Blood flow restriction training to improve muscle, bone, and quality of life in adults with osteogenesis imperfecta type I
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
NA · University Hospital, Ghent · NCT07478224
This trial will test whether a 12-week home-based low-intensity blood flow restriction exercise program can increase muscle and bone strength and improve quality of life for adults with osteogenesis imperfecta type I.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University Hospital, Ghent (other) |
| Locations | 1 site (Ghent) |
| Trial ID | NCT07478224 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial will recruit 40 adults aged 18-65 with OI type I and randomly assign them to low-intensity blood flow restriction (BFR-LI) exercise or standard care. The BFR-LI group will perform home-based exercises 2-3 times per week for 12 weeks using an inflatable cuff to partially restrict blood flow during low-load strength exercises. Primary outcomes include changes in muscle size and strength, bone health measures, and patient-reported quality of life, with exclusions for pregnancy, recent fractures or surgery, deep vein thrombosis, significant cardiovascular or vascular disease, and recent vigorous strength training. The protocol combines remote home exercise sessions with in-person baseline and follow-up visits at Ghent University Hospital.
Who should consider this trial
Good fit: Ideal candidates are ambulatory adults 18-65 with confirmed osteogenesis imperfecta type I who are not currently engaged in regular vigorous strength training and have no contraindications to exercise.
Not a fit: People with acute fractures, recent lower-limb surgery, active or prior deep vein thrombosis, significant cardiovascular or vascular disease, pregnancy or recent postpartum, or those already doing high-intensity strength training are unlikely to benefit or will be excluded.
Why it matters
Potential benefit: If successful, this approach could let people with OI type I build muscle and bone using gentler, lower-load exercises, potentially improving mobility and daily functioning with less fracture risk than high-intensity training.
How similar studies have performed: Low-intensity blood flow restriction training has produced muscle size and strength gains comparable to high-intensity training in other populations, but it has not previously been tested in people with OI.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ghent
- Ghent University (Hospital) - department of endocrinology and department of rehabilitation sciences and physiotherapy — Ghent, Belgium (RECRUITING)
Study contacts
- Principal investigator: Charlotte Verroken, PhD, MD — University Hospital, Ghent
- Study coordinator: Marie Coussens, PhD
- Email: marie.coussens@ugent.be
- Phone: +32 (0)9 332 69 24
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Osteogenesis Imperfecta, Type I, Blood flow restriction, Exercise, Osteogenesis Imperfecta, Muscle, Bone, Quality of life