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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity Hospital, Ghent

About this trial

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

Qualifiers

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

Disqualifiers

Pregnancy/<6 months postpartum

Deep vein thrombosis (now or history of)

Cardiovascular, respiratory, or neuromuscular diseases

Recent cardiovascular events/untreated hypertension

Trial design

Treatments tested in this trial

  • Blood flow restriction training

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University Hospital, Ghent

Lead sponsor

Brittle Bone Society

Collaborator

Osteogenesis Imperfecta Federation

Collaborator

University Ghent

Collaborator