Hypermobility SyndromePhase 2NCT02869373
Spinal Stabilization Exercise Effects in Hypermobility
A Phase 2 study testing spinal stabilizaton exercise in people with Hypermobility Syndrome, run by Ataturk Training and Research Hospital.
Trial summary
The aim of this study is to investigate the effects of an 8-week lumbar spinal stabilization exercise program on pain, trunk muscle endurance and postural stability in women with benign joint hypermobility syndrome Read more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- Conditions the study is for
- Hypermobility Syndrome
- What is being tested?
- spinal stabilizaton exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Oct 2015
- Phase
- Phase 2
- 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 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- volunteers in an age range of 18 to 30,
- being women,
- having benign joint hypermobility syndrome diagnosed according to the Brighton criteria,
- having no contraindication to join an exercise program.
Who cannot join
- having rheumatologic or neurologic diseases,
- any other pathology involving the musculoskeletal system-history of fractures, joint dislocations, sprains and strains,
- associated connective tissue disorders including Marfan syndrome, Ehlers-Danlos syndrome, osteogenesis imperfecta,
- severe psychological disorders,
- being pregnant,
- intervention including exercise or physical therapy in the last 3 months.
About this study
Official title: Assistant Professor
The aim of this study is to investigate the effects of an 8-week lumbar spinal stabilization exercise program on pain, trunk muscle endurance and postural stability in women with benign joint hypermobility syndrome
- Conditions
- Hypermobility Syndrome
- Being tested
- spinal stabilizaton exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal stabilizaton exerciseBehavioural
In Exercise group, spinal stabilization exercise program was carried out 3 days a week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | spinal stabilization exercise program was applied Receives: Behavioral: spinal stabilizaton exercise |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in musculoskeletal pain intensity as measured by Visual Analog Scale
Measured: Change from baseline musculoskeletal pain intensity at 8 weeks
Secondary outcomes (2)
Change in trunk muscle endurance as measued with McGill's trunk muscle endurance tests
Measured: Change from baseline trunk muscle endurance at 8 weeks
Change in postural stability as measured with Biodex Balance System SD
Measured: Change from baseline postural stability at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startApr 2015
- Primary completionJul 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypermobility SyndromeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyda TOPRAK CELENAY, Ataturk Training and Research Hospital
- Investigators
- Seyda TOPRAK CELENAY, Study director, Ankara Yildirim Beyazıt UniversityDerya OZER KAYA, Principal investigator, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02869373
- Sponsor's protocol ID
- 2015-64/82
- Status last verified
- Aug 2016
- First submitted
- 12 Aug 2016
- Last updated
- 16 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assistant Professor
- ClinicalTrials.gov ID
- NCT02869373
- Acronym / sponsor ID
- 2015-64/82
- Conditions
- Hypermobility Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Ataturk Training and Research HospitalUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 16 Aug 2016 (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 this study is to investigate the effects of an 8-week lumbar spinal stabilization exercise program on pain, trunk muscle endurance and postural stability in women with benign joint hypermobility syndrome
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: spinal stabilizaton exercisespinal stabilization exercise program was applied |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- volunteers in an age range of 18 to 30,
- being women,
- having benign joint hypermobility syndrome diagnosed according to the Brighton criteria,
- having no contraindication to join an exercise program.
Key exclusion criteria (6 listed)
- having rheumatologic or neurologic diseases,
- any other pathology involving the musculoskeletal system-history of fractures, joint dislocations, sprains and strains,
- associated connective tissue disorders including Marfan syndrome, Ehlers-Danlos syndrome, osteogenesis imperfecta,
- severe psychological disorders,
- being pregnant,
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 |
|---|---|---|
| spinal stabilizaton exerciseIn Exercise group, spinal stabilization exercise program was carried out 3 days a week for 8 weeks. | Behavioural | Exercise |
Primary outcome
Change in musculoskeletal pain intensity as measured by Visual Analog Scale
Time frame: Change from baseline musculoskeletal pain intensity at 8 weeks
2 secondary outcomes
Change in trunk muscle endurance as measued with McGill's trunk muscle endurance tests
Time frame: Change from baseline trunk muscle endurance at 8 weeks
Change in postural stability as measured with Biodex Balance System SD
Time frame: Change from baseline postural stability at 8 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 16 Aug 2016.
Related trials for Hypermobility Syndrome
Not yet recruitingPhase 1/2
Regenerative Medicine for Joint Hypermobility and Instability
Ehlers-Danlos Syndrome Hypermobility Type (hEDS), Ehlers-Danlos Syndrome (EDS)
Active, not recruiting
Exercise in Patients With Hypermobile Joints and Knee Pain
Hypermobility, Joint, Hypermobility Syndrome
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Hamstring Strengthening in Hypermobile Conditions
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Enrolling by invitation
Functional and Performance Determinants in Climbers: Examining the Role of Mobility, Stability, and Fatigue Across Proficiency Levels
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Not yet recruiting
Dynamic Lycra Garments for Hip Dysplasia Feasibility Study
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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.
Seyda TOPRAK CELENAY study director
Ankara Yildirim Beyazıt University
Derya OZER KAYA principal investigator
Izmir Katip Celebi University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing spinal stabilizaton exercise in people with Hypermobility Syndrome, run by Ataturk Training and Research Hospital.
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 6 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 16 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in musculoskeletal pain intensity as measured by Visual Analog Scale (time frame: Change from baseline musculoskeletal pain intensity at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Aug 2016; AzTrials last refreshed its copy on 31 Oct 2026.