Status:
COMPLETED
Bed Rest Study SBI 2023
Lead Sponsor:
Science and Research Centre Koper
Collaborating Sponsors:
Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)
Izola General Hospital
Conditions:
Healthy Aging
Physical Inactivity
Eligibility:
MALE
18-75 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 22 2023
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT06141291
Start Date
August 21 2023
End Date
October 22 2023
Last Update
November 21 2023
Active Locations (1)
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1
SRC Koper
Koper, Slovenia, 6000