Usual Care plus Inspiratory Muscle Training (IMT) for Hypermobile Ehlers-Danlos Syndrome (hEDS)
Phase-Based Progress Estimates
Effectiveness
Safety
Hypermobile Ehlers-Danlos Syndrome (hEDS)+1 MoreUsual Care plus Inspiratory Muscle Training (IMT) - Behavioral
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
Effectiveness Progress
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: BehavioralUsual 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
- Hakim, A. J.. 2004. “Non-musculoskeletal Symptoms in Joint Hypermobility Syndrome. Indirect Evidence for Autonomic Dysfunction?”. Rheumatology. Oxford University Press (OUP). doi:10.1093/rheumatology/keh279.
- Gazit, Yael, A.Menahem Nahir, Rodney Grahame, and Giris Jacob. 2003. “Dysautonomia in the Joint Hypermobility Syndrome”. The American Journal of Medicine. Elsevier BV. doi:10.1016/s0002-9343(03)00235-3.
- Reychler, Gregory, Giuseppe Liistro, Gérald E. Piérard, Trinh Hermanns‐Lê, and Daniel Manicourt. 2018. “Inspiratory Muscle Strength Training Improves Lung Function in Patients with the Hypermobile Ehlers–danlos Syndrome: A Randomized Controlled Trial”. American Journal of Medical Genetics Part A. Wiley. doi:10.1002/ajmg.a.61016.
- Ayres, J G, F M Pope, J F Reidy, and T J Clark. 1985. “Abnormalities of the Lungs and Thoracic Cage in the Ehlers-danlos Syndrome.”. Thorax. BMJ. doi:10.1136/thx.40.4.300.
- Morgan, A W, S B Pearson, S Davies, H C Gooi, and H A Bird. 2007. “Asthma and Airways Collapse in Two Heritable Disorders of Connective Tissue”. Annals of the Rheumatic Diseases. BMJ. doi:10.1136/ard.2006.062224.
- Chatzoudis, D, TJ Kelly, J Lancaster, and TM Jones. 2015. “Upper Airway Obstruction in a Patient with Ehlers–danlos Syndrome”. The Annals of the Royal College of Surgeons of England. Royal College of Surgeons of England. doi:10.1308/003588414x14055925061793.
- Ayres JG, Pope FM, Reidy JF, Clark TJ. Abnormalities of the lungs and thoracic cage in the Ehlers-Danlos syndrome. Thorax. 1985 Apr;40(4):300-5. doi: 10.1136/thx.40.4.300.
- Morgan AW, Pearson SB, Davies S, Gooi HC, Bird HA. Asthma and airways collapse in two heritable disorders of connective tissue. Ann Rheum Dis. 2007 Oct;66(10):1369-73. doi: 10.1136/ard.2006.062224. Epub 2007 Apr 5.
- Gazit Y, Nahir AM, Grahame R, Jacob G. Dysautonomia in the joint hypermobility syndrome. Am J Med. 2003 Jul;115(1):33-40. doi: 10.1016/s0002-9343(03)00235-3.
- Reychler G, Liistro G, Pierard GE, Hermanns-Le T, Manicourt D. Inspiratory muscle strength training improves lung function in patients with the hypermobile Ehlers-Danlos syndrome: A randomized controlled trial. Am J Med Genet A. 2019 Mar;179(3):356-364. doi: 10.1002/ajmg.a.61016. Epub 2018 Dec 20.
- Hakim AJ, Grahame R. Non-musculoskeletal symptoms in joint hypermobility syndrome. Indirect evidence for autonomic dysfunction? Rheumatology (Oxford). 2004 Sep;43(9):1194-5. doi: 10.1093/rheumatology/keh279. No abstract available.
- 2021. "Dyspnea in Hypermobile Ehlers-Danlos Syndrome and Hypermobility Spectrum Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04972565.
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