Bed Rest Study SBI 2023

Physical Inactivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06141291
• Other study ID #: BEDREST
• Status: Completed
• Phase: N/A
• Start date: August 21, 2023
• Est. completion date: October 22, 2023

Study information

• Verified date: November 2023
• Source: Science and Research Centre Koper
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: October 22, 2023
• Est. primary completion date: October 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Aging
• Physical Inactivity

Intervention

Dietary Supplement:
• High 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 Test:
• OGTT
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.

Locations

Country	Name	City	State
Slovenia	SRC Koper	Koper

Sponsors (7)

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

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin sensitivity	Assessment in changes in insulin sensitivity will be made with the use of Oral Glucose Tolerance test (OGTT).	10 days
Secondary	Muscle mass	Muscle mass will be measured with bioimpedance and with DXA.	10 day
Secondary	Muscle force	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).	10 days
Secondary	Neuromuscular junction stability	We will evaluate the presence of NMJ stability by analysing: AChR subunits expression	10 days