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
This study is looking at whether Pilates-based exercise can help with hypermobility-related symptoms, like pain.
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.
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 →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.
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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.
Exclusion Criteria:
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
6 weeks of once weekly in-person Pilates-based exercise classes
Behavioral: Pilates
6 weeks of once weekly educational seminars pertaining to hypermobility symptom management
Behavioral: Education
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
Educational seminars pertaining to hypermobility symptom management
Intervention Feasibility
Recruitment, Retention, Attendance
Time frame: 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."
Time frame: Enrollment to end of intervention (week 6)
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
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
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
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
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
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
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
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
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
Heartrate Variability
resting HRV
Time frame: 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
Time frame: 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)
Time frame: Enrollment to end of intervention (week 6) and follow-up (week 12)
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
Plan to share: No
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