Bed Rest Study SBI 2023

Not Applicable

Completed

• Conditions: Healthy Aging; Physical Inactivity

• Registration Number: NCT06141291
• Lead Sponsor: Science and Research Centre Koper

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-21
• Study First Submitted: 2023-10-11
• Primary Completion: 2023-10-22
• Study Completion: 2023-10-22
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-15
• Last Update Submitted: 2023-11-15
• Study First Posted: 2023-11-21
• Last Update Posted: 2023-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 29

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Insulin sensitivity	10 days	Assessment in changes in insulin sensitivity will be made with the use of Oral Glucose Tolerance test (OGTT).

Secondary Outcome Measures

Name	Time	Method
Muscle force	10 days	Quadriceps 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).
Muscle mass	10 day	Muscle mass will be measured with bioimpedance and with DXA.
Neuromuscular junction stability	10 days	We will evaluate the presence of NMJ stability by analysing: AChR subunits expression

Trial Locations

Locations (1)

SRC Koper; 🇸🇮 Koper, Slovenia