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Exercise Therapy Program in Ankylosing Spondylitis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Andrea Lopes Gallinaro, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01690273
First received: September 18, 2012
Last updated: August 27, 2016
Last verified: August 2016
  Purpose
Mobility exercises are used in Ankylosing Spondylitis (AS) patients to preserve and restore axial mobility, but there are no data regarding a specific rehabilitation program that includes flexibility alone and its association with resistance exercises in AS patients with stable disease activity. So, we assessed the effects of two exercise programs in terms of mobility, functional capacity, quality of life and disease activity in AS patients. Methods. Fifty-five sedentary AS patients with a Bath Ankylosing Spondylitis Activity Index (BASDAI) <4 were included.

Condition Intervention
Ankylosing Spondylitis
Other: mobility exercise
Other: mobility and elastic resistance exercise

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: Effect of Two Exercise Therapy Program With and Without Elastic Resistance in Ankylosing Spondylitis Patients

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • FUNCTIONAL INDEX [ Time Frame: Baseline and 16 Weeks ] [ Designated as safety issue: Yes ]
    BASFI - Bath ankylosing spondylitis functional index. A scale from 0 to 10 (lower scores means better functional capacity), results are measured by mean and standard deviation.

  • Mobility Index [ Time Frame: Baseline and 16 weeks ] [ Designated as safety issue: Yes ]
    Bath ankylosing spondylitis motion index. A mean of five mobility measures committed by Ankylosing Spondylitis disease. Higher results means higher limitations in mobility (units of measure from 0 to 10)

  • Disease Activity Index [ Time Frame: Baseline and 16 Weeks ] [ Designated as safety issue: Yes ]
    BASDAI - Bath ankylosing spondylitis disease activity index. Scale from 0 to 6. Higher scores means worst disease activity. Numbers are expressed in average (SD)

  • Ankylosing Spondylitis Disease Activity Scale -Disease Activity [ Time Frame: Baseline and 16 Weeks ] [ Designated as safety issue: Yes ]
    Scores vary from 0 to 10, and higher than 4 scores are indicative of disease activity. Data are expressed by means and SD

  • Global Evaluation Self Reported [ Time Frame: Baseline and 16 Weeks ] [ Designated as safety issue: Yes ]
    Bath Ankylosing Spondylitis Global is a self reported global score varying from 0 to 10. Higher scores means worst health evaluation. Expressed by means and standard deviation.


Secondary Outcome Measures:
  • Thoracolumbar Mobility [ Time Frame: Baseline and 16 Weeks ] [ Designated as safety issue: Yes ]
    Thoracolumbar rotation Pavelka. Measured with a tape in centimeters. Higher number means better thoracolumbar rotation

  • Pain Scale [ Time Frame: Baseline and 16 Weeks ] [ Designated as safety issue: Yes ]
    Pain was evaluated in a visual analogue scale (VAS) from 0 to 10. higher scores means much pain. Data was expressed by means and standard deviation.

  • Stiffness Scale [ Time Frame: Baseline and 16 Weeks ] [ Designated as safety issue: Yes ]
    Stiffness was measured by an VAS varying from 0 to 10. Higher scores means worst stiffness. Data are expressed by mean and SD.

  • Short Form-12 (PCS) [ Time Frame: Baseline and 16 Weeks ] [ Designated as safety issue: Yes ]
    Quality of life was analyzed in a physical component score varying from 0 (lowest level of health) to 100 (highest level of health) scale. Data are expressed by mean and SD.

  • Short Form-12 (MCS) [ Time Frame: Baseline and 16 Weeks ] [ Designated as safety issue: Yes ]
    Quality of life was analyzed in a mental component score varying from 0 (lowest level of health) to 100 (highest level of health). Data are expressed by mean and SD.

  • MASES [ Time Frame: Baseline and 16 Weeks ] [ Designated as safety issue: Yes ]
    Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) score varying from 0 to 13. Where 0 is no painful point reported and 13 is all tender points reported as painful. Data are expressed by means and standard deviation

  • Chin-coronoid Distance [ Time Frame: Baseline and 16 Weeks ] [ Designated as safety issue: Yes ]
    lateral rotation of the head (chin-coronoid distance) was measured with a tape in centimeters. Highest score means better lateral rotation mobility. Data are expressed by means and standard deviation

  • Tragus-coronoid Distance [ Time Frame: Baseline and 16 Weeks ] [ Designated as safety issue: Yes ]
    lateral flexion of the head (tragus-coronoid distance) was measured with a tape in centimeters. Highest score means better lateral flexion mobility of the head.Data are expressed by means and standard deviation

  • Finger Floor Distance [ Time Frame: Baseline and 16 Weeks ] [ Designated as safety issue: Yes ]
    Distance between third finger of the hand and the floor while in lumbar flexion. It was measured with a tape in centimeters. Highest score means better torso flexion mobility. Data are expressed by means and standard deviation

  • Chest Expansion [ Time Frame: Baseline and 16 Weeks ] [ Designated as safety issue: Yes ]
    Chest expansion was measured with a tape in centimeters between inspiration and breathing exhaling. Highest score means better chest expansion. Data are expressed by means and standard deviation.


Enrollment: 55
Study Start Date: July 2012
Study Completion Date: November 2014
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: ankylosing spondylitis control
control group
Experimental: mobility exercise
mobility exercises
Other: mobility exercise
30 minutes, twice a week
Experimental: mobility and elastic resistance exercise
AS patients was submitted to a program mobility exercise plus elastic resistance exercises
Other: mobility and elastic resistance exercise
30 minutes, twice a week each exercises group. (total 1 hour)

Detailed Description:
The AS patients were randomly assigned into three groups, to receive a mobility exercise program (M) or mobility plus elastic resistance exercise program (M+R) or no exercise (C). The exercises group sessions were conducted twice per week for 16 weeks. This supervised program comprised 30 minutes of outdoor stretching and mobility exercises for the spine and limbs (M). After the flexibility program, M+R group carry out more 30 minutes of elastic resistance exercises. The mobility, disease activity and functional parameters were evaluated at baseline and after 16 weeks, with the evaluator blinded to the treatment group.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
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 Visual Analogue Scale ("VAS") over 8
  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: NCT01690273

Locations
Brazil
University of Sao Paulo
Sao Paulo, Brazil, 05403-010
Sponsors and Collaborators
University of Sao Paulo
Investigators
Study Chair: Ana Lucia Pinto, Phd University of Sao Paulo
  More Information

Publications:
Responsible Party: Andrea Lopes Gallinaro, MASTER, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01690273     History of Changes
Other Study ID Numbers: 8206212 
Study First Received: September 18, 2012
Results First Received: January 27, 2016
Last Updated: August 27, 2016
Health Authority: Brazil: Ethics Committee
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: paper is been written

Keywords provided by University of Sao Paulo:
exercise
mobility
strengthening
physiotherapy

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 December 07, 2016