Online Pilates Exercise for People With Hypermobility

NCT07118865 | Completed

• 1 other identifier: 19-48.3
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

Brief Summary

People with hypermobile Ehlers-Danlos Syndrome/Hypermobility Spectrum Disorder (hEDS/HSD) often have pain, coordination problems, and low tolerance to activity and exercise. There is a publicly available on-line, independent Pilates program designed specifically for this population. This research project proposes to measure pain, function, and common symptoms in individuals before and after 8 weeks of using this on-line Pilates module, and will follow up 6 months later, and compare to an 8-week wait-list control group.

Conditions

Hypermobile Ehlers-Danlos Syndrome; Hypermobile Spectrum Disorder

Keywords

hypermobile Ehlers-Danlos Syndrome, Pilates, Exercise

Outcome Measures

Primary Outcomes (1)

• Bristol Impact of Hypermobility questionnaire (BIoH)

  The BIoH is a 55 item questionnaire that asks about pain, fatigue, joint instability, function, self-efficacy and attitudes about having hypermobility. It is the only outcome measure specifically validated for hypermobility-related conditions, and it is recommended by the international Common Data Elements initiative, whose goal is to encourage Ehlers-Danlos syndrome (EDS) researchers to use consistent outcome measures. (Palmer, 2017)

  Enrollment, after 8 weeks of Pilates, 6 months after completed Pilates.

Secondary Outcomes (3)

• Tampa Scale of Kinesiophobia (TSK)

  Enrollment, after 8 weeks of Pilates, 6 months after completing Pilates.

• The Revised Body Awareness Rating Questionnaire (R-BARQ)

  Enrollment, after 8 weeks of Pilates, 6 months after completing Pilates.

• The International Physical Activity Questionnaire Short Form

  Time Frame: Enrollment, after 8 weeks of Pilates, 6 months after completing Pilates.

Other Outcomes (1)

• Adverse events

  After 8 weeks of Pilates

Study Arms (2)

Pilates exercise

EXPERIMENTAL

Pilates exercise, Trying to do 25 min of Pilates 3x/week for 8 wks

Other: Online Pilates exercise

Wait-list control

NO INTERVENTION

Waiting 8 weeks without starting Pilates

Interventions

Online Pilates exercise OTHER

Participants will be asked to do their Pilates practice while watching the videos (not from memory) to ensure that they are performing techniques optimally. Each module lasts 25 minutes, but includes some resting activities so modules are not vigorous or fatiguing for most people. Nonetheless, subjects will be instructed to omit activities that they feel they cannot do safely. Participants can pause a session to add more rest breaks, if needed, or stop and complete a session later. Participants will attempt to do 3 Pilates modules per week, for a total of 75-90 minutes/week (depending on the exact length of the modules they do).

Pilates exercise

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• i. Have some form of Hypermobility Spectrum Disorders or hypermobile Ehlers-Danlos syndrome (HSD/hEDS) diagnosed by any health care provider; this would include individuals diagnosed with Joint Hypermobility Syndrome using the pre-2017 diagnostic criteria.
• ii. Able to read the English language and understand spoken English. iii. Willing to try to do Pilates using the 25 minute on-line training videos at least 3 times per week, unless they experience some adverse event or illness that prevents them from safely participating.

You may not qualify if:

• i. Medical restrictions (such as recent and healing surgery, fractures, comorbidities such as severe rheumatoid arthritis or neurological conditions, etc.) that prevent them from safely doing gentle exercise lying down on the floor, sitting, and standing.
• ii. Inability to safely stand (with or without using upper extremity for balance) for 10 consecutive minutes.
• iii. Recent injuries or changes in status that are not stable. This will be defined as "A significant change in your wellness due to recent injury or new symptoms in the past month that result in your wellness during the past month being very different from the past 5 months. Flare episodes that are typical for you will not prevent you from participating at this time." iv. Significantly changed treatment approach or medication within the past 3 months or be expecting to change their treatment program (including medication changes) during the study. This would make it difficult for us to know if changes are due to the Pilates class or the change in their treatment program. However, we understand that their health status may change such that they need to change their health care routine for physical and mental health.
• v. Currently receiving regular rehabilitation such as physical therapy, or having received physical therapy (PT) or a similar movement-based therapy (such as such as Pilates, Feldenkrais, Tai Chi, qigung, yoga) in the past 3 months. Individuals who continue to do exercises from any of these sources are not excluded, as these individuals should be stable on their current routine.
• vi. Currently doing more than 30 minutes/week of Pilates exercise.

Sponsors & Collaborators

• Clarkson University: lead

Study Sites (1)

Clarkson University. Entire study is online, no physical site used.

Potsdam, New York, 13699, United States

Location

Related Publications (4)

• Booth M. Assessment of physical activity: an international perspective. Res Q Exerc Sport. 2000 Jun;71(2 Suppl):S114-20. No abstract available.

  PMID: 10925833 BACKGROUND

• Dragesund T, Strand LI, Grotle M. The Revised Body Awareness Rating Questionnaire: Development Into a Unidimensional Scale Using Rasch Analysis. Phys Ther. 2018 Feb 1;98(2):122-132. doi: 10.1093/ptj/pzx111.

  PMID: 29096009 BACKGROUND

• Palmer S, Cramp F, Lewis R, Gould G, Clark EM. Development and initial validation of the Bristol Impact of Hypermobility questionnaire. Physiotherapy. 2017 Jun;103(2):186-192. doi: 10.1016/j.physio.2016.04.002. Epub 2016 May 4.

  PMID: 27567344 BACKGROUND

• Woby SR, Roach NK, Urmston M, Watson PJ. Psychometric properties of the TSK-11: a shortened version of the Tampa Scale for Kinesiophobia. Pain. 2005 Sep;117(1-2):137-44. doi: 10.1016/j.pain.2005.05.029.

  PMID: 16055269 BACKGROUND

MeSH Terms

Conditions

Ehlers-Danlos syndrome type 3; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Leslie N. Russek

  Professor Emeritus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Masking is not practical for an exercise intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Emeritus of Physical Therapy

Model Details: The study was a pragmatic clinical trial with an intervention group and a wait-list control group. The groups were assigned sequentially and not randomly: the first group of about 300 subjects was allowed to start the exercise program immediately, while the rest became the wait-list control.

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 12, 2025
• Study Start: September 15, 2019
• Primary Completion: March 21, 2021
• Study Completion: March 21, 2021
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)