Trial Outcomes & Findings for Training Induced Muscle Exosome Release (NCT NCT04500769)

NCT ID: NCT04500769

Last Updated: 2024-12-10

Results Overview

Exosomal, muscle, and adipose miR-1 abundance will be quantified at baseline and following an acute bout of resistance exercise by qPCR.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: NA
• Target enrollment: 38 participants
• Primary outcome timeframe: 90 minutes
• Results posted on: 2024-12-10

Participant Flow

Subjects were actively recruited from the University of Kentucky campus as well as from the surrounding Lexington community through local advertisement using IRB approved recruitment flyers or newspaper advertisement. Recruitment occurred between March of 2019 and November 2022.

Consent and baseline assessments were conducted prior to the resistance exercise intervention. Baseline assessments included demographics, medications, personal health and medical history, vitals, and physical activity readiness. Baseline assessment of strength was also conducted for each resistance exercise so that relative intensity could be standardized for each participant. All participants completed the same resistance exercise bout.

Participant milestones

Measure	Acute Resistance Exercise Participants will perform four exercises: squat, knee extension, leg press, and lat pulldown at 80% of 1-RM determined during a previous visit. Acute Resistance Exercise: Participants will perform three sets of eight repetitions, with a 90-120 second rest between sets, with a fourth set performed to failure. All resistance exercise will be performed on pneumatic resistance devices (Keiser Sports Health Equipment, Fresno, CA).
Overall Study STARTED	38
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure

Acute Resistance Exercise Participants will perform four exercises: squat, knee extension, leg press, and lat pulldown at 80% of 1-RM determined during a previous visit. Acute Resistance Exercise: Participants will perform three sets of eight repetitions, with a 90-120 second rest between sets, with a fourth set performed to failure. All resistance exercise will be performed on pneumatic resistance devices (Keiser Sports Health Equipment, Fresno, CA).

Overall Study Withdrawal by Subject

5

Baseline Characteristics

Training Induced Muscle Exosome Release

Baseline characteristics by cohort

Measure	Acute Resistance Exercise n=38 Participants Participants will perform four exercises: squat, knee extension, leg press, and lat pulldown at 80% of 1-RM determined during a previous visit. Acute Resistance Exercise: Participants will perform three sets of eight repetitions, with a 90-120 second rest between sets, with a fourth set performed to failure. All resistance exercise will be performed on pneumatic resistance devices (Keiser Sports Health Equipment, Fresno, CA).
Age, Continuous	28.71 years STANDARD_DEVIATION 5.99 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	37 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	31 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	38 participants n=5 Participants

PRIMARY outcome

Timeframe: 90 minutes

Exosomal, muscle, and adipose miR-1 abundance will be quantified at baseline and following an acute bout of resistance exercise by qPCR.

Outcome measures

Measure	Acute Resistance Exercise n=32 Participants Participants will perform four exercises: squat, knee extension, leg press, and lat pulldown at 80% of 1-RM determined during a previous visit. Acute Resistance Exercise: Participants will perform three sets of eight repetitions, with a 90-120 second rest between sets, with a fourth set performed to failure. All resistance exercise will be performed on pneumatic resistance devices (Keiser Sports Health Equipment, Fresno, CA).
miR-1 Abundance Percent change in serum EV miR-1 with exercise	226 percent change Standard Deviation 313
miR-1 Abundance Percent change in muscle miR-1 with exercise	110 percent change Standard Deviation 82
miR-1 Abundance Percent change in adipose miR-1 with exercise	286 percent change Standard Deviation 464

Adverse Events

Acute Resistance Exercise

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Acute Resistance Exercise n=38 participants at risk Participants will perform four exercises: squat, knee extension, leg press, and lat pulldown at 80% of 1-RM determined during a previous visit. Acute Resistance Exercise: Participants will perform three sets of eight repetitions, with a 90-120 second rest between sets, with a fourth set performed to failure. All resistance exercise will be performed on pneumatic resistance devices (Keiser Sports Health Equipment, Fresno, CA).
Blood and lymphatic system disorders Light headed from blood draw	5.3% 2/38 • Number of events 2 • 3 weeks AEs and SAEs were collected according to the standard definitions used by clinicaltrials.gov.
Nervous system disorders Nausea during exercise	10.5% 4/38 • Number of events 4 • 3 weeks AEs and SAEs were collected according to the standard definitions used by clinicaltrials.gov.
Musculoskeletal and connective tissue disorders Persistent numbness around biopsy site	5.3% 2/38 • Number of events 2 • 3 weeks AEs and SAEs were collected according to the standard definitions used by clinicaltrials.gov.
Skin and subcutaneous tissue disorders Blister from steri-strip	18.4% 7/38 • Number of events 7 • 3 weeks AEs and SAEs were collected according to the standard definitions used by clinicaltrials.gov.

Additional Information

Douglas Long

University of Kentucky

Phone: 859-323-5438

Email: delong2@uky.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place