Ankylosing SpondylitisNCT01351311
Resistance Training Exercise Using the Swiss Ball in Ankylosing Spondylitis
A study testing Exercise and Drug treatment in people with Ankylosing Spondylitis, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The aim of the present study is to assess the effectiveness of resistance training with swiss ball in the treatment of patients with ankylosing spondylitis. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- Exercise and Drug treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2011to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with established diagnosis of AS steinbrocker functional class I-II
- Basic medication stable for at least three months
- Agreed to participate and signed term of informed consent
Who cannot join
- Uncontrolled hypertension
- Coronary artery disease
- History of revascularization
- History of syncope or arrhythmias induced by exercise
- Decompensated diabetes mellitus
- Severe psychiatric illness
Show all 9Show fewer
- Fibromyalgia
- Another medical condition more disabling than AS
- History of exercise regular (at least 30 minutes 2 times per week)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Effectiveness of Resistance Training Exercise Using the Swiss Ball in Patients With Ankylosing Spondylitis
The aim of the present study is to assess the effectiveness of resistance training with swiss ball in the treatment of patients with ankylosing spondylitis.
Read the detailed description
A randomized, controlled, single-blind, prospective trial being conducted involving 54 patients with ankylosing spondylitis, selected from outpatient clinics - UNIFESP. They will be randomized in intervention group (n = 27) conduct training for muscle strengthening with the aid of the Swiss ball and in the control group (n = 27) did not undergo any intervention. Eight exercises will be conducted with intent to engage all muscle groups.
- Conditions
- Ankylosing Spondylitis
- Being tested
- Exercise, Drug treatment
- Keywords
- treatment, exercise, resistance training, swiss ball, functional capacity
- 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.
ExerciseOther
Also called Experimental group
Resistance Training exercise with swiss ball
Drug treatmentOther
Also called Control group
Drug treatment
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | Resistance exercise with swiss ball and drug treatment Receives: Other: Exercise |
| Control Group | Other | Drug treatment Receives: Other: Drug treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bath Ankylosing Spondylitis Functional Index (BASFI)
Functional capacity assessed by BASFI
Measured: 16 weeks
Secondary outcomes (10)
LIKERT SCALE
Likert scale by patients.
Measured: 16 weeks
1 REPETITION MAXIMUM TEST
muscle strength by testing an repetition maximum (1 RM)
Measured: 16 weeks
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
disease activity by BASDAI (The Bath Ankylosing Spondylitis Disease Activity Index)
Measured: 16 weeks
Bath Ankylosing Spondylitis Metrology Index (BASMI)
spinal mobility by BASMI
Measured: 16 weeks
erythrocyte sedimentation rate (ESR)
Measured: 16 weeks
6-MINUTE WALK TEST
Measured: 16 weeks
TIME UP AND GO TEST
Measured: 16 weeks
Short form-36 (SF-36)
quality of life by SF-36
Measured: 16 weeks
QUANTITY OF ANALGESICS AND ANTI-INFLAMATORY USED
Measured: 16 weeks
Health Assessment Questionnaire (HAQ) Health Assessment Questionnaire
Function
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2011 (estimated)
- Study startMar 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Marcelo Cardoso de Souza, Federal University of São Paulo
- Investigators
- Marcelo Souza, PT, MSc, Principal investigator, Federal University of São PauloFábio Jennings, MD, MSc, Study director, Federal University of São PauloJamil Natour, MD, PHD, Study chair, Division of Rheumatology, Federal University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01351311
- Sponsor's protocol ID
- FDAAAMC
- Status last verified
- Nov 2012
- First submitted
- 9 May 2011
- Last updated
- 30 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
American College of Sports Medicine. American College of Sports Medicine position stand. Progression models in resistance training for healthy adults. Med Sci Sports Exerc. 2009 Mar;41(3):687-708. doi: 10.1249/MSS.0b013e3181915670.
PubMed 19204579Souza MC, Jennings F, Morimoto H, Natour J. Swiss ball exercises improve muscle strength and walking performance in ankylosing spondylitis: a randomized controlled trial. Rev Bras Reumatol Engl Ed. 2017 Jan-Feb;57(1):45-55. doi: 10.1016/j.rbre.2016.09.009. Epub 2016 Oct 20. English, Portuguese.
PubMed 28137402
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Effectiveness of Resistance Training Exercise Using the Swiss Ball in Patients With Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT01351311
- Acronym / sponsor ID
- FDAAAMC
- Conditions
- Ankylosing Spondylitis
- Keywords
- treatment, exercise, resistance training, swiss ball, functional capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Mar 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 10 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present study is to assess the effectiveness of resistance training with swiss ball in the treatment of patients with ankylosing spondylitis.
Detailed description
A randomized, controlled, single-blind, prospective trial being conducted involving 54 patients with ankylosing spondylitis, selected from outpatient clinics - UNIFESP. They will be randomized in intervention group (n = 27) conduct training for muscle strengthening with the aid of the Swiss ball and in the control group (n = 27) did not undergo any intervention. Eight exercises will be conducted with intent to engage all muscle groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Other: ExerciseResistance exercise with swiss ball and drug treatment |
| Control Group | Other | Other: Drug treatmentDrug treatment |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with established diagnosis of AS steinbrocker functional class I-II
- Basic medication stable for at least three months
- Agreed to participate and signed term of informed consent
Key exclusion criteria (9 listed)
- Uncontrolled hypertension
- Coronary artery disease
- History of revascularization
- History of syncope or arrhythmias induced by exercise
- Decompensated diabetes mellitus
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 |
|---|---|---|
| ExerciseAlso: Experimental groupResistance Training exercise with swiss ball | Other | Exercise Group |
| Drug treatmentAlso: Control groupDrug treatment | Other | Control Group |
Primary outcome
Bath Ankylosing Spondylitis Functional Index (BASFI)
Time frame: 16 weeks
Functional capacity assessed by BASFI
10 secondary outcomes
LIKERT SCALE
Time frame: 16 weeks
1 REPETITION MAXIMUM TEST
Time frame: 16 weeks
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time frame: 16 weeks
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Time frame: 16 weeks
erythrocyte sedimentation rate (ESR)
Time frame: 16 weeks
6-MINUTE WALK TEST
Time frame: 16 weeks
TIME UP AND GO TEST
Time frame: 16 weeks
Short form-36 (SF-36)
Time frame: 16 weeks
QUANTITY OF ANALGESICS AND ANTI-INFLAMATORY USED
Time frame: 16 weeks
Health Assessment Questionnaire (HAQ) Health Assessment Questionnaire
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2012.
- Background: PubMed 19204579American College of Sports Medicine. American College of Sports Medicine position stand. Progression models in resistance training for healthy adults. Med Sci Sports Exerc. 2009 Mar;41(3):687-708. doi: 10.1249/MSS.0b013e3181915670.
- Derived from this study: PubMed 28137402Souza MC, Jennings F, Morimoto H, Natour J. Swiss ball exercises improve muscle strength and walking performance in ankylosing spondylitis: a randomized controlled trial. Rev Bras Reumatol Engl Ed. 2017 Jan-Feb;57(1):45-55. doi: 10.1016/j.rbre.2016.09.009. Epub 2016 Oct 20. English, Portuguese.
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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.
Marcelo Souza, PT, MSc principal investigator
Federal University of São Paulo
Fábio Jennings, MD, MSc study director
Federal University of São Paulo
Jamil Natour, MD, PHD study chair
Division of Rheumatology, Federal 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 Exercise and Drug treatment in people with Ankylosing Spondylitis, run by Federal University of São 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 3 inclusion and 9 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 30 Nov 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Bath Ankylosing Spondylitis Functional Index (BASFI) (time frame: 16 weeks). 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 NCT01351311, which also lists 2 linked publications.
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 30 Nov 2012.