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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ankylosing spondylitis control | No Intervention | control group | |
| mobility exercise | Experimental | mobility exercises |
|
| mobility and elastic resistance exercise | Experimental | AS patients was submitted to a program mobility exercise plus elastic resistance exercises |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mobility exercise | Other | 30 minutes, twice a week |
| |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ana Lucia Pinto, Phd | University of Sao Paulo | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Sao Paulo | São Paulo | São Paulo | 05403-010 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22218641 | Result | 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. |
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paper is been written
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Seventy patients did not accepted and 84 did not followed inclusion criteria. Fifty five were allocated into three groups after following the inclusion criteria.
Two hundred nine consecutive patients from the division of rheumatology outpatient clinic of the university hospital (Clinics Hospital of University Medicine School of Sao Paulo) diagnosed with AS according to the modified New York criteria, were invited to participate. Fifty Five individuals were randomly allocated into three groups
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| ID | Title | Description |
|---|---|---|
| FG000 | Ankylosing Spondylitis Control | control group, no intervention in ankylosing spondylitis patients |
| FG001 | Mobility in Ankylosing Spondylitis | mobility exercises mobility exercise: 30 minutes, twice a week |
| FG002 | Mobility and Elastic Resistance Exercise in AS | mobility, plus elastic resistance exercises mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ankylosing Spondylitis Control | Following a randomization, patients from control group stays during sixteen weeks only with medical treatment. |
| BG001 | Stretching in AS | stretching exercises stretching exercise: 30 minutes, twice a week for sixteen weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 16 Weeks |
|
during 16 weeks
A baseline evaluation was done and another after 16 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ankylosing Spondylitis Control | Following a randomization, patients from control group stays during sixteen weeks only with medical treatment. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrea Lopes Gallinaro; Researcher | Universidade Sao Paulo | 55112601 | 8022 | algallinaro@gmail.com |
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| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
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| ID | Term |
|---|---|
| D016059 | Range of Motion, Articular |
| ID | Term |
|---|---|
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D009142 | Musculoskeletal Physiological Phenomena |
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| mobility and elastic resistance exercise |
| Other |
30 minutes, twice a week each exercises group. (total 1 hour) |
|
| 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 |
| BG002 | Elastic Resistance Exercise in AS | stretching and elastic resistance exercises stretching and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour) for sixteen weeks. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
mobility and elastic resistance exercises mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour) |
|
|
|
| Primary | 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) | Posted | Mean | Standard Deviation | units on a scale from 0 to 10 | Baseline and 16 weeks |
|
|
|
|
| Primary | 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) | Posted | Mean | Standard Deviation | units on a scale | Baseline and 16 Weeks |
|
|
|
|
| Primary | 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 | Posted | Mean | Standard Deviation | units on a scale | Baseline and 16 Weeks |
|
|
|
|
| Primary | 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. | Posted | Median | Standard Deviation | units on a scale | Baseline and 16 Weeks |
|
|
|
|
| Secondary | Thoracolumbar Mobility | Thoracolumbar rotation Pavelka. Measured with a tape in centimeters. Higher number means better thoracolumbar rotation | Posted | Mean | Standard Deviation | Centimeters | Baseline and 16 Weeks |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 16 Weeks |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 16 Weeks |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 16 Weeks |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 16 Weeks |
|
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | Number of painful tender points | Baseline and 16 Weeks |
|
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | Centimeters | Baseline and 16 Weeks |
|
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | Centimeters | Baseline and 16 Weeks |
|
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | Centimeters | Baseline and 16 Weeks |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Centimeters | Baseline and 16 Weeks |
|
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Stretching in AS | stretching exercises stretching exercise: 30 minutes, twice a week for sixteen weeks. | 0 | 17 | 0 | 17 |
| EG002 | Elastic Resistance Exercise in AS | stretching and elastic resistance exercises stretching and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour) for sixteen weeks. | 0 | 20 | 0 | 20 |
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| D013122 |
| Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
| D001519 | Behavior |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
|
| No |
| Superiority or Other |
| Mixed Models Analysis | 0.0002 | No | Superiority or Other |
| Mixed Models Analysis | 1 | No | Superiority or Other |
| Mixed Models Analysis | 0.935 | No | Superiority or Other |
| Mixed Models Analysis | 0.876 | No | Superiority or Other |
|
| No |
| Superiority or Other |
| Mixed Models Analysis | 0.83 | No | Superiority or Other |
| Mixed Models Analysis | 0.989 | No | Superiority or Other |
| Mixed Models Analysis | 0.022 | No | Superiority or Other |
| Mixed Models Analysis | 0.119 | No | Superiority or Other |
|
| No |
| Superiority or Other |
| Mixed Models Analysis | 0.94 | No | Superiority or Other |
| Mixed Models Analysis | 0.213 | No | Superiority or Other |
| Mixed Models Analysis | 0.007 | No | Superiority or Other |
| Mixed Models Analysis | 0.900 | No | Superiority or Other |
|
| No |
| Superiority or Other |
| Mixed Models Analysis | 0.69 | No | Superiority or Other |
| Mixed Models Analysis | 0.874 | No | Superiority or Other |
| Mixed Models Analysis | 0.057 | No | Superiority or Other |
| Mixed Models Analysis | 0.526 | No | Superiority or Other |
|
| No |
| Superiority or Other |
| Mixed Models Analysis | 0.000 | No | Superiority or Other |
| Mixed Models Analysis | 0.889 | No | Superiority or Other |
| Mixed Models Analysis | 0.098 | No | Superiority or Other |
| Mixed Models Analysis | 0.645 | No | Superiority or Other |
|
| No |
| Superiority or Other |
| Mixed Models Analysis | 0.97 | No | Superiority or Other |
| Mixed Models Analysis | 1 | No | Superiority or Other |
| Mixed Models Analysis | 0.338 | No | Superiority or Other |
| Mixed Models Analysis | 0.476 | No | Superiority or Other |
|
| No |
| Superiority or Other |
| Mixed Models Analysis | 1 | No | Superiority or Other |
| Mixed Models Analysis | 1 | No | Superiority or Other |
| Mixed Models Analysis | 0.995 | No | Superiority or Other |
| Mixed Models Analysis | 0.985 | No | Superiority or Other |
|
| No |
| Superiority or Other |
| Mixed Models Analysis | 0.99 | No | Superiority or Other |
| Mixed Models Analysis | 0.999 | No | Superiority or Other |
| Mixed Models Analysis | 0.900 | No | Superiority or Other |
| Mixed Models Analysis | 0.739 | No | Superiority or Other |
|
| No |
| Superiority or Other |
| Mixed Models Analysis | 0.37 | No | Superiority or Other |
| Mixed Models Analysis | 0.618 | No | Superiority or Other |
| Mixed Models Analysis | 1 | No | Superiority or Other |
| Mixed Models Analysis | 0.689 | No | Superiority or Other |
|
| No |
| Superiority or Other |
| Mixed Models Analysis | 0.99 | No | Superiority or Other |
| Mixed Models Analysis | 0.999 | No | Superiority or Other |
| Mixed Models Analysis | 0.929 | No | Superiority or Other |
| Mixed Models Analysis | 0.980 | No | Superiority or Other |
|
| No |
| Superiority or Other |
| Mixed Models Analysis | 0.350 | No | Superiority or Other |
| Mixed Models Analysis | 0.997 | No | Superiority or Other |
| Mixed Models Analysis | 0.970 | No | Superiority or Other |
| Mixed Models Analysis | 0.999 | No | Superiority or Other |
|
| No |
| Superiority or Other |
| Mixed Models Analysis | 0.503 | No | Superiority or Other |
| Mixed Models Analysis | 0.814 | No | Superiority or Other |
| Mixed Models Analysis | 0.643 | No | Superiority or Other |
| Mixed Models Analysis | 0.999 | No | Superiority or Other |
|
| No |
| Superiority or Other |
| Mixed Models Analysis | 0.157 | No | Superiority or Other |
| Mixed Models Analysis | 0.835 | No | Superiority or Other |
| Mixed Models Analysis | 0.256 | No | Superiority or Other |
| Mixed Models Analysis | 0.935 | No | Superiority or Other |
|
| No |
| Superiority or Other |
| Mixed Models Analysis | 0.002 | No | Superiority or Other |
| Mixed Models Analysis | 0.993 | No | Superiority or Other |
| Mixed Models Analysis | 0.105 | No | Superiority or Other |
| Mixed Models Analysis | 0.335 | No | Superiority or Other |