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

NCT07478224 | Recruiting

• 1 other identifier: ONZ-2024-0333
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteogenesis Imperfecta, Type I

Keywords

Blood flow restriction; Exercise; Osteogenesis Imperfecta; Muscle; Bone; Quality of life

Outcome Measures

Primary Outcomes (1)

• Muscle mass

  Subtotal lean mass (whole body minus head; kg), lean mass of both legs, and arms (as control parameters that could assess any systemic effects of the training) will be measured by dual energy X-ray absorptiometry (DXA; Hologic QDR- Discovery device; software version 2.3.1; Hologic, Bedford, MA, USA).

  Will be evaluated four times (at baseline, immediately, three, and six months after training (intervention group)/ 12 weeks of standard care (control group))

Secondary Outcomes (8)

• Other muscle parameters: muscle strength measurements

  Will be evaluated four times (at baseline, immediately, three, and six months after training (intervention group)/ 12 weeks of standard care (control group))

• Other muscle parameters: muscle strength measurements

  Will be evaluated four times (at baseline, immediately, three, and six months after training (intervention group)/ 12 weeks of standard care (control group))

• Other muscle parameters: muscle strength measurements

  Will be evaluated four times (at baseline, immediately, three, and six months after training (intervention group)/ 12 weeks of standard care (control group))

• Bone parameters

  Will be evaluated four times (at baseline, immediately, three, and six months after training (intervention group)/ 12 weeks of standard care (control group))

• Bone parameters

  Will be evaluated four times (at baseline, immediately, three, and six months after training (intervention group)/ 12 weeks of standard care (control group))

Other Outcomes (3)

• Feedback training

  Immediately after finishing training

• Physical activity

  Will be evaluated four times (at baseline, immediately, three, and six months after training (intervention group)/ 12 weeks of standard care (control group))

• Number of patients with changes in participation to exercise

  Will be evaluated four times (at baseline, immediately, three, and six months after training (intervention group)/ 12 weeks of standard care (control group))

Study Arms (2)

Training group

EXPERIMENTAL

Other: Blood flow restriction training

Control group

NO INTERVENTION

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.

Interventions

Blood flow restriction training OTHER

The validated Smartcuffs PRO will be used. Maximal occlusion pressure (MOP), i.e., the pressure needed to fully occlude blood flow in the limb, is determined using a pulse pressor sensor while lying. 80% of the MOP is used for the training, achieving partial arterial occlusion and total venous occlusion. Resistance exercises (squats, hamstring curls, toe stands) are performed at 20% 1RM and in 4 sets (1x30, 1x15, 1x15, and 1x until failure). Participants will perform the 12-week training program from home, for 2-3x per week with a minimal 48-h interval between each session. After 12 weeks, they have the possibility to train for another 12 weeks (so 24 weeks in total). After each 4 weeks of training, 1RM estimates will be remeasured, to ensure progression of the training. Participants in the control group will have the option to switch to the training group after 6 months. They will be followed up for 6 months (same protocol as intervention group, though without the 9 month-follow-up).

Training group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Brittle Bone Society: collaborator
• Osteogenesis Imperfecta Federation: collaborator
• University Ghent: collaborator

Study Sites (1)

Ghent University (Hospital) - department of endocrinology and department of rehabilitation sciences and physiotherapy

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Osteogenesis Imperfecta; Motor Activity

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Osteochondrodysplasias; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Charlotte Verroken, PhD, MD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie Coussens, PhD

CONTACT

+32 (0)9 332 69 24; marie.coussens@ugent.be

Patrick Calders, Prof.

CONTACT

Patrick.calders@ugent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Baseline measurements: participants and outcome assessor are blinded to intervention at that moment. After these measurements, participants will be randomised in either intervention or control group. They can't be blinded given the nature of the study (blood flow restriction training).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: March 17, 2026
• Study Start: August 19, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 17, 2026

Record last verified: 2025-07

Locations

BE (1)