Ehlers-Danlos Syndrome (EDS)STABLENCT07464093
STABLE Pilates for Hypermobility
A study testing Pilates and Education in people with Ehlers-Danlos Syndrome (EDS) and Hypermobile EDS (hEDS), run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This study is looking at whether Pilates-based exercise can help with hypermobility-related symptoms, like pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ehlers-Danlos Syndrome (EDS), Hypermobile EDS (hEDS), Hypermobile Spectrum Disorder
- What is being tested?
- Pilates and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years old;
- Self-reported hypermobility with confirmed or suspected diagnosis of hEDS/HSD;
- Self-reported persistent pain ≥ 3 months;
- A minimum of 3/10 self-reported pain intensity in the past week
- Able to get on and off the floor without assistance;
- Able to communicate fluently in English; and
- Able to provide written, informed consent
Who cannot join
- Regular ongoing mind-body practice (e.g. Tai chi, yoga, pilates) defined as a regular weekly practice of at least 20min/week over the past 6 months;
- Recent surgery or acute bone, joint or nerve injury (<6 months);
- Have a history of a severe or progressive neurological or movement disorder;
- Pregnant, planning to become pregnant during the study, or currently breast feeding;
- Unable to get on and off the floor without assistance;
- Unable to complete study procedures due to cognitive impairment;
- Unable to provide written, informed consent; or
- Currently participating in or planning to participate in another physical activity, mind-body or pain-related intervention research study in the next 4 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, 01467
Samantha M Meints, 6177329014, smeints@bwh.harvard.edu
About this study
Official title: Pilates for Hypermobility: A Pilot Feasibility Study
This study is looking at whether Pilates-based exercise can help with hypermobility-related symptoms, like pain.
Read the detailed description
In this study, investigators are looking at whether 6 weeks of Pilates-based exercise led by a licensed physical therapist can help with hypermobility-related symptoms, like pain. Pilates is a gentle mind-body exercise with an emphasis on muscular control, postural awareness, and breathing that may be particularly well-suited for managing hypermobility. Exercises are mostly floor-based and focus on developing muscular strength and stability which may improve pain and symptom management.
- Being tested
- Pilates, Education
- Keywords
- hypermobility, pilates, pain
- Medical subject headings
- Ehlers-Danlos Syndrome, Ehlers-Danlos syndrome type 3, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PilatesBehavioural
Pilates is a gentle mind-body exercise with an emphasis on muscular control, postural awareness, and breathing that may be particularly well-suited for managing hypermobility. Exercises are mostly floor-based and focus on developing muscular strength and stability which may improve pain and symptom management
EducationBehavioural
Educational seminars pertaining to hypermobility symptom management
| Study group | Role | What they receive |
|---|---|---|
| Pilates | Experimental | 6 weeks of once weekly in-person Pilates-based exercise classes Receives: Behavioral: Pilates |
| Enhanced Usual Care | Active comparator | 6 weeks of once weekly educational seminars pertaining to hypermobility symptom management Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Feasibility
Recruitment, Retention, Attendance
Measured: Enrollment to end of intervention (week 6) and follow-up (week 12)
Acceptability
Treatment Helpfulness Questionnaire (THQ): The THQ is a single-item measure that evaluates the perception of helpfulness of an intervention. Participants will be asked to rate the helpfulness of the intervention to which they are randomized on a scale of -5 (extremely harmful) to 5 (extremely helpful) with 0 indicating "neutral."
Measured: Enrollment to end of intervention (week 6)
Secondary outcomes (12)
Pain intensity
The Patient Reported Outcomes Measurement Information System Profile (PROMIS-29) will be used to assess pain intensity. Scores range from 8-40 with higher scores indicating a greater presence of the corresponding construct.
Measured: Baseline, week 6 and week 12
Pain interference
The Patient Reported Outcomes Measurement Information System Profile (PROMIS-29) will be used to assess pain interference. Scores range from 8-40 with higher scores indicating a greater presence of the corresponding construct.
Measured: Baseline, week 6 and week 12
Bristol Questionnaire
The Bristol Impact of Hypermobility Questionnaire will be used to assess the self-reported functional impact of joint hypermobility. Higher scores indicate more severe functional impact
Measured: Baseline, week 6 and week 12
WPI
The Widespread Pain Inventory (WPI) will be used to assess the widespreadness of body pain. Scores range from 0-19 with higher scores indicating more widespread pain.
Measured: Baseline, week 6 and week 12
PCS
The Pain Catastrophizing Scale (PCS) will be used to assess pain-related rumination, magnification, and helplessness in response to pain. Scores range from 0-52 with higher scores indicating more pain catastrophizing.
Measured: Baseline, week 6 and week 12
MAIA-2
The Multidimensional Assessment of Interoceptive Awareness-2 (MAIA-2) will be used to assess 8 domains pertaining to beliefs about the body and tendencies to be internally focused, including noticing, not distracting, not worrying, attention regulation, emotional awareness, body listening and trusting. Scores range from 0-5 with higher scores indicating higher interoceptive sensibility.
Measured: Baseline, week 6 and week 12
TSK
The Tampa Scale of Kinesiophobia (TSK) will be used to assess fear of movement. Scores range from 17-68 with higher scores indicating more fear of movement.
Measured: Baseline, week 6 and week 12
SHS
The Sensory Hypersensitivity Scale (SHS) will be used to assess multisensory sensitivity to items related to sensitivity to light, heat, cold, allergies, pain, smell, hearing, taste, and touch. Higher scores indicate more multisensory sensitivity. The scale will be modified to include an additional rating of bothersomeness from 1 (Not bothersome at all) to 5 (Extremely bothersome) for each of the original scale items to evaluate multisensory bothersomeness
Measured: Baseline, week 6 and week 12
Overall physical and mental health
The Patient Reported Outcomes Measurement Information System Profile (PROMIS-29) will be used to assess overall physical and mental health, with subscales including physical function, anxiety, depression, fatigue, social participation, and sleep disturbance. Scores range from 8-40 with higher scores indicating a greater degree of the corresponding construct
Measured: Baseline, week 6 and week 12
Heartrate Variability
resting HRV
Measured: Enrollment to end of intervention (week 6) and follow-up (week 12)
Functional mobility
Functional mobility will be assessed using the Timed Up and Go (TUG) test
Measured: Enrollment to end of intervention (week 6) and follow-up (week 12)
Functional endurance
Functional endurance will be measured with the 2-minute walk test (2MWT)
Measured: Enrollment to end of intervention (week 6) and follow-up (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start9 Jul 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ehlers-Danlos Syndrome (EDS)Studies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bernard Osher Foundation, National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Samantha Meints, Brigham and Women's Hospital
- Investigators
- Samantha Meints, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07464093
- Sponsor's protocol ID
- 2026P000203
- Acronym
- STABLE
- Status last verified
- Aug 2026
- First submitted
- 3 Mar 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilates for Hypermobility: A Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT07464093
- Acronym / sponsor ID
- STABLE / 2026P000203
- Keywords
- hypermobility, pilates, pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Bernard Osher Foundation, National Institutes of Health (NIH)
- Study start
- 9 Jul 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 11 Mar 2026 (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.
This study is looking at whether Pilates-based exercise can help with hypermobility-related symptoms, like pain.
Detailed description
In this study, investigators are looking at whether 6 weeks of Pilates-based exercise led by a licensed physical therapist can help with hypermobility-related symptoms, like pain. Pilates is a gentle mind-body exercise with an emphasis on muscular control, postural awareness, and breathing that may be particularly well-suited for managing hypermobility. Exercises are mostly floor-based and focus on developing muscular strength and stability which may improve pain and symptom management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilates | Experimental | Behavioral: Pilates6 weeks of once weekly in-person Pilates-based exercise classes |
| Enhanced Usual Care | Active comparator | Behavioral: Education6 weeks of once weekly educational seminars pertaining to hypermobility symptom management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥ 18 years old;
- Self-reported hypermobility with confirmed or suspected diagnosis of hEDS/HSD;
- Self-reported persistent pain ≥ 3 months;
- A minimum of 3/10 self-reported pain intensity in the past week
- Able to get on and off the floor without assistance;
Key exclusion criteria (8 listed)
- Regular ongoing mind-body practice (e.g. Tai chi, yoga, pilates) defined as a regular weekly practice of at least 20min/week over the past 6 months;
- Recent surgery or acute bone, joint or nerve injury (<6 months);
- Have a history of a severe or progressive neurological or movement disorder;
- Pregnant, planning to become pregnant during the study, or currently breast feeding;
- Unable to get on and off the floor without assistance;
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 |
|---|---|---|
| PilatesPilates is a gentle mind-body exercise with an emphasis on muscular control, postural awareness, and breathing that may be particularly well-suited for managing hypermobility. Exercises are mostly floor-based and focus on developing muscular strength and stability which may improve pain and symptom management | Behavioural | Pilates |
| EducationEducational seminars pertaining to hypermobility symptom management | Behavioural | Enhanced Usual Care |
Primary outcome
Intervention Feasibility
Time frame: Enrollment to end of intervention (week 6) and follow-up (week 12)
Recruitment, Retention, Attendance
Acceptability
Time frame: Enrollment to end of intervention (week 6)
Treatment Helpfulness Questionnaire (THQ): The THQ is a single-item measure that evaluates the perception of helpfulness of an intervention. Participants will be asked to rate the helpfulness of the intervention to which they are randomized on a scale of -5 (extremely harmful) to 5 (extremely helpful) with 0 indicating "neutral."
12 secondary outcomes
Pain intensity
Time frame: Baseline, week 6 and week 12
Pain interference
Time frame: Baseline, week 6 and week 12
Bristol Questionnaire
Time frame: Baseline, week 6 and week 12
WPI
Time frame: Baseline, week 6 and week 12
PCS
Time frame: Baseline, week 6 and week 12
MAIA-2
Time frame: Baseline, week 6 and week 12
TSK
Time frame: Baseline, week 6 and week 12
SHS
Time frame: Baseline, week 6 and week 12
Overall physical and mental health
Time frame: Baseline, week 6 and week 12
Heartrate Variability
Time frame: Enrollment to end of intervention (week 6) and follow-up (week 12)
Functional mobility
Time frame: Enrollment to end of intervention (week 6) and follow-up (week 12)
Functional endurance
Time frame: Enrollment to end of intervention (week 6) and follow-up (week 12)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Ehlers-Danlos Syndrome (EDS)
Enrolling by invitationObservational study
Presentation of Young Adults With and Without Joint Hypermobility
Hypermobile Ehlers-Danlos Syndrome, Postural Orthostatic Tachycardia Syndrome (POTS)
Active, not recruitingObservational study
Local Anesthetic Response in Ehlers-Danlos Syndrome (EDS) and Healthy Volunteers
Ehlers-Danlos Syndrome, Anesthesia, Local
Not yet recruitingPhase 1/2
Regenerative Medicine for Joint Hypermobility and Instability
Ehlers-Danlos Syndrome Hypermobility Type (hEDS), Ehlers-Danlos Syndrome (EDS)
Not yet recruiting
COG+OT Telerehabilitation for Adults With Subjective Cognitive Complaints
Subjective Cognitive Complaints, Ehlers-Danlos Syndrome
RecruitingObservational study
PregnAncy-Related Aortic DISsEction in China
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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.
Samantha Meints, PhD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates and Education in people with Ehlers-Danlos Syndrome (EDS) and Hypermobile EDS (hEDS), run by Brigham and Women's Hospital 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 7 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 19 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Voss, PhD (6177329181, svoss2@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Feasibility (time frame: Enrollment to end of intervention (week 6) and follow-up (week 12)). The study lists 2 primary outcomes in all. 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 19 Aug 2026.