Osteogenesis Imperfecta, Type INCT07478224
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
A study testing Blood flow restriction training in people with Osteogenesis Imperfecta, Type I, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Osteogenesis Imperfecta, Type I
- What is being tested?
- Blood flow restriction training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 19 Aug 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Osteogenesis imperfecta type I, aged between 18 and 65 years old
Who cannot join
- 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
Show all 9Show fewer
- Diseases affecting vascular function (e.g., diabetes)
- Vigorous strength training in year before study
- Other contraindications to perform exercise
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Patrick Calders, Prof. contact
Belgium1 site, 1 recruiting
- Recruiting
Ghent University (Hospital) - department of endocrinology and department of rehabilitation sciences and physiotherapy
Ghent, 9000
Marie Coussens, PhD, +32 9 332 69 24, marie.coussens@ugent.be
Patrick Calders, Prof., Patrick.Calders@ugent.be
About this study
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
- Being tested
- Blood flow restriction training
- Keywords
- Blood flow restriction, Exercise, Osteogenesis Imperfecta, Muscle, Bone, Quality of life
- Medical subject headings
- Osteogenesis Imperfecta, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood flow restriction trainingOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Training group | Experimental | Not described Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Indirect 1RM measurements (via 20RM; dynamic muscle strength; kg) of quadriceps (squats), hamstrings (knee flexion), and calves (toe stands)
Measured: 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
Handheld dynamometry of quadriceps, hamstrings, and calves (isometric muscle strength; N).
Measured: 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
Peak power (kW) during the chair rise test, single two leg jumping, and heel rise test (mechanography; Leonardo Mechanograph; Novotec Medical Inc., Pforzheim, Germany; dynamic muscle strength).
Measured: 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
Bone mass (bone mineral content, g) will be determined through whole body/lumbar spine/bilateral femoral neck DXA measurements and 3D shaper-software (3D-shaper Medical 2025).
Measured: 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
Bone geometry (bone area, cm2) will be determined through whole body/lumbar spine/bilateral femoral neck DXA measurements and 3D shaper-software (3D-shaper Medical 2025).
Measured: 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
Bone density (areal bone mineral density, g/cm2) will be determined through whole body/lumbar spine/bilateral femoral neck DXA measurements and 3D shaper-software (3D-shaper Medical 2025).
Measured: 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
Estimates of bone strength (mm3) will be determined through whole body/lumbar spine/bilateral femoral neck DXA measurements and 3D shaper-software (3D-shaper Medical 2025).
Measured: Will be evaluated four times (at baseline, immediately, three, and six months after training (intervention group)/ 12 weeks of standard care (control group))
Quality of life
Different domains of quality of life will be measured using following aspects of the Patient-Reported Outcomes Measurement Information System (PROMIS), based on the recommendations of Nijhuis et al. (2021) for the comprehensive assessment of OI: (a) pain: PROMIS - pain interference and pain intensity subscales; (b) Fatigue: PROMIS - fatigue; (c) Emotional well-being: PROMIS - anxiety and depression subscales; (d) Participation: PROMIS - ability to participate in social roles and activities and PROMIS - satisfaction with social participation. Raw scores range from 8 to 40 and can be converted to T scores, except for (a) pain intensity of which the raw score ranges from 0 to 10. Higher scores on (a), (b), and (c) indicate higher pain interference/intensity, higher fatigue, and higher anxiety/depression levels, respectively. Higher scores on (d) indicate higher functional participation/satisfaction with social participation.
Measured: Will be evaluated four times (at baseline, immediately, three, and six months after training (intervention group)/ 12 weeks of standard care (control group))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start19 Aug 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteogenesis Imperfecta, Type IStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Brittle Bone Society, Osteogenesis Imperfecta Federation, University Ghent
- Responsible party
- Principal investigator, Endocrinologie, University Hospital, Ghent
- Investigators
- Charlotte Verroken, PhD, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07478224
- Sponsor's protocol ID
- ONZ-2024-0333
- Status last verified
- Jul 2025
- First submitted
- 14 Jul 2025
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07478224
- Acronym / sponsor ID
- ONZ-2024-0333
- Conditions
- Osteogenesis Imperfecta, Type I
- Keywords
- Blood flow restriction, Exercise, Osteogenesis Imperfecta, Muscle, Bone, Quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Brittle Bone Society, Osteogenesis Imperfecta Federation, University Ghent
- Study start
- 19 Aug 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Osteogenesis imperfecta type I, aged between 18 and 65 years old
Key exclusion criteria (9 listed)
- Lower limbs:
- Edema; Recent surgery; Acute fractures
- Pregnancy/<6 months postpartum
- Deep vein thrombosis (now or history of)
- Cardiovascular, respiratory, or neuromuscular diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood flow restriction trainingThe 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). | Other | Training group |
Primary outcome
Muscle mass
Time frame: Will be evaluated four times (at baseline, immediately, three, and six months after training (intervention group)/ 12 weeks of standard care (control group))
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).
8 secondary outcomes
Other muscle parameters: muscle strength measurements
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Will be evaluated four times (at baseline, immediately, three, and six months after training (intervention group)/ 12 weeks of standard care (control group))
Quality of life
Time frame: Will be evaluated four times (at baseline, immediately, three, and six months after training (intervention group)/ 12 weeks of standard care (control group))
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patrick Calders, Prof. contact
Charlotte Verroken, PhD, MD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood flow restriction training in people with Osteogenesis Imperfecta, Type I, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie Coussens, PhD (+32 (0)9 332 69 24, marie.coussens@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle mass (time frame: Will be evaluated four times (at baseline, immediately, three, and six months after training (intervention group)/ 12 weeks of standard care (control group))). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.