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Bed Rest Study SBI 2023

Neuromuscular Decline After Physical Inactivity: a Comparison of Younger and Older Adults

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06141291
Enrollment
29
Registered
2023-11-21
Start date
2023-08-21
Completion date
2023-10-22
Last updated
2023-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Aging, Physical Inactivity

Brief summary

The study will consist of three groups of subjects. Ten young male subjects (18-30 years) will lie supine for 21 days, 10 older male subjects (65+ years) will lie supine for 10 days, and a third group of 10 older male subjects (65+ years) will also lie supine for 10 days but will receive interventions (see below) to counteract the physical changes caused by supine lying. All three groups will be bedridden in the premises of Izola General Hospital. Subjects will be housed in 5-bed rooms at the hospital and will receive 24-hour medical care, proper hygiene, nutrition, passive exercise, Internet, a relaxing environment, and visits. After their stay, subjects return home but receive 21 days of care at local fitness centers. Rehabilitation consists of interval training, in which subjects perform high-intensity exercise for 4 times 5 minutes. A number of important health parameters are measured before, during, and after bed rest. Some of these measurements will be invasive (blood and muscle sampling), for which appropriate medical personnel, sterile instruments, and environment will be available. Measurements will include normal voluntary efforts (indoor cycling, various jumps, short stretches) and electrically evoked muscle contractions (electrical stimulation with single impulses). All tests are normal tests and come from normal lifestyles and routine medical examinations.

Interventions

DIETARY_SUPPLEMENTHigh protein diet

Test the ability of high protein diet (1.4 g protein/kg/day) with branched chain amino acid and cysteine supplementation to decrease bed rest induced muscle atrophy, glutathione depletion and insulin resistance in old subjects.

DIAGNOSTIC_TESTOGTT

Assessment of changes in insulin sensitivity (Oral Glucose Tolerance test and muscle insulin signalling: immunofluorescence and western blot of GLUT-4, IRS-1, MPP/TIMP, etc.) following bed rest in old and young subjects.

Sponsors

Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)
CollaboratorUNKNOWN
Izola General Hospital
CollaboratorOTHER
University of Padova
CollaboratorOTHER
University of Udine
CollaboratorOTHER
University of Pavia
CollaboratorOTHER
University of Trieste
CollaboratorOTHER
Science and Research Centre Koper
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* age: for young arm (18-35), for old arm (65-75) * BMI: 22 in 32 kg/m2 * appendicular muscle mass \> 7,23 kg/m2

Exclusion criteria

* serious acute or chronic diseases: skeletal, cancer, cardiovascular, metabolic, neuromuscular and psychiatric; * cardiovascular disease detected on ECG examination; * allergies to the active substances used in the study; * problems with digestion of the active substances; * frequent diarrhea and vomiting; * arterial hypertension (\>140/90 mmHg); * psychological problems; * susceptibility to deep vein thrombosis (D-dimer \< 500 μg/L) * poor orthostatic tolerance (frequent dizziness when changing position, especially when rising from a supine position); * venous abnormalities that would cause difficulty in drawing blood; * a large blood volume (more than 300 ml) in the last 3 months prior to the start of the project; * problems with excessive consumption of alcoholic beverages; * active smoking; * Previous participation in any biomedical research in the last 3 months prior to the start of this study; * a communicable disease before the start of the project; * any ferromagnetic implant.

Design outcomes

Primary

MeasureTime frameDescription
Insulin sensitivity10 daysAssessment in changes in insulin sensitivity will be made with the use of Oral Glucose Tolerance test (OGTT).

Secondary

MeasureTime frameDescription
Muscle mass10 dayMuscle mass will be measured with bioimpedance and with DXA.
Muscle force10 daysQuadriceps femoris maximal voluntary contractions (MVC) in isometric conditions at knee angle set at 30 deg flexion and hip fixed at 90 deg flexion using a custom-made knee dynamometer fitted with a load cell (RS 206-0290).
Neuromuscular junction stability10 daysWe will evaluate the presence of NMJ stability by analysing: AChR subunits expression

Countries

Slovenia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026