Usual Care plus Inspiratory Muscle Training (IMT) for Hypermobile Ehlers-Danlos Syndrome (hEDS)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Hypermobile Ehlers-Danlos Syndrome (hEDS)+1 MoreUsual Care plus Inspiratory Muscle Training (IMT) - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Joint Hypermobility Syndrome
  • Hypermobile Ehlers-Danlos Syndrome (hEDS)

Treatment Effectiveness

Study Objectives

1 Primary · 32 Secondary · Reporting Duration: Baseline

Baseline
Diagnostic radiologic examination
Demographic Data
Electrocardiogram
Leisure-Time Exercise
Week 8
Body Mass Index
Physical Activity Levels
Dyspnea
Respiratory Muscle Endurance
Waist Circumference
Week 8
Anxiety and Depression
Borg Dyspnea Scale
Depression, Anxiety and Stress Scale
Diaphragm Thickening Fraction
Diaphragm Thickness
Health-Related Quality of Life
Heart Rate Response During Cardiopulmonary Exercise Testing
Lung Volumes (Inspiratory Capacity)
Lung Volumes (Residual Volume)
Lung Volumes (Total Lung Capacity)
Maximal Expiratory Pressure
Maximal Inspiratory Pressure
Medical Research Council Dyspnea Scale
Oscillometry
Peak Oxygen Uptake During Cardiopulmonary Exercise Testing
Pre-frontal Cortical Neural Activity During Cardiopulmonary Exercise Testing
Spirometry (Forced Expiratory Volume in 1 Second)
Spirometry (Forced Vital Capacity)
Ventilatory Response During Cardiopulmonary Exercise Testing
Week 1
Participant Satisfaction with the IMT Intervention
Week 8
Adherence to Inspiratory Muscle Training Days
Adherence to Inspiratory Muscle Training Load
Adverse Events During Inspiratory Muscle Training Practice (Safety and Tolerability)
Week 8
Participant Retention in the Study
Participant Study Recruitment
Week 8
Inspiratory Muscle Training Load
Inspiratory Muscle Training Mean Power
Muscle Proteins
Inspiratory Muscle Training Workload

Trial Safety

Trial Design

2 Treatment Groups

Usual Care
1 of 2
Usual Care plus Inspiratory Muscle Training (IMT)
1 of 2

Active Control

Experimental Treatment

34 Total Participants · 2 Treatment Groups

Primary Treatment: Usual Care plus Inspiratory Muscle Training (IMT) · No Placebo Group · N/A

Usual Care plus Inspiratory Muscle Training (IMT)
Behavioral
Experimental Group · 1 Intervention: Usual Care plus Inspiratory Muscle Training (IMT) · Intervention Types: Behavioral
Usual CareNoIntervention Group · 1 Intervention: Usual Care · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,382 Previous Clinical Trials
473,441 Total Patients Enrolled
Dmitry Rozenberg, MD, PhDPrincipal InvestigatorUniversity Health Network/University of Toronto

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been diagnosed with HEDS based on the 2017 diagnostic criteria or diagnosis of HSD.
References