Exercise Therapy Program in Ankylosing Spondylitis Patients
Primary Purpose
Ankylosing Spondylitis
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
mobility exercise
mobility and elastic resistance exercise
Sponsored by
About this trial
This is an interventional supportive care trial for Ankylosing Spondylitis focused on measuring exercise, mobility, strengthening, physiotherapy
Eligibility 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
Sites / Locations
- University of Sao Paulo
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
ankylosing spondylitis control
mobility exercise
mobility and elastic resistance exercise
Arm Description
control group
mobility exercises
AS patients was submitted to a program mobility exercise plus elastic resistance exercises
Outcomes
Primary Outcome Measures
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.
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)
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)
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
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.
Secondary Outcome Measures
Thoracolumbar Mobility
Thoracolumbar rotation Pavelka. Measured with a tape in centimeters. Higher number means better thoracolumbar rotation
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.
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.
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.
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.
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
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
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
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
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.
Full Information
NCT ID
NCT01690273
First Posted
September 18, 2012
Last Updated
August 27, 2016
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01690273
Brief Title
Exercise Therapy Program in Ankylosing Spondylitis Patients
Official Title
Effect of Two Exercise Therapy Program With and Without Elastic Resistance in Ankylosing Spondylitis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis
Keywords
exercise, mobility, strengthening, physiotherapy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ankylosing spondylitis control
Arm Type
No Intervention
Arm Description
control group
Arm Title
mobility exercise
Arm Type
Experimental
Arm Description
mobility exercises
Arm Title
mobility and elastic resistance exercise
Arm Type
Experimental
Arm Description
AS patients was submitted to a program mobility exercise plus elastic resistance exercises
Intervention Type
Other
Intervention Name(s)
mobility exercise
Intervention Description
30 minutes, twice a week
Intervention Type
Other
Intervention Name(s)
mobility and elastic resistance exercise
Intervention Description
30 minutes, twice a week each exercises group. (total 1 hour)
Primary Outcome Measure Information:
Title
FUNCTIONAL INDEX
Description
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.
Time Frame
Baseline and 16 Weeks
Title
Mobility Index
Description
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)
Time Frame
Baseline and 16 weeks
Title
Disease Activity Index
Description
BASDAI - Bath ankylosing spondylitis disease activity index. Scale from 0 to 6. Higher scores means worst disease activity. Numbers are expressed in average (SD)
Time Frame
Baseline and 16 Weeks
Title
Ankylosing Spondylitis Disease Activity Scale -Disease Activity
Description
Scores vary from 0 to 10, and higher than 4 scores are indicative of disease activity. Data are expressed by means and SD
Time Frame
Baseline and 16 Weeks
Title
Global Evaluation Self Reported
Description
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.
Time Frame
Baseline and 16 Weeks
Secondary Outcome Measure Information:
Title
Thoracolumbar Mobility
Description
Thoracolumbar rotation Pavelka. Measured with a tape in centimeters. Higher number means better thoracolumbar rotation
Time Frame
Baseline and 16 Weeks
Title
Pain Scale
Description
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.
Time Frame
Baseline and 16 Weeks
Title
Stiffness Scale
Description
Stiffness was measured by an VAS varying from 0 to 10. Higher scores means worst stiffness. Data are expressed by mean and SD.
Time Frame
Baseline and 16 Weeks
Title
Short Form-12 (PCS)
Description
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.
Time Frame
Baseline and 16 Weeks
Title
Short Form-12 (MCS)
Description
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.
Time Frame
Baseline and 16 Weeks
Title
MASES
Description
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
Time Frame
Baseline and 16 Weeks
Title
Chin-coronoid Distance
Description
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
Time Frame
Baseline and 16 Weeks
Title
Tragus-coronoid Distance
Description
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
Time Frame
Baseline and 16 Weeks
Title
Finger Floor Distance
Description
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
Time Frame
Baseline and 16 Weeks
Title
Chest Expansion
Description
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.
Time Frame
Baseline and 16 Weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana Lucia Pinto, Phd
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
University of Sao Paulo
City
Sao Paulo
ZIP/Postal Code
05403-010
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
paper is been written
Citations:
PubMed Identifier
22218641
Citation
Yigit S, Sahin Z, Demir SE, Aytac DH. Home-based exercise therapy in ankylosing spondylitis: short-term prospective study in patients receiving tumor necrosis factor alpha inhibitors. Rheumatol Int. 2013 Jan;33(1):71-7. doi: 10.1007/s00296-011-2344-6. Epub 2012 Jan 5.
Results Reference
result
Learn more about this trial
Exercise Therapy Program in Ankylosing Spondylitis Patients
We'll reach out to this number within 24 hrs