NCT07478224 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
| NCT ID | NCT07478224 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Ghent |
| Condition | Osteogenesis Imperfecta, Type I |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-08-19 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-08-19 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Osteogenesis imperfecta type I, aged between 18 and 65 years old Exclusion Criteria: * Lower limbs: Edema; Recent surgery; Acute fractures * Pregnancy/\<6 months postpartum * Deep vein thrombosis (now or history of) * Cardiovascular, respiratory, or neuromuscular diseases * Recent cardiovascular events/untreated hypertension * Diseases affecting vascular function (e.g., diabetes) * Vigorous strength training in year before study * Other contraindications to perform exercise
Contact & Investigator
Charlotte Verroken, PhD, MD
PRINCIPAL INVESTIGATOR
University Hospital, Ghent
Frequently Asked Questions
Who can join the NCT07478224 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Osteogenesis Imperfecta, Type I. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07478224 currently recruiting?
Yes, NCT07478224 is actively recruiting participants. Contact the research team at marie.coussens@ugent.be for enrollment information.
Where is the NCT07478224 trial being conducted?
This trial is being conducted at Ghent, Belgium.
Who is sponsoring the NCT07478224 clinical trial?
NCT07478224 is sponsored by University Hospital, Ghent. The principal investigator is Charlotte Verroken, PhD, MD at University Hospital, Ghent. The trial plans to enroll 40 participants.