Exercise Therapy Program in Ankylosing Spondylitis Patients

August 27, 2016 updated by: Andrea Lopes Gallinaro, University of Sao Paulo

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

55

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, 05403-010
        • University of Sao Paulo

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FUNCTIONAL INDEX
Time Frame: Baseline and 16 Weeks
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.
Baseline and 16 Weeks
Mobility Index
Time Frame: Baseline and 16 weeks
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)
Baseline and 16 weeks
Disease Activity Index
Time Frame: Baseline and 16 Weeks
BASDAI - Bath ankylosing spondylitis disease activity index. Scale from 0 to 6. Higher scores means worst disease activity. Numbers are expressed in average (SD)
Baseline and 16 Weeks
Ankylosing Spondylitis Disease Activity Scale -Disease Activity
Time Frame: Baseline and 16 Weeks
Scores vary from 0 to 10, and higher than 4 scores are indicative of disease activity. Data are expressed by means and SD
Baseline and 16 Weeks
Global Evaluation Self Reported
Time Frame: Baseline and 16 Weeks
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.
Baseline and 16 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thoracolumbar Mobility
Time Frame: Baseline and 16 Weeks
Thoracolumbar rotation Pavelka. Measured with a tape in centimeters. Higher number means better thoracolumbar rotation
Baseline and 16 Weeks
Pain Scale
Time Frame: Baseline and 16 Weeks
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.
Baseline and 16 Weeks
Stiffness Scale
Time Frame: Baseline and 16 Weeks
Stiffness was measured by an VAS varying from 0 to 10. Higher scores means worst stiffness. Data are expressed by mean and SD.
Baseline and 16 Weeks
Short Form-12 (PCS)
Time Frame: Baseline and 16 Weeks
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.
Baseline and 16 Weeks
Short Form-12 (MCS)
Time Frame: Baseline and 16 Weeks
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.
Baseline and 16 Weeks
MASES
Time Frame: Baseline and 16 Weeks
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
Baseline and 16 Weeks
Chin-coronoid Distance
Time Frame: Baseline and 16 Weeks
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
Baseline and 16 Weeks
Tragus-coronoid Distance
Time Frame: Baseline and 16 Weeks
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
Baseline and 16 Weeks
Finger Floor Distance
Time Frame: Baseline and 16 Weeks
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
Baseline and 16 Weeks
Chest Expansion
Time Frame: Baseline and 16 Weeks
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.
Baseline and 16 Weeks

Collaborators and Investigators

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

Sponsor

University of Sao Paulo

Investigators

  • Study Chair: Ana Lucia Pinto, Phd, University of Sao 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

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

July 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

September 18, 2012

First Submitted That Met QC Criteria

September 20, 2012

First Posted (Estimate)

September 21, 2012

Study Record Updates

Last Update Posted (Estimate)

October 20, 2016

Last Update Submitted That Met QC Criteria

August 27, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8206212

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

paper is been written

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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