Actively Recruiting
An Interventional Study to Evaluate the Impact of Blood Flow Restriction Training on Muscle, Bone, and Quality of Life in Adults With Osteogenesis Imperfecta Type I
Led by University Hospital, Ghent · Updated on 2026-03-17
40
Participants Needed
1
Research Sites
67 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Ghent
Lead Sponsor
B
Brittle Bone Society
Collaborating Sponsor
AI-Summary
What this Trial Is About
Background: Due to fear of injury and risk of fractures, many people with osteogenesis imperfecta (OI) avoid vigorous exercise that is likely to improve muscle and bone weakness common in this disorder. Low-intensity muscle strength training with blood flow restriction (BFR-LI) via an inflatable cuff leads to similar improvements in muscle size and strength to conventional high-intensity strength training but has not been applied in OI.Objectives: To evaluate the effect of BFR-LI on muscle and bone health and quality of life in adults with OI type I.Methods: For this randomized controlled trial, 40 adults (18-65y) with OI type I will be recruited. Exclusion criteria include pregnancy or \<6 months postpartum, deep vein thrombosis, acute fractures, recent surgery, regular vigorous exercise, or contraindications to exercise. Participants will be randomly assigned to perform BFR-LI or standard care. The BFR-LI group will perform home-based exercises 2-3 times/week for 12 weeks at low training intensity (20% of 1-repetition maximum) which will increase every 4 weeks. Muscle and bone parameters will be evaluated using scans (peripheral computed tomography and dual-energy x-ray absorptiometry) and muscle strength tests, and quality of life (mental well-being, participation, pain and fatigue) by the PROMIS questionnaire at baseline, immediately, three, and six months after training.
CONDITIONS
Official Title
An Interventional Study to Evaluate the Impact of Blood Flow Restriction Training on Muscle, Bone, and Quality of Life in Adults With Osteogenesis Imperfecta Type I
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of osteogenesis imperfecta type I
- Age between 18 and 65 years old
You will not qualify if you...
- Edema, recent surgery, or acute fractures in lower limbs
- Pregnancy or less than 6 months postpartum
- Current or past deep vein thrombosis
- Cardiovascular, respiratory, or neuromuscular diseases
- Recent cardiovascular events or untreated hypertension
- Diseases affecting vascular function such as diabetes
- Vigorous strength training in the year before the study
- Other contraindications to performing exercise
AI-Screening
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Trial Site Locations
Total: 1 location
1
Ghent University (Hospital) - department of endocrinology and department of rehabilitation sciences and physiotherapy
Ghent, Belgium, 9000
Actively Recruiting
Research Team
M
Marie Coussens, PhD
CONTACT
P
Patrick Calders, Prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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