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Inspiratory Muscle Training for Ehlers-Danlos Syndrome
N/A
Recruiting
Led By Dmitry Rozenberg, MD, PhD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 days
Treatment Varies
Follow Up 3 days
Awards & highlights
Study Summary
This trial is studying whether a combination of inspiratory muscle training and whole-body exercise training is more effective than whole-body exercise training alone in improving dyspnea, respiratory muscle strength and endurance, aerobic capacity, HRQL, anxiety, and depression in individuals with hEDS and HSD.
Who is the study for?
Adults diagnosed with hypermobile Ehlers-Danlos Syndrome (hEDS) or Hypermobility Spectrum Disorders (HSD), who are new referrals to the GEAR Program. Participants must meet specific diagnostic criteria and can't have conditions like unstable heart disease, recent respiratory infections, other types of EDS, neuromuscular diseases, severe autonomic dysfunction, or be pregnant.Check my eligibility
What is being tested?
The trial is testing if Inspiratory Muscle Training (IMT) combined with whole-body exercise improves breathing difficulties, muscle strength in the lungs, quality of life and mental health for those with hEDS/HSD compared to just exercise alone.See study design
What are the potential side effects?
Potential side effects from IMT may include discomfort while breathing during training sessions and chest pain. However, individuals with a history of certain medical conditions that could worsen these symptoms are excluded from the trial.
Timeline
Screening ~ 3 days1 visit
Treatment ~ Varies
Follow Up ~ 3 days1 visit
Screening ~ 3 days
Treatment ~ Varies
Follow Up ~3 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximal Inspiratory Pressure
Secondary outcome measures
Adherence to Inspiratory Muscle Training Days
Adherence to Inspiratory Muscle Training Load
Adverse Events During Inspiratory Muscle Training Practice (Safety and Tolerability)
+28 moreOther outcome measures
Body Mass Index
Diagnostic radiologic examination
Demographic Data
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Usual Care plus Inspiratory Muscle Training (IMT)Experimental Treatment1 Intervention
Participants will attend the standard of care rehabilitation program offered to hEDS and HSD patients at the University Health Network. The program consists of i) an individualized home-based rehabilitation and exercise program (twelve weeks of aerobic, neuromotor, and resistance-based exercises), ii) a self-management education intervention, and iii) a community resource engagement plan. Furthermore, patients attend four on-site sessions (a baseline assessment and three follow-up visits).
Participants in this group will also be provided with a personalized prescription for an IMT program for eight weeks to be performed in the home environment (two daily IMT sessions of 30 breaths, five days per week). Participants will be virtually supervised by the study team weekly with any adverse events closely monitored. Participants will receive instructions and feedback on how to optimize their home training efforts with direct observation of their IMT practice.
Group II: Usual CareActive Control1 Intervention
Participants will participate in the standard of care rehabilitation program offered to hEDS and HSD patients at the University Health Network.
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,475 Previous Clinical Trials
485,056 Total Patients Enrolled
4 Trials studying Ehlers-Danlos Syndrome
364 Patients Enrolled for Ehlers-Danlos Syndrome
Dmitry Rozenberg, MD, PhDPrincipal InvestigatorUniversity Health Network/University of Toronto
1 Previous Clinical Trials
50 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a muscle condition that could affect my breathing therapy.My genetic test confirmed I have a specific type of EDS.You are not able to do exercise testing due to unstable heart disease, or you have a pacemaker or implantable defibrillator, or certain heart abnormalities found on an echocardiogram.I have ongoing symptoms or trouble with my breathing treatment.You have been diagnosed with hypermobile Ehlers-Danlos syndrome (hEDS) or hypermobility spectrum disorder (HSD) by a medical team that specializes in these conditions.I have had a lung infection or been diagnosed with a lung condition like asthma or COPD in the last month.I have had a collapsed lung, ear infections, or eardrum ruptures.You have participated in a formal exercise program or IMT program in the last 3 months.I have severe issues with my body's automatic functions or a condition that causes rapid heartbeat when standing, limiting my daily activities.I am 18 years old or older.You have been diagnosed with hypermobile Ehlers-Danlos syndrome (hEDS) based on specific criteria or with hypermobility spectrum disorder (HSD) confirmed by a medical team specializing in Ehlers-Danlos syndrome.You are pregnant according to your own report.You have recently been referred to the GoodHope Exercise and Rehabilitation (GEAR) Program at the University Health Network.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Care plus Inspiratory Muscle Training (IMT)
- Group 2: Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 3 null
- Follow Ups: You may be asked to continue sharing information regarding the trial for 3 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this research experiment currently taking place?
"Clinicaltrials.gov attests that this trial is open to participants, having been posted on August 16th 2021 and recently edited on November 3rd 2022."
Answered by AI
How many individuals are enrolled in this research endeavor?
"Affirmative. Per the clinicaltrials.gov website, this trial is presently enrolling individuals. The original posting was made on August 16th 2021 and its most recent edit was November 3rd 2022. This study requires 34 participants from 1 particular centre to participate in it."
Answered by AI
Who else is applying?
What state do they live in?
Pennsylvania
What site did they apply to?
University Health Network
What portion of applicants met pre-screening criteria?
Met criteria
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