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

Ghent University Hospital (UZ)

Status: Enrolling

Conditions: Osteogenesis Imperfecta, Type I

Treatments: Other: Blood flow restriction training

Study type: Interventional

Funder types: Other

Identifiers

NCT07478224

ONZ-2024-0333

Details and patient eligibility

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Training group

Experimental group

Treatment:

Other: Blood flow restriction training

Control group

No Intervention group

Description:

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.