NCT07464093

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
17mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 11, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

June 11, 2026

Status Verified

June 1, 2026

Enrollment Period

5 months

First QC Date

March 3, 2026

Last Update Submit

June 9, 2026

Conditions

Keywords

hypermobilitypilatespain

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (12)

  • Pain intensity

    Baseline, week 6 and week 12

  • Pain interference

    Baseline, week 6 and week 12

  • Bristol Questionnaire

    Baseline, week 6 and week 12

  • WPI

    Baseline, week 6 and week 12

  • PCS

    Baseline, week 6 and week 12

  • +7 more secondary outcomes

Other Outcomes (1)

  • Pain Sensitivity

    Baseline testing

Study Arms (2)

Pilates

EXPERIMENTAL

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

Behavioral: Pilates

Enhanced Usual Care

ACTIVE COMPARATOR

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

Behavioral: Education

Interventions

PilatesBEHAVIORAL

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

Pilates
EducationBEHAVIORAL

Educational seminars pertaining to hypermobility symptom management

Enhanced Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Chestnut Hill, Massachusetts, 01467, United States

RECRUITING

MeSH Terms

Conditions

Ehlers-Danlos SyndromeEhlers-Danlos syndrome type 3Pain

Interventions

Exercise Movement TechniquesEducational Status

Condition Hierarchy (Ancestors)

Hemostatic DisordersVascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic DiseasesSkin AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticGenetic Diseases, InbornCollagen DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeuticsSocioeconomic FactorsPopulation Characteristics

Study Officials

  • Samantha Meints, PhD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Voss, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 3, 2026

First Posted

March 11, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

June 11, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations