STABLE Pilates for Hypermobility (STABLE)

Pilates for Hypermobility: A Pilot Feasibility Study

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

Study Overview

• Status: Not yet recruiting
• Conditions: Hypermobile EDS (hEDS); Ehlers-Danlos Syndrome (EDS); Hypermobile Spectrum Disorder
• Intervention / Treatment: Behavioral: Pilates; Behavioral: Education

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephanie Voss, PhD; Phone Number: 6177329181; Email: svoss2@bwh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Chestnut Hill, Massachusetts, United States, 01467
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pilates; 6 weeks of once weekly in-person Pilates-based exercise classes	Behavioral: Pilates; 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
Active Comparator: Enhanced Usual Care; 6 weeks of once weekly educational seminars pertaining to hypermobility symptom management	Behavioral: Education; Educational seminars pertaining to hypermobility symptom management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention Feasibility	Recruitment, Retention, Attendance	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."	Enrollment to end of intervention (week 6)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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.	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.	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.	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.	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	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	Baseline, week 6 and week 12
Heartrate Variability	resting HRV	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	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)	Enrollment to end of intervention (week 6) and follow-up (week 12)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline testing

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: National Institutes of Health (NIH); Bernard Osher Foundation
• Investigators: Principal Investigator: Samantha Meints, PhD, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 3, 2026
• First Submitted That Met QC Criteria: March 5, 2026
• First Posted (Actual): March 11, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: pain; pilates; hypermobility
• Additional Relevant MeSH Terms: Neurologic Manifestations; Vascular Diseases; Cardiovascular Diseases; Genetic Diseases, Inborn; Connective Tissue Diseases; Hematologic Diseases; Skin Diseases; Congenital Abnormalities; Hemostatic Disorders; Hemorrhagic Disorders; Skin Diseases, Genetic; Skin Abnormalities; Collagen Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Signs and Symptoms; Hemic and Lymphatic Diseases; Pain; Ehlers-Danlos Syndrome; Ehlers-Danlos syndrome type 3; Therapeutics; Physical Therapy Modalities; Socioeconomic Factors; Population Characteristics; Educational Status; Exercise Movement Techniques
• Other Study ID Numbers: 2026P000203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No