Clinical Trials Directory

Trials / Completed

CompletedNCT06141291

Bed Rest Study SBI 2023

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
29 (actual)
Sponsor
Science and Research Centre Koper · Academic / Other
Sex
Male
Age
18 Years – 75 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTHigh protein dietTest 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_TESTOGTTAssessment 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.

Timeline

Start date
2023-08-21
Primary completion
2023-10-22
Completion
2023-10-22
First posted
2023-11-21
Last updated
2023-11-21

Locations

1 site across 1 country: Slovenia

Source: ClinicalTrials.gov record NCT06141291. Inclusion in this directory is not an endorsement.