Ankylosing SpondylitisNCT01690273
Exercise Therapy Program in Ankylosing Spondylitis Patients
A study testing mobility exercise and mobility and elastic resistance exercise in people with Ankylosing Spondylitis, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- mobility exercise and mobility and elastic resistance exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2012to Nov 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Ankylosing spondylitis patient
- Basdai index lower than 4
- Physical inactive
- Functional class I to III
Who cannot join
- Fibromyalgia
- Cardiovascular disease
- Pain Visual Analogue Scale ("VAS") over 8
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Two Exercise Therapy Program With and Without Elastic Resistance 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.
Read the 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.
- Conditions
- Ankylosing Spondylitis
- Being tested
- mobility exercise, mobility and elastic resistance exercise
- Keywords
- exercise, mobility, strengthening, physiotherapy
- Medical subject headings
- Spondylitis, Ankylosing, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobility exerciseOther
30 minutes, twice a week
mobility and elastic resistance exerciseOther
30 minutes, twice a week each exercises group. (total 1 hour)
| Study group | Role | What they receive |
|---|---|---|
| ankylosing spondylitis control | No intervention | control group |
| mobility exercise | Experimental | mobility exercises Receives: Other: mobility exercise |
| mobility and elastic resistance exercise | Experimental | AS patients was submitted to a program mobility exercise plus elastic resistance exercises Receives: Other: mobility and elastic resistance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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.
Measured: Baseline and 16 Weeks
Secondary outcomes (10)
Thoracolumbar Mobility
Thoracolumbar rotation Pavelka. Measured with a tape in centimeters. Higher number means better thoracolumbar rotation
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Baseline and 16 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startJul 2012
- Primary completionJun 2013
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Lopes Gallinaro, University of Sao Paulo
- Investigators
- Ana Lucia Pinto, Phd, Study chair, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01690273
- Sponsor's protocol ID
- 8206212
- Status last verified
- Aug 2016
- First submitted
- 18 Sep 2012
- Last updated
- 20 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: paper is been written
Publications
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.
PubMed 22218641
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Two Exercise Therapy Program With and Without Elastic Resistance in Ankylosing Spondylitis Patients
- ClinicalTrials.gov ID
- NCT01690273
- Acronym / sponsor ID
- 8206212
- Conditions
- Ankylosing Spondylitis
- Keywords
- exercise, mobility, strengthening, physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 21 Sep 2012 (estimated)
- Results
- Posted 20 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ankylosing spondylitis control | No intervention | –control group |
| mobility exercise | Experimental | Other: mobility exercisemobility exercises |
| mobility and elastic resistance exercise | Experimental | Other: mobility and elastic resistance exerciseAS patients was submitted to a program mobility exercise plus elastic resistance exercises |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Ankylosing spondylitis patient
- Basdai index lower than 4
- Physical inactive
- Functional class I to III
Key exclusion criteria (3 listed)
- Fibromyalgia
- Cardiovascular disease
- Pain Visual Analogue Scale ("VAS") over 8
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mobility exercise30 minutes, twice a week | Other | mobility exercise |
| mobility and elastic resistance exercise30 minutes, twice a week each exercises group. (total 1 hour) | Other | mobility and elastic resistance exercise |
Primary outcome
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.
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)
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)
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
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.
10 secondary outcomes
Thoracolumbar Mobility
Time frame: Baseline and 16 Weeks
Pain Scale
Time frame: Baseline and 16 Weeks
Stiffness Scale
Time frame: Baseline and 16 Weeks
Short Form-12 (PCS)
Time frame: Baseline and 16 Weeks
Short Form-12 (MCS)
Time frame: Baseline and 16 Weeks
MASES
Time frame: Baseline and 16 Weeks
Chin-coronoid Distance
Time frame: Baseline and 16 Weeks
Tragus-coronoid Distance
Time frame: Baseline and 16 Weeks
Finger Floor Distance
Time frame: Baseline and 16 Weeks
Chest Expansion
Time frame: Baseline and 16 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22218641Yigit 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.
- Individual participant dataSharing planned: Yes. paper is been written
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Lucia Pinto, Phd study chair
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mobility exercise and mobility and elastic resistance exercise in people with Ankylosing Spondylitis, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FUNCTIONAL INDEX (time frame: Baseline and 16 Weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01690273, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2016.