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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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Osteogenesis imperfecta type I, aged between 18 and 65 years old

Locations
Other Locations
Belgium
Ghent University (Hospital) - department of endocrinology and department of rehabilitation sciences and physiotherapy
RECRUITING
Ghent
Contact Information
Primary
Marie Coussens, PhD
marie.coussens@ugent.be
+32 (0)9 332 69 24
Backup
Patrick Calders, Prof.
Patrick.calders@ugent.be
Time Frame
Start Date: 2025-08-19
Estimated Completion Date: 2026-12
Participants
Target number of participants: 40
Treatments
Experimental: Training group
No_intervention: Control group
Usual care (control group): this may consist of medication intake (e.g., bisphosphonates); physical therapy (low intensity strength training, mobility, coordination, physical activity programs and recommendations); nutritional support (balanced diet) or psychological support (counseling and physical activity counseling). After six months, participant can choose whether or not they join the intervention group or remain in the control group.
Sponsors
Collaborators: University Ghent, Osteogenesis Imperfecta Federation, Brittle Bone Society
Leads: University Hospital, Ghent

This content was sourced from clinicaltrials.gov