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Effect Of Strengthening Exercise In Patients With Ankylosing Spondylitis

This study is currently recruiting participants.
Verified September 2012 by University of Sao Paulo
Sponsor:
Information provided by (Responsible Party):
Andrea Lopes Gallinaro, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01690273
First received: September 18, 2012
Last updated: September 20, 2012
Last verified: September 2012
History of Changes
  Purpose

To evaluate the effects of exercise in patients with ankylosing spondylitis using thera-bands at quality of life, functional capacity in patients with BASDAI lower than 4.Evaluate 50 patients with the diagnose of ankylosing spondylitis according to the criteria of the American College of rheumatology provenient from FMUSP at Clinical Hospital of São Paulo.


Condition Intervention
Ankylosing Spondylitis
 Other: stretching exercise
Other: strengthening group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: EVALUATION OF THE EFFECT OF TWO EXERCISES PROGRAMS WITH AND WITHOUT MUSCULAR STRENGTHETING WITH ELASTIC BANDS IN PATIENTS WITH ANKYLOSING SPONDYLITIS

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • FUNCTIONAL INDEX [ Time Frame: sixteen weeks ] [ Designated as safety issue: Yes ]
    BASFI - Bath ankylosyng spondylitis functional index


Secondary Outcome Measures:
  • BASMI [ Time Frame: sixteen weeks ] [ Designated as safety issue: Yes ]
    Bath ankylosing spondylitis motion index


Other Outcome Measures:
  • patient evaluation quality of life [ Time Frame: sixteen weeks ] [ Designated as safety issue: Yes ]
    BAS-G, ASQOL, SF 12

  • flexibility [ Time Frame: sixteen weeks ] [ Designated as safety issue: Yes ]
    FINGER TO FLOOR DISTANCE, intermaleolar distance,head lateral rotation , head lateral flexion, chest expansibility, Pavelka toracolumbar rotation.


Estimated Enrollment: 50
Study Start Date: July 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: ankylosing spondylitis control
Active Comparator: ankylosing spondylitis
stretching exercises,30 minutes, twice a week.
 Other: stretching exercise
30 minutes, twice a week
Experimental: ankylosing spondylitis exercise
strenghtening exercises,30 minutes, twice a week.
 Other: strengthening group
30 minutes, twice a weeks, using thera-bands

Detailed Description:

The evaluation complies BASFI, BASDAI, BASMI,BAS-G, ASQOL, SF 12,MASES, finger to floor distance, intermaleolar distance, lateral rotation of head, lateral flexion of the head, stiffness VAS, chest expasibility, Pavelka evaluation. All patients are allocatted randomly into 3 groups. One control with no exercise, group 1 with stretching exercise ( 30 minutes) and group 2 with stretching and strenghtening exercise (30 minutes+minutes)

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ankylosing spondylitis patient
  • Basdai index lower than 4
  • Physical inactive
  • Functional class I to III

Exclusion Criteria:

  • Fibromyalgia
  • Cardiovascular disease
  • Pain VAS over 8
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01690273

Locations
Brazil
University of Sao Paulo Recruiting
Sao Paulo, Brazil, 05403-010
Contact: ANDREA LOPES GALLINARO, MAESTER     55-11-92420936     ALGALLINARO@TERRA.COM.BR    
Contact: ANA LUCIA DE SÁ PINTO, PHD     55-11-2661-8022     ANALUCIA@MOVE.MED.BR    
Sub-Investigator: CELIO ROBERTO GONÇALVES, PHD            
Sub-Investigator: CARLA GONÇALVES SAAD, PHD            
Sub-Investigator: ANA LUCIA DE SÁ PINTO, PHD            
Sponsors and Collaborators
University of Sao Paulo
  More Information

Publications:

Responsible Party: Andrea Lopes Gallinaro, MAESTER, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01690273     History of Changes
Other Study ID Numbers: 8206212
Study First Received: September 18, 2012
Last Updated: September 20, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
exercise
stretching
strengthening

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 23, 2013