Ehlers-Danlos Syndrome (EDS), Hypermobile EDS (hEDS), Hypermobile Spectrum Disorder
Conditions
Keywords
hypermobility, pilates, pain
Brief summary
This study is looking at whether Pilates-based exercise can help with hypermobility-related symptoms, like pain.
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.
Interventions
BEHAVIORALPilates
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
BEHAVIORALEducation
Educational seminars pertaining to hypermobility symptom management
Sponsors
Brigham and Women's Hospital
Bernard Osher Foundation
National Institutes of Health (NIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Feasibility | Enrollment to end of intervention (week 6) and follow-up (week 12) | Recruitment, Retention, Attendance |
| Acceptability | 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
| Measure | Time frame | Description |
|---|---|---|
| Functional mobility | 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 |
| Functional endurance | Enrollment to end of intervention (week 6) and follow-up (week 12) | Functional endurance will be measured with the 2-minute walk test (2MWT) |
| Pain intensity | 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. |
| Pain interference | 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. |
| Bristol Questionnaire | 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 |
| WPI | 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. |
| PCS | 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. |
| MAIA-2 | 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. |
| TSK | 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. |
| Overall physical and mental health | 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 |
| SHS | 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 |
| Heartrate Variability | Enrollment to end of intervention (week 6) and follow-up (week 12) | resting HRV |
Countries
United States
Contacts
CONTACTStephanie Voss, PhD
PRINCIPAL_INVESTIGATORSamantha Meints, PhD
Brigham and Women's Hospital
Outcome results
None listed