NCT Number: NCT07478224
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Ghent, 9000, Belgium
Location status: Recruiting
Marie Coussens, PhD
CONTACT
Marie Coussens, PhD
SUB_INVESTIGATOR
Patrick Calders, Prof.
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Edema; Recent surgery; Acute fractures
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).
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).
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)
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).
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).
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).
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).
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).
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).
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.
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.
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.
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
Contact information is provided by the study sponsor or research team.
Marie Coussens, PhD
CONTACT
Patrick Calders, Prof.
CONTACT
University Hospital, Ghent
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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