Clinical trial NCT06141291: Bed Rest Study SBI 2023
Official title: Neuromuscular Decline After Physical Inactivity: a Comparison of Younger and Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Aging
Physical Inactivity
Lead sponsor: Science and Research Centre Koper
Sponsor class: OTHER
Collaborators: name: Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)
name: Izola General Hospital
name: University of Padova
name: University of Udine
name: University of Pavia
name: University of Trieste
First posted: 2023-11-21
Enrollment: 29
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Insulin sensitivity
timeFrame: 10 days
Secondary outcomes:
measure: Muscle mass
timeFrame: 10 day
measure: Muscle force
timeFrame: 10 days
measure: Neuromuscular junction stability
timeFrame: 10 days
Other outcomes:
Locations:
city: Koper
country: Slovenia
facility: SRC Koper
Study officials:
affiliation: Science and Research Centre Koper
name: Rado Pišot, PhD
role: PRINCIPAL_INVESTIGATOR
References: