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

March 12, 2026 updated by: Endocrinologie, University Hospital, Ghent
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • Recruiting
        • Ghent University (Hospital) - department of endocrinology and department of rehabilitation sciences and physiotherapy
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Marie Coussens, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Training group
Other: Blood flow restriction training
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).
No Intervention: Control group
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Will be evaluated four times (at baseline, immediately, three, and six months after training (intervention group)/ 12 weeks of standard care (control group))

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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))
Indirect 1RM measurements (via 20RM; dynamic muscle strength; kg) of quadriceps (squats), hamstrings (knee flexion), and calves (toe stands)
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))
Handheld dynamometry of quadriceps, hamstrings, and calves (isometric muscle strength; N).
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))
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).
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 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).
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 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).
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 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).
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))
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).
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))
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.
Will be evaluated four times (at baseline, immediately, three, and six months after training (intervention group)/ 12 weeks of standard care (control group))

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Feedback training
Time Frame: Immediately after finishing training
Participants will be asked for feedback on the training to optimize its implementation in future in clinical practice. We will do this by one-to-one semi-structured interviews. All interviews will be conducted face-to-face. Open-ended questions will be used to understand the experiences of the participants.
Immediately after finishing training
Physical activity
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))
Physical activity will be measured through the International Physical Activity Questionnaire (IPAQ). This questionnaires measures activity in minutes/week and Metabolic Equivalent of Task (MET)-minutes/week. Based on MET-minutes/week, activities are categorized in light, moderate or vigorous activity. Scores (min/week for each activity, MET-min/week for each activity and total MET-min/week) range between zero and unlimited. The higher the scores, the more active the participant. Additionally, participants will be asked to report any changes in participation to vigorous exercise.
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
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))
Participants will be asked to report any changes in participation to vigorous exercise during the study
Will be evaluated four times (at baseline, immediately, three, and six months after training (intervention group)/ 12 weeks of standard care (control group))

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Ghent

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Ghent
Brittle Bone Society
Osteogenesis Imperfecta Federation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Charlotte Verroken, PhD, MD, University Hospital, Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 19, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 14, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ONZ-2024-0333

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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