mobility by BASMI
16 weeks
erythrocyte sedimentation rate (ESR)
Time Frame: 16 weeks
16 weeks
6-MINUTE WALK TEST
Time Frame: 16 weeks
16 weeks
TIME UP AND GO TEST
Time Frame: 16 weeks
16 weeks
Short form-36 (SF-36)
Time Frame: 16 weeks
quality of life by SF-36
16 weeks
QUANTITY OF ANALGESICS AND ANTI-INFLAMATORY USED
Time Frame: 16 weeks
16 weeks
Health Assessment Questionnaire (HAQ) Health Assessment Questionnaire
Time Frame: 16 weeks
Function
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • Principal Investigator: Marcelo Souza, PT, MSc, Federal University of São Paulo
  • Study Director: Fábio Jennings, MD, MSc, Federal University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (ACTUAL)

November 1, 2012

Study Completion (ACTUAL)

November 1, 2012

Study Registration Dates

First Submitted

May 9, 2011

First Submitted That Met QC Criteria

May 9, 2011

First Posted (ESTIMATE)

May 10, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

November 30, 2012

Last Update Submitted That Met QC Criteria

November 29, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDAAAMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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