Exercise Therapy Program in Ankylosing Spondylitis Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ankylosing Spondylitis

Intervention / Treatment
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* Other: mobility exercise
* Other: mobility and elastic resistance exercise


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: ankylosing spondylitis control<br>control group | |
| Experimental: mobility exercise<br>mobility exercises | Other: mobility exercise<br>* 30 minutes, twice a week<br>|
| Experimental: mobility and elastic resistance exercise<br>AS patients was submitted to a program mobility exercise plus elastic resistance exercises | Other: mobility and elastic resistance exercise<br>* 30 minutes, twice a week each exercises group. (total 1 hour)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FUNCTIONAL INDEX | 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 | 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 | 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 | 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 | 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 | Thoracolumbar rotation Pavelka. Measured with a tape in centimeters. Higher number means better thoracolumbar rotation | Baseline and 16 Weeks | 
| Pain Scale | 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 | 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) | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, mobility, strengthening, physiotherapy