Inspiratory Muscle Training for Ehlers-Danlos Syndrome

Overseen By Dmitry Rozenberg, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Other EDS, Cardiac disease, Lung disease, Neuromuscular disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 8 weeks

34 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Individuals with hypermobile Ehlers-Danlos Syndrome (hEDS) and Hypermobility Spectrum Disorders (HSD) often experience dyspnea. Inspiratory Muscle Training (IMT) has been shown to improve dyspnea and respiratory muscle function; however, the impact of IMT in combination with whole-body exercise training on respiratory muscle strength, dyspnea, and daily function remains unknown. The objectives of this research are i) to evaluate dyspnea, respiratory muscle strength and function, ventilatory parameters, and health-related quality of life (HRQL) in individuals with hEDS and HSD compared to healthy age and sex-matched controls, ii) to explore the contributors to dyspnea during exercise with a specific focus on respiratory muscle structure and function in hEDS and HSD patients and healthy controls, and iii) to assess whether the combination of IMT and whole-body exercise training will be more effective than whole-body exercise training alone in improving participant outcomes in hEDS and HSD participants. It is hypothesized that i) hEDS and HSD participants will have lower respiratory muscle strength, higher peripheral airway resistance, lower HRQL, and higher anxiety and depression levels compared to healthy controls, ii) the contributors to increased exercise induced dyspnea will include decreased respiratory muscle strength, increased airway resistance, and greater prefrontal cortical neural activity, and iii) the combination of IMT and whole-body exercise training will be superior to whole-body training alone for improving dyspnea, respiratory muscle strength and endurance, aerobic capacity, HRQL, anxiety, and depression.

Who Is on the Research Team?

Dmitry Rozenberg, MD, PhD

Principal Investigator

University Health Network/University of Toronto

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You have been diagnosed with hypermobile Ehlers-Danlos syndrome (hEDS) or hypermobility spectrum disorder (HSD) by a medical team that specializes in these conditions.

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 have recently been referred to the GoodHope Exercise and Rehabilitation (GEAR) Program at the University Health Network.

Exclusion 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline evaluations of dyspnea, pulmonary function tests, respiratory muscle structure and function, HRQL, anxiety, and depression

1 week

1 visit (in-person)

Treatment

Participants undergo 8 weeks of whole-body exercises with or without Inspiratory Muscle Training (IMT)

8 weeks

4 visits (in-person), weekly virtual supervision

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Usual Care plus Inspiratory Muscle Training (IMT)

Trial Overview 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.

How Is the Trial Designed?

Group I: Usual Care plus Inspiratory Muscle Training (IMT) Experimental Treatment 1 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 Care Active Control 1 Intervention

Participants will participate in the standard of care rehabilitation program offered to hEDS and HSD patients at the University Health Network.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+