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Assessment of a novel strategy to attenuate muscle mass loss during 2 weeks of bed rest


- candidate number27098
- NTR NumberNTR6378
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-apr-2017
- Secondary IDsMETC173014 
- Public TitleAssessment of a novel strategy to attenuate muscle mass loss during 2 weeks of bed rest
- Scientific TitleAssessment of a novel strategy to attenuate muscle mass loss during 2 weeks of bed rest
- ACRONYMBed Rest & Muscle Mass
- hypothesisWe hypothesize that applying BFR will decrease the loss in leg muscle mass during 2 weeks of bed rest.
- Healt Condition(s) or Problem(s) studiedImmobilization, Suprastructure complications
- Inclusion criteria Healthy males
Age between 18 and 35 y
BMI between 18.5 and 30 kg/m2
- Exclusion criteria Smoking
Type 2 Diabetes Mellitus
Any back/leg/knee/neck/postural complaints

Any history and/or family history of thrombosis

All co-morbidities interacting with mobility and muscle metabolism of the lower limbs 
(e.g. arthritis, spasticity/rigidity, all neurological disorders and paralysis)
Myocardial infarction within the last 3 years
Use of certain anti-coagulants (use of thrombocyte aggregation inhibitors such as Ascal, 
acetylsalicylic acid, aspirin and carbasalaatcalcium is permitted. Use of other thrombocyte aggregation inhibitors will be discussed with the responsible physician)

Performing regular resistance training (3+ times per week, carrying out progressive training) in the previous 6 months
Hypertension (according to WHO criteria) and/or cardiovascular disease
A history of deep vein thrombosis (DVT) in the leg
Having donated blood in the 3 months prior to the study
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlNot applicable
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jul-2017
- planned closingdate31-dec-2018
- Target number of participants12
- InterventionsThe main intervention: the amount of muscle mass that is lost following 2 weeks of bed rest will be assessed and whether BFR can be applied to effectively preserve muscle mass and strength during bed rest. In addition, we would like to assess the effects of 2 weeks of bed rest on changes in body composition and adipose tissue function and gain insights into the (potential) cellular mechanisms that occur during a period of bed rest.
- Primary outcomeTo assess the amount of muscle mass that is lost following 2 weeks of bed rest and whether BFR can be applied to effectively preserve muscle mass and strength during bed rest.
- Secondary outcomeTo assess differences in muscle fiber cross-sectional area (CSA), satellite cell content/activation, muscle fiber vascularization, muscle protein synthesis rates between both legs (BFR vs control), muscle strength, whole-body fat mass, adipose tissue gene expression and oral glucose tolerance before and after 2 weeks of bed rest.
- TimepointsPre and post 2-wk bed rest.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Cas Fuchs
- CONTACT for SCIENTIFIC QUERIES Cas Fuchs
- Sponsor/Initiator Maastricht University
- Funding
(Source(s) of Monetary or Material Support)
Maastricht University
- Publicationsn/a
- Brief summarySeveral situations, such as spaceflight, injury and illness, necessitate prolonged periods of muscle disuse or unloading in otherwise healthy humans. Under such conditions, there is a progressive loss of skeletal muscle mass and strength, a reduction in insulin sensitivity, a decline in basal metabolic rate, and a concomitant increase in body fat mass. As a consequence, performance and metabolic health detriments ensue rapidly, providing an immediate need for effective countermeasures in order to minimize the subsequent rehabilitation efforts that are required.
It has previously been observed that applying blood flow restriction (BFR) during 2-weeks of immobilization of the lower extremity attenuated the decrease in muscle strength and effectively diminished the disuse atrophy of thigh muscles. These findings suggest that applying BFR may be an effective strategy to attenuate skeletal muscle mass loss during a period of bed rest.
- Main changes (audit trail)
- RECORD14-apr-2017 - 9-sep-2017


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