NCT03665051

Electrical Stimulation of Human Myocytes in Microgravity

Electrical Stimulation of Human Myocytes in Microgravity: An In Vitro Model to Evaluate Therapeutics to Counteract Muscle Wasting (microG)

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 75 (estimated)
• Sponsor: AdventHealth Translational Research Institute · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the changes of muscle, in microgravity. Which will help explain the health benefits of exercise. There are tests that can be done to tell researchers more about the human body, such as a dual energy x-ray absorptiometry (DEXA) scan, which measures body composition (fat and lean body mass). The use of muscle testing and a Handgrip test can tell us about the strength and power within an individual's muscles. A VO2 max test helps us understand the aerobic fitness level of an individual and one of the most important aspects of this study are muscle cells. A muscle biopsy allows us to obtain muscle cells from the thigh, which will be sent into space by a rocket. Researchers will study these muscle cells in a low gravity environment aboard the International Space Station. Studying the muscle cells under those conditions will potentially mimic an accelerated aging process, which will help researchers better understand muscle wasting in the elderly.

Conditions

• Sarcopenia

Interventions

Type	Name	Description
PROCEDURE	Muscle Tissue Biopsy	A biopsy of the Vastus Lateralis muscle will be performed on the left leg using the Bergstrom technique.The skin will be incised (approximately 0.75 cm) with a #11 scalpel, and the Bergstrom needle will be inserted into the Vastus Lateralis. Approximately 150 mg of muscle tissue will be obtained under suction. After the biopsy, pressure will be applied to stop bleeding and the skin will be closed with Steri strips (suture(s) if allergy to steri strips and removal 7-10 days post biopsy). A sterile dressing will be applied. Ace bandage may also be used along with applied pressure and an ice pack for any swelling and pain relief.
OTHER	Maximal Oxygen Consumption (V02max)	Aerobic fitness will be determined by measuring maximal O2 consumption (VO2max) during a stationary bicycle exercise test. Heart rate, blood pressure and ECG will be recorded throughout this test. Subjects will breathe through a low resistance mouthpiece and wear a nose clip. Expired gases will be measured by indirect calorimetry and heart rate monitored by a portable heart rate monitor. Following a standardized warm up, subjects will begin exercising at a moderate intensity with the workload increased every minute until the subject can no longer continue. A leveling-off (plateau) or decline in oxygen uptake should be demonstrated in order to be reasonably sure that a subject has achieved the maximum capacity for aerobic metabolism.

Timeline

• Start date: 2019-01-25
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2018-09-11
• Last updated: 2025-06-11

Locations

1 site across 1 country: United States