Exercise Therapy Program in Ankylosing Spondylitis Patients

Not Applicable

Completed

• Conditions: Ankylosing Spondylitis
• Interventions: Other: mobility exercise; Other: mobility and elastic resistance exercise

• Registration Number: NCT01690273
• Lead Sponsor: University of Sao Paulo

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-09-18
• Study First Submitted QC: 2012-09-20
• Study First Posted: 2012-09-21
• Primary Completion: 2013-06
• Study Completion: 2014-11
• Results First Submitted: 2016-01-27
• Status Verified: 2016-08
• Results First Submitted QC: 2016-08-27
• Last Update Submitted: 2016-08-27
• Results First Posted: 2016-10-20
• Last Update Posted: 2016-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

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

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Exclusion Criteria

• Fibromyalgia
• Cardiovascular disease
• Pain Visual Analogue Scale ("VAS") over 8

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mobility exercise	mobility exercise	mobility exercises
mobility and elastic resistance exercise	mobility and elastic resistance exercise	AS patients was submitted to a program mobility exercise plus elastic resistance exercises

Primary Outcome Measures

Name	Time	Method
FUNCTIONAL INDEX	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.
Mobility Index	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)
Disease Activity Index	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)
Ankylosing Spondylitis Disease Activity Scale -Disease Activity	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
Global Evaluation Self Reported	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.

Secondary Outcome Measures

Name	Time	Method
Stiffness Scale	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.
Short Form-12 (PCS)	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.
Pain Scale	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.
Chin-coronoid Distance	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
Finger Floor Distance	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
Thoracolumbar Mobility	Baseline and 16 Weeks	Thoracolumbar rotation Pavelka. Measured with a tape in centimeters. Higher number means better thoracolumbar rotation
Short Form-12 (MCS)	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.
MASES	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
Tragus-coronoid Distance	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
Chest Expansion	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.

Trial Locations

Locations (1)

University of Sao Paulo; 🇧🇷 Sao Paulo, Brazil