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Completed

NCT Number: NCT01690273

Exercise Therapy Program 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.

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Key information

Conditions

Ankylosing Spondylitis Ankylosis Arthritis Axial Spondyloarthritis Behavior Bone Diseases Joint Diseases Motor Activity Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Sao Paulo

São Paulo, 05403-010, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mobility exercise

Other

30 minutes, twice a week

mobility and elastic resistance exercise

Other

30 minutes, twice a week each exercises group. (total 1 hour)

Primary outcomes

  1. 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.

  2. 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)

  3. 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)

  4. 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

  5. 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.

Secondary outcomes

  1. Thoracolumbar Mobility

    Time frame: Baseline and 16 Weeks

    Thoracolumbar rotation Pavelka. Measured with a tape in centimeters. Higher number means better thoracolumbar rotation

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Sep 21, 2012
Registry last updated
Oct 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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