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Resistance Training Exercise Using the Swiss Ball in Ankylosing Spondylitis

Primary Purpose

Ankylosing Spondylitis

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Exercise
Drug treatment
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankylosing Spondylitis focused on measuring treatment, exercise, resistance training, swiss ball, functional capacity

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Marcelo Cardoso de Souza

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Exercise Group

Control Group

Arm Description

Resistance exercise with swiss ball and drug treatment

Drug treatment

Outcomes

Primary Outcome Measures

Bath Ankylosing Spondylitis Functional Index (BASFI)
Functional capacity assessed by BASFI

Secondary Outcome Measures

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

Full Information

First Posted
May 9, 2011
Last Updated
November 29, 2012
Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01351311
Brief Title
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

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis
Keywords
treatment, exercise, resistance training, swiss ball, functional capacity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise Group
Arm Type
Experimental
Arm Description
Resistance exercise with swiss ball and drug treatment
Arm Title
Control Group
Arm Type
Other
Arm Description
Drug treatment
Intervention Type
Other
Intervention Name(s)
Exercise
Other Intervention Name(s)
Experimental group
Intervention Description
Resistance Training exercise with swiss ball
Intervention Type
Other
Intervention Name(s)
Drug treatment
Other Intervention Name(s)
Control group
Intervention Description
Drug treatment
Primary Outcome Measure Information:
Title
Bath Ankylosing Spondylitis Functional Index (BASFI)
Description
Functional capacity assessed by BASFI
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
LIKERT SCALE
Description
Likert scale by patients.
Time Frame
16 weeks
Title
1 REPETITION MAXIMUM TEST
Description
muscle strength by testing an repetition maximum (1 RM)
Time Frame
16 weeks
Title
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Description
disease activity by BASDAI (The Bath Ankylosing Spondylitis Disease Activity Index)
Time Frame
16 weeks
Title
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Description
spinal mobility by BASMI
Time Frame
16 weeks
Title
erythrocyte sedimentation rate (ESR)
Time Frame
16 weeks
Title
6-MINUTE WALK TEST
Time Frame
16 weeks
Title
TIME UP AND GO TEST
Time Frame
16 weeks
Title
Short form-36 (SF-36)
Description
quality of life by SF-36
Time Frame
16 weeks
Title
QUANTITY OF ANALGESICS AND ANTI-INFLAMATORY USED
Time Frame
16 weeks
Title
Health Assessment Questionnaire (HAQ) Health Assessment Questionnaire
Description
Function
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcelo Souza, PT, MSc
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fábio Jennings, MD, MSc
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jamil Natour, MD, PHD
Organizational Affiliation
Division of Rheumatology, Federal University of Sao Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Marcelo Cardoso de Souza
City
Sao Paulo
ZIP/Postal Code
04121001
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
19204579
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.
Results Reference
background
PubMed Identifier
28137402
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.
Results Reference
derived
Links:
URL
http://www.treinamentofuncional.com.br/
Description
Functional Training with swiss ball

Learn more about this trial

Resistance Training Exercise Using the Swiss Ball in Ankylosing Spondylitis

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