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RecruitingNCT07464093STABLEUpdated Aug 19, 2026

STABLE Pilates for Hypermobility

An interventional study of Pilates and Education in Ehlers-Danlos Syndrome (EDS), Hypermobile EDS (hEDS) and Hypermobile Spectrum Disorder, sponsored by Brigham and Women's Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.

Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2026; still recruiting 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

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Conditions studied

  • Ehlers-Danlos Syndrome (EDS)
  • Hypermobile EDS (hEDS)
  • Hypermobile Spectrum Disorder

Keywords

  • hypermobility
  • pilates
  • pain
03

In context

Ehlers-Danlos Syndrome

66 studies on the registry are indexed under Ehlers-Danlos Syndrome; 24 are open to participants now.

This study's planned enrollment of 100 is above the median of 60 across 32 interventional studies indexed under Ehlers-Danlos Syndrome.

Browse Ehlers-Danlos Syndrome studies →

Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,267 studies on the registry; 228 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • ≥ 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,

Exclusion criteria

Exclusion Criteria:

  • 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, ; 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Pilates

    6 weeks of once weekly in-person Pilates-based exercise classes

    Behavioral: Pilates

  • Active comparator
    Enhanced Usual Care

    6 weeks of once weekly educational seminars pertaining to hypermobility symptom management

    Behavioral: Education

Interventions

  • BehavioralPilates

    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

  • BehavioralEducation

    Educational seminars pertaining to hypermobility symptom management

06

What researchers measure

Primary outcomes

  1. Intervention Feasibility

    Recruitment, Retention, Attendance

    Time frame: Enrollment to end of intervention (week 6) and follow-up (week 12)

  2. 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."

    Time frame: Enrollment to end of intervention (week 6)

Secondary outcomes

  1. 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.

    Time frame: Baseline, week 6 and week 12

  2. 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.

    Time frame: Baseline, week 6 and week 12

  3. 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

    Time frame: Baseline, week 6 and week 12

  4. 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.

    Time frame: Baseline, week 6 and week 12

  5. 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.

    Time frame: Baseline, week 6 and week 12

  6. 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.

    Time frame: Baseline, week 6 and week 12

  7. 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.

    Time frame: Baseline, week 6 and week 12

  8. 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

    Time frame: Baseline, week 6 and week 12

  9. 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

    Time frame: Baseline, week 6 and week 12

  10. Heartrate Variability

    resting HRV

    Time frame: Enrollment to end of intervention (week 6) and follow-up (week 12)

  11. Functional mobility

    Functional mobility will be assessed using the Timed Up and Go (TUG) test

    Time frame: Enrollment to end of intervention (week 6) and follow-up (week 12)

  12. Functional endurance

    Functional endurance will be measured with the 2-minute walk test (2MWT)

    Time frame: Enrollment to end of intervention (week 6) and follow-up (week 12)

Other outcomes

  1. Pain Sensitivity

    Pain sensitivity will be assessed using a Quantitative Sensory Testing (QST) battery. The QST assessment will include responses to innocuous stimuli, mechanical pain sensitivity, heat sensitivity, conditioned pain modulation, and temporal summation of pain (a measure of central sensitizability).

    Time frame: Baseline testing

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07464093
Collaborators
Bernard Osher Foundation, National Institutes of Health (NIH)
Responsible party
Samantha Meints (Assistant Professor, Brigham and Women's Hospital) — Principal investigator
First posted
Mar 11, 2026
Start date
Jul 9, 2026
Primary completion
Dec 2026 (estimated)
Completion
Dec 2027 (estimated)
Last update
Aug 19, 2026

Study contacts

Stephanie Voss, PhD
Contact
svoss2@bwh.harvard.edu
6177329181
Samantha Meints, PhD
principal investigator · Brigham and Women's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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