Hypermobile Ehlers-Danlos SyndromeNCT07118865
Online Pilates Exercise for People With Hypermobility
A study testing Online Pilates exercise in people with Hypermobile Ehlers-Danlos Syndrome and Hypermobile Spectrum Disorder, run by Clarkson University at 1 site in United States.
Trial summary
People with hypermobile Ehlers-Danlos Syndrome/Hypermobility Spectrum Disorder (hEDS/HSD) often have pain, coordination problems, and low tolerance to activity and exercise. There is a publicly available on-line, independent Pilates program designed specifically for this population. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypermobile Ehlers-Danlos Syndrome, Hypermobile Spectrum Disorder
- What is being tested?
- Online Pilates exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2019to 21 Mar 2021
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- i. Have some form of Hypermobility Spectrum Disorders or hypermobile Ehlers-Danlos syndrome (HSD/hEDS) diagnosed by any health care provider; this would include individuals diagnosed with Joint Hypermobility Syndrome using the pre-2017 diagnostic criteria.
- Able to read the English language and understand spoken English. iii. Willing to try to do Pilates using the 25 minute on-line training videos at least 3 times per week, unless they experience some adverse event or illness that prevents them from safely participating.
Who cannot join
- i. Medical restrictions (such as recent and healing surgery, fractures, comorbidities such as severe rheumatoid arthritis or neurological conditions, etc.) that prevent them from safely doing gentle exercise lying down on the floor, sitting, and standing.
- Inability to safely stand (with or without using upper extremity for balance) for 10 consecutive minutes.
- Recent injuries or changes in status that are not stable. This will be defined as "A significant change in your wellness due to recent injury or new symptoms in the past month that result in your wellness during the past month being very different from the past 5 months. Flare episodes that are typical for you will not prevent you from participating at this time." iv. Significantly changed treatment approach or medication within the past 3 months or be expecting to change their treatment program (including medication changes) during the study. This would make it difficult for us to know if changes are due to the Pilates class or the change in their treatment program. However, we understand that their health status may change such that they need to change their health care routine for physical and mental health.
- Currently receiving regular rehabilitation such as physical therapy, or having received physical therapy (PT) or a similar movement-based therapy (such as such as Pilates, Feldenkrais, Tai Chi, qigung, yoga) in the past 3 months. Individuals who continue to do exercises from any of these sources are not excluded, as these individuals should be stable on their current routine.
- Currently doing more than 30 minutes/week of Pilates exercise.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clarkson University. Entire study is online, no physical site used.
Potsdam, New York, 13699
About this study
Official title: Assessing the Impact of Internet-Guided Pilates Training on People With Hypermobility
People with hypermobile Ehlers-Danlos Syndrome/Hypermobility Spectrum Disorder (hEDS/HSD) often have pain, coordination problems, and low tolerance to activity and exercise. There is a publicly available on-line, independent Pilates program designed specifically for this population. This research project proposes to measure pain, function, and common symptoms in individuals before and after 8 weeks of using this on-line Pilates module, and will follow up 6 months later, and compare to an 8-week wait-list control group.
Read the detailed description
The intervention is provided through an on-line Pilates module commercially available at https://jeanniedibon.com/strengthen-your-hypermobile-core/. "Strengthen Your Hypermobile Core" has 5 modules. Subjects will be asked to complete the modules in order, as the modules build upon one another. However, subjects may repeat any modules at any time, with the goal of completing all 5 modules within the 8 week period. This allows subjects the flexibility to customize their participation by using the modules they feel are most helpful. Users who typically access this Pilates course have this same flexibility so, while it adds variability to the intervention, it better reflects how the program is actually used.
Subjects will be asked to do their Pilates practice while watching the videos (not from memory) to ensure that they are performing techniques optimally. Each module lasts 25 minutes, but includes some resting activities so modules are not vigorous or fatiguing for most people. Nonetheless, subjects will be instructed to omit activities that they feel they cannot do safely. Subjects can pause a session to add more rest breaks, if needed, or stop and complete a session later. Subjects will commit to doing 3 Pilates modules per week, for a total of 75-90 minutes/week (depending on the exact length of the modules they do).
Subjects will complete questionnaires before starting the on-line Pilates modules. Completing these questionnaires on SurveyMonkey is likely to take 30-45 minutes.
The study initially aimed to include a total of 100 participants, but more than 800 signed up within the first 2 weeks, and another 200 over the following months. The design was therefore modified to have the first 300 participants start the Pilates immediately, and the remaining participants begin after an 8-week waiting period. In addition to adding a control group, the wait-list prevented us from having to turn people away from free access to the exercise program, and from our being overwhelmed by too many participants. Because subjects were not randomly assigned and the intervention could not be directly monitored, the study is a pragmatic clinical trial.
- Being tested
- Online Pilates exercise
- Keywords
- hypermobile Ehlers-Danlos Syndrome, hypermobility spectrum disorder, pilates, pragmatic clinical trial
- Medical subject headings
- Ehlers-Danlos syndrome type 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Pilates exerciseOther
Participants will be asked to do their Pilates practice while watching the videos (not from memory) to ensure that they are performing techniques optimally. Each module lasts 25 minutes, but includes some resting activities so modules are not vigorous or fatiguing for most people. Nonetheless, subjects will be instructed to omit activities that they feel they cannot do safely. Participants can pause a session to add more rest breaks, if needed, or stop and complete a session later. Participants will attempt to do 3 Pilates modules per week, for a total of 75-90 minutes/week (depending on the exact length of the modules they do).
| Study group | Role | What they receive |
|---|---|---|
| Pilates exercise | Experimental | Pilates exercise, Trying to do 25 min of Pilates 3x/week for 8 wks Receives: Other: Online Pilates exercise |
| Wait-list control | No intervention | Waiting 8 weeks without starting Pilates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bristol Impact of Hypermobility questionnaire (BIoH)
The BIoH is a 55 item questionnaire that asks about pain, fatigue, joint instability, function, self-efficacy and attitudes about having hypermobility. It is the only outcome measure specifically validated for hypermobility-related conditions, and it is recommended by the international Common Data Elements initiative, whose goal is to encourage Ehlers-Danlos syndrome (EDS) researchers to use consistent outcome measures. (Palmer, 2017)
Measured: Enrollment, after 8 weeks of Pilates, 6 months after completed Pilates.
Secondary outcomes (3)
Tampa Scale of Kinesiophobia (TSK)
Kinesiophobia will be assessed through the Tampa Scale of Kinesiophobia, short form (TSK-11), which is an 11-question survey asking about fear of movement and fear of injury.(Woby, 2005) The Tampa Scale of Kinesiophobia is one of the recommended Common Data Elements for EDS.
Measured: Enrollment, after 8 weeks of Pilates, 6 months after completing Pilates.
The Revised Body Awareness Rating Questionnaire (R-BARQ)
The Revised Body Awareness Rating Questionnaire (R-BARQ) includes 12 questions that ask about body awareness, response to discomfort, breathing patters, and physical response to stress.(Dragesund, 2018) This tool may provide insight into the mechanism by which functional improvements are achieved, by correlating functional improvements with improved body awareness, relaxation, effective breathing, etc.
Measured: Enrollment, after 8 weeks of Pilates, 6 months after completing Pilates.
The International Physical Activity Questionnaire Short Form
The International Physical Activity Questionnaire Short Form is a validated survey assessing physical activity during work, sport, and leisure time. (Booth, 2000)
Measured: Time Frame: Enrollment, after 8 weeks of Pilates, 6 months after completing Pilates.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start15 Sep 2019
- Primary completion21 Mar 2021
- Study completion21 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hypermobile Ehlers-Danlos 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study was a pragmatic clinical trial with an intervention group and a wait-list control group. The groups were assigned sequentially and not randomly: the first group of about 300 subjects was allowed to start the exercise program immediately, while the rest became the wait-list control.
- Masking
- None (open label)
- Enrolment
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clarkson University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leslie Russek, Clarkson University
- Investigators
- Leslie N. Russek, Principal investigator, Professor Emeritus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07118865
- Sponsor's protocol ID
- 19-48.3
- Status last verified
- Jun 2026
- First submitted
- 30 Jul 2025
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Hope to share data.
Publications
Booth M. Assessment of physical activity: an international perspective. Res Q Exerc Sport. 2000 Jun;71(2 Suppl):S114-20. No abstract available.
PubMed 10925833Dragesund T, Strand LI, Grotle M. The Revised Body Awareness Rating Questionnaire: Development Into a Unidimensional Scale Using Rasch Analysis. Phys Ther. 2018 Feb 1;98(2):122-132. doi: 10.1093/ptj/pzx111.
PubMed 29096009Palmer S, Cramp F, Lewis R, Gould G, Clark EM. Development and initial validation of the Bristol Impact of Hypermobility questionnaire. Physiotherapy. 2017 Jun;103(2):186-192. doi: 10.1016/j.physio.2016.04.002. Epub 2016 May 4.
PubMed 27567344Woby SR, Roach NK, Urmston M, Watson PJ. Psychometric properties of the TSK-11: a shortened version of the Tampa Scale for Kinesiophobia. Pain. 2005 Sep;117(1-2):137-44. doi: 10.1016/j.pain.2005.05.029.
PubMed 16055269Russek LN, Di Bon J, Herbland A, Vivlamore Zion Higgins C, Jandrew TR, Adams AM, Simmonds J. An Online Pilates Program for People with Hypermobility: A Pragmatic Clinical Trial Looking at Function, Interoception, Kinesiophobia, and Physical Activity Levels. J Multidiscip Healthc. 2026 Feb 16;19:564972. doi: 10.2147/JMDH.S564972. eCollection 2026.
PubMed 41737369
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of Internet-Guided Pilates Training on People With Hypermobility
- ClinicalTrials.gov ID
- NCT07118865
- Acronym / sponsor ID
- 19-48.3
- Keywords
- hypermobile Ehlers-Danlos Syndrome, hypermobility spectrum disorder, pilates, pragmatic clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- Clarkson UniversityUniversity, hospital or other
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 21 Mar 2021 (actual)
- Study completion
- 21 Mar 2021 (actual)
- First posted
- 12 Aug 2025 (actual)
- 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.
People with hypermobile Ehlers-Danlos Syndrome/Hypermobility Spectrum Disorder (hEDS/HSD) often have pain, coordination problems, and low tolerance to activity and exercise. There is a publicly available on-line, independent Pilates program designed specifically for this population. This research project proposes to measure pain, function, and common symptoms in individuals before and after 8 weeks of using this on-line Pilates module, and will follow up 6 months later, and compare to an 8-week wait-list control group.
Detailed description
The intervention is provided through an on-line Pilates module commercially available at https://jeanniedibon.com/strengthen-your-hypermobile-core/. "Strengthen Your Hypermobile Core" has 5 modules. Subjects will be asked to complete the modules in order, as the modules build upon one another. However, subjects may repeat any modules at any time, with the goal of completing all 5 modules within the 8 week period. This allows subjects the flexibility to customize their participation by using the modules they feel are most helpful. Users who typically access this Pilates course have this same flexibility so, while it adds variability to the intervention, it better reflects how the program is actually used.
Subjects will be asked to do their Pilates practice while watching the videos (not from memory) to ensure that they are performing techniques optimally. Each module lasts 25 minutes, but includes some resting activities so modules are not vigorous or fatiguing for most people. Nonetheless, subjects will be instructed to omit activities that they feel they cannot do safely. Subjects can pause a session to add more rest breaks, if needed, or stop and complete a session later. Subjects will commit to doing 3 Pilates modules per week, for a total of 75-90 minutes/week (depending on the exact length of the modules they do).
Subjects will complete questionnaires before starting the on-line Pilates modules. Completing these questionnaires on SurveyMonkey is likely to take 30-45 minutes.
The study initially aimed to include a total of 100 participants, but more than 800 signed up within the first 2 weeks, and another 200 over the following months. The design was therefore modified to have the first 300 participants start the Pilates immediately, and the remaining participants begin after an 8-week waiting period. In addition to adding a control group, the wait-list prevented us from having to turn people away from free access to the exercise program, and from our being overwhelmed by too many participants. Because subjects were not randomly assigned and the intervention could not be directly monitored, the study is a pragmatic clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study was a pragmatic clinical trial with an intervention group and a wait-list control group. The groups were assigned sequentially and not randomly: the first group of about 300 subjects was allowed to start the exercise program immediately, while the rest became the wait-list control.
| Arm | Type | Receives |
|---|---|---|
| Pilates exercise | Experimental | Other: Online Pilates exercisePilates exercise, Trying to do 25 min of Pilates 3x/week for 8 wks |
| Wait-list control | No intervention | –Waiting 8 weeks without starting Pilates |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- i. Have some form of Hypermobility Spectrum Disorders or hypermobile Ehlers-Danlos syndrome (HSD/hEDS) diagnosed by any health care provider; this would include individuals diagnosed with Joint Hypermobility Syndrome using the pre-2017 diagnostic criteria.
- Able to read the English language and understand spoken English. iii. Willing to try to do Pilates using the 25 minute on-line training videos at least 3 times per week, unless they experience some adverse event or illness that prevents them from safely participating.
Key exclusion criteria (5 listed)
- i. Medical restrictions (such as recent and healing surgery, fractures, comorbidities such as severe rheumatoid arthritis or neurological conditions, etc.) that prevent them from safely doing gentle exercise lying down on the floor, sitting, and standing.
- Inability to safely stand (with or without using upper extremity for balance) for 10 consecutive minutes.
- Recent injuries or changes in status that are not stable. This will be defined as "A significant change in your wellness due to recent injury or new symptoms in the past month that result in your wellness during the past month being very different from the past 5 months. Flare episodes that are typical for you will not prevent you from participating at this time." iv. Significantly changed treatment approach or medication within the past 3 months or be expecting to change their treatment program (including medication changes) during the study. This would make it difficult for us to know if changes are due to the Pilates class or the change in their treatment program. However, we understand that their health status may change such that they need to change their health care routine for physical and mental health.
- Currently receiving regular rehabilitation such as physical therapy, or having received physical therapy (PT) or a similar movement-based therapy (such as such as Pilates, Feldenkrais, Tai Chi, qigung, yoga) in the past 3 months. Individuals who continue to do exercises from any of these sources are not excluded, as these individuals should be stable on their current routine.
- Currently doing more than 30 minutes/week of Pilates exercise.
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 |
|---|---|---|
| Online Pilates exerciseParticipants will be asked to do their Pilates practice while watching the videos (not from memory) to ensure that they are performing techniques optimally. Each module lasts 25 minutes, but includes some resting activities so modules are not vigorous or fatiguing for most people. Nonetheless, subjects will be instructed to omit activities that they feel they cannot do safely. Participants can pause a session to add more rest breaks, if needed, or stop and complete a session later. Participants will attempt to do 3 Pilates modules per week, for a total of 75-90 minutes/week (depending on the exact length of the modules they do). | Other | Pilates exercise |
Primary outcome
Bristol Impact of Hypermobility questionnaire (BIoH)
Time frame: Enrollment, after 8 weeks of Pilates, 6 months after completed Pilates.
The BIoH is a 55 item questionnaire that asks about pain, fatigue, joint instability, function, self-efficacy and attitudes about having hypermobility. It is the only outcome measure specifically validated for hypermobility-related conditions, and it is recommended by the international Common Data Elements initiative, whose goal is to encourage Ehlers-Danlos syndrome (EDS) researchers to use consistent outcome measures. (Palmer, 2017)
3 secondary outcomes
Tampa Scale of Kinesiophobia (TSK)
Time frame: Enrollment, after 8 weeks of Pilates, 6 months after completing Pilates.
The Revised Body Awareness Rating Questionnaire (R-BARQ)
Time frame: Enrollment, after 8 weeks of Pilates, 6 months after completing Pilates.
The International Physical Activity Questionnaire Short Form
Time frame: Time Frame: Enrollment, after 8 weeks of Pilates, 6 months after completing Pilates.
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 18 Jun 2026.
- Background: PubMed 10925833Booth M. Assessment of physical activity: an international perspective. Res Q Exerc Sport. 2000 Jun;71(2 Suppl):S114-20. No abstract available.
- Background: PubMed 29096009Dragesund T, Strand LI, Grotle M. The Revised Body Awareness Rating Questionnaire: Development Into a Unidimensional Scale Using Rasch Analysis. Phys Ther. 2018 Feb 1;98(2):122-132. doi: 10.1093/ptj/pzx111.
- Background: PubMed 27567344Palmer S, Cramp F, Lewis R, Gould G, Clark EM. Development and initial validation of the Bristol Impact of Hypermobility questionnaire. Physiotherapy. 2017 Jun;103(2):186-192. doi: 10.1016/j.physio.2016.04.002. Epub 2016 May 4.
- Background: PubMed 16055269Woby SR, Roach NK, Urmston M, Watson PJ. Psychometric properties of the TSK-11: a shortened version of the Tampa Scale for Kinesiophobia. Pain. 2005 Sep;117(1-2):137-44. doi: 10.1016/j.pain.2005.05.029.
- Derived from this study: PubMed 41737369Russek LN, Di Bon J, Herbland A, Vivlamore Zion Higgins C, Jandrew TR, Adams AM, Simmonds J. An Online Pilates Program for People with Hypermobility: A Pragmatic Clinical Trial Looking at Function, Interoception, Kinesiophobia, and Physical Activity Levels. J Multidiscip Healthc. 2026 Feb 16;19:564972. doi: 10.2147/JMDH.S564972. eCollection 2026.
- Individual participant dataSharing planned: No. Hope to share data.
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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.
Leslie N. Russek principal investigator
Professor Emeritus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Pilates exercise in people with Hypermobile Ehlers-Danlos Syndrome and Hypermobile Spectrum Disorder, run by Clarkson University at 1 site in United States.
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 2 inclusion and 5 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 18 Jun 2026. 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 United States. 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?
Bristol Impact of Hypermobility questionnaire (BIoH) (time frame: Enrollment, after 8 weeks of Pilates, 6 months after completed Pilates.). 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 NCT07118865, which also lists 5 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 18 Jun 2026.