Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
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

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

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of osteogenesis imperfecta type I
  • Age between 18 and 65 years old
Not Eligible

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

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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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