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NCT Number: NCT07464093

STABLE Pilates for Hypermobility

This study is looking at whether Pilates-based exercise can help with hypermobility-related symptoms, like pain.

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Key information

Conditions

Ehlers-Danlos Syndrome (EDS) Cardiovascular Diseases Collagen Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Ehlers-Danlos Syndrome Ehlers-Danlos syndrome type 3 Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Hypermobile EDS (hEDS) Hypermobile Spectrum Disorder Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Abnormalities Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Chestnut Hill, Massachusetts, 01467, United States

Location status: Recruiting

Location contact

Samantha M Meints

CONTACT

[email protected]

6177329014

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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, informed consent

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, 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.

Treatment and study plan

Pilates

Behavioral

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

Education

Behavioral

Educational seminars pertaining to hypermobility symptom management

Primary outcomes

  1. Intervention Feasibility

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

    Recruitment, Retention, Attendance

  2. 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."

Secondary outcomes

  1. Pain intensity

    Time frame: Baseline, week 6 and week 12

    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.

  2. Pain interference

    Time frame: Baseline, week 6 and week 12

    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.

  3. Bristol Questionnaire

    Time frame: Baseline, week 6 and week 12

    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

  4. WPI

    Time frame: Baseline, week 6 and week 12

    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.

  5. PCS

    Time frame: Baseline, week 6 and week 12

    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.

  6. MAIA-2

    Time frame: Baseline, week 6 and week 12

    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.

  7. TSK

    Time frame: Baseline, week 6 and week 12

    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.

  8. SHS

    Time frame: Baseline, week 6 and week 12

    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

  9. Overall physical and mental health

    Time frame: Baseline, week 6 and week 12

    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

  10. Heartrate Variability

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

    resting HRV

  11. Functional mobility

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

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

  12. Functional endurance

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

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

Other outcomes

  1. Pain Sensitivity

    Time frame: Baseline testing

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Stephanie Voss, PhD

CONTACT

[email protected]

6177329181

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Bernard Osher Foundation
  • National Institutes of Health (NIH)

Registry information

Official study title

Pilates for Hypermobility: A Pilot Feasibility Study

Acronym: STABLE

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Mar 11, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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