Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 3:03 AM
Study NCT ID:
NCT07464093
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-11
First Post:
2026-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
STABLE Pilates for Hypermobility
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004535', 'term': 'Ehlers-Danlos Syndrome'}, {'id': 'C536196', 'term': 'Ehlers-Danlos syndrome type 3'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D012868', 'term': 'Skin Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D003095', 'term': 'Collagen Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-05', 'studyFirstSubmitDate': '2026-03-03', 'studyFirstSubmitQcDate': '2026-03-05', 'lastUpdatePostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pain Sensitivity', 'timeFrame': 'Baseline testing', 'description': '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).'}], 'primaryOutcomes': [{'measure': 'Intervention Feasibility', 'timeFrame': 'Enrollment to end of intervention (week 6) and follow-up (week 12)', 'description': 'Recruitment, Retention, Attendance'}, {'measure': 'Acceptability', 'timeFrame': 'Enrollment to end of intervention (week 6)', 'description': '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."'}], 'secondaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': 'Baseline, week 6 and week 12', 'description': '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.'}, {'measure': 'Pain interference', 'timeFrame': 'Baseline, week 6 and week 12', 'description': '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.'}, {'measure': 'Bristol Questionnaire', 'timeFrame': 'Baseline, week 6 and week 12', 'description': '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'}, {'measure': 'WPI', 'timeFrame': 'Baseline, week 6 and week 12', 'description': '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.'}, {'measure': 'PCS', 'timeFrame': 'Baseline, week 6 and week 12', 'description': '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.'}, {'measure': 'MAIA-2', 'timeFrame': 'Baseline, week 6 and week 12', 'description': '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.'}, {'measure': 'TSK', 'timeFrame': 'Baseline, week 6 and week 12', 'description': '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.'}, {'measure': 'SHS', 'timeFrame': 'Baseline, week 6 and week 12', 'description': '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'}, {'measure': 'Overall physical and mental health', 'timeFrame': 'Baseline, week 6 and week 12', 'description': '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'}, {'measure': 'Heartrate Variability', 'timeFrame': 'Enrollment to end of intervention (week 6) and follow-up (week 12)', 'description': 'resting HRV'}, {'measure': 'Functional mobility', 'timeFrame': 'Enrollment to end of intervention (week 6) and follow-up (week 12)', 'description': 'Functional mobility will be assessed using the Timed Up and Go (TUG) test'}, {'measure': 'Functional endurance', 'timeFrame': 'Enrollment to end of intervention (week 6) and follow-up (week 12)', 'description': 'Functional endurance will be measured with the 2-minute walk test (2MWT)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hypermobility', 'pilates', 'pain'], 'conditions': ['Ehlers-Danlos Syndrome (EDS)', 'Hypermobile EDS (hEDS)', 'Hypermobile Spectrum Disorder']}, 'descriptionModule': {'briefSummary': 'This study is looking at whether Pilates-based exercise can help with hypermobility-related symptoms, like pain.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 18 years old;\n* Self-reported hypermobility with confirmed or suspected diagnosis of hEDS/HSD;\n* Self-reported persistent pain ≥ 3 months;\n* A minimum of 3/10 self-reported pain intensity in the past week\n* Able to get on and off the floor without assistance;\n* Able to communicate fluently in English; and\n* Able to provide written, informed consent\n\nExclusion Criteria:\n\n* 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;\n* Recent surgery or acute bone, joint or nerve injury (\\<6 months);\n* Have a history of a severe or progressive neurological or movement disorder;\n* Pregnant, planning to become pregnant during the study, or currently breast feeding;\n* Unable to get on and off the floor without assistance;\n* Unable to complete study procedures due to cognitive impairment;\n* Unable to provide written, informed consent; or\n* Currently participating in or planning to participate in another physical activity, mind-body or pain-related intervention research study in the next 4 months.'}, 'identificationModule': {'nctId': 'NCT07464093', 'acronym': 'STABLE', 'briefTitle': 'STABLE Pilates for Hypermobility', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Pilates for Hypermobility: A Pilot Feasibility Study', 'orgStudyIdInfo': {'id': '2026P000203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pilates', 'description': '6 weeks of once weekly in-person Pilates-based exercise classes', 'interventionNames': ['Behavioral: Pilates']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enhanced Usual Care', 'description': '6 weeks of once weekly educational seminars pertaining to hypermobility symptom management', 'interventionNames': ['Behavioral: Education']}], 'interventions': [{'name': 'Pilates', 'type': 'BEHAVIORAL', 'description': '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', 'armGroupLabels': ['Pilates']}, {'name': 'Education', 'type': 'BEHAVIORAL', 'description': 'Educational seminars pertaining to hypermobility symptom management', 'armGroupLabels': ['Enhanced Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01467', 'city': 'Chestnut Hill', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.33065, 'lon': -71.16616}}], 'centralContacts': [{'name': 'Stephanie Voss, PhD', 'role': 'CONTACT', 'email': 'svoss2@bwh.harvard.edu', 'phone': '6177329181'}], 'overallOfficials': [{'name': 'Samantha Meints, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Bernard Osher Foundation', 'class': 'UNKNOWN'}, {'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Samantha Meints', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}