Trial Outcomes & Findings for Muscle Capillarization and Sarcopenia (NCT NCT03984994)

Last Updated: 2025-10-29

Results Overview

Change in the number of capillaries per unit of skeletal muscle tissue after resistance training. The aims of the study were to compare responses to resistance training between arms/groups. Therefore, only the resistance training-induced change (post minus pre-resistance training) is assessed and analyzed as this is the primary outcome for each arm.

Recruitment status

COMPLETED

Study phase

Target enrollment

14 participants

Primary outcome timeframe

3 months (post minus pre-resistance training)

Results posted on

2025-10-29

Participant Flow

Participants are assigned to groups upon completion of baseline testing.

Participant milestones

Participant milestones
Measure	Aerobic Exercise Training Followed by Resistance Training Participants in this arm will undergo 3 months of aerobic exercise training, followed by 3 months of strength training Aerobic exercise training: 3 months of center-based, supervised treadmill exercise Strength training: 3 months of center-based, supervise strength training	Resistance Training Followed by Aerobic Exercise Training Participants in this arm will undergo 3 months of strength training, followed by 3 months of aerobic exercise training Aerobic exercise training: 3 months of center-based, supervised treadmill exercise Strength training: 3 months of center-based, supervise strength training
Overall Study STARTED	7	7
Overall Study COMPLETED	5	6
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Aerobic Exercise Training Followed by Resistance Training Participants in this arm will undergo 3 months of aerobic exercise training, followed by 3 months of strength training Aerobic exercise training: 3 months of center-based, supervised treadmill exercise Strength training: 3 months of center-based, supervise strength training	Resistance Training Followed by Aerobic Exercise Training Participants in this arm will undergo 3 months of strength training, followed by 3 months of aerobic exercise training Aerobic exercise training: 3 months of center-based, supervised treadmill exercise Strength training: 3 months of center-based, supervise strength training
Overall Study Withdrawal by Subject	2	1

Baseline Characteristics

Muscle Capillarization and Sarcopenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aerobic Exercise Training Followed by Resistance Training n=7 Participants Participants in this arm will undergo 3 months of aerobic exercise training, followed by 3 months of strength training Aerobic exercise training: 3 months of center-based, supervised treadmill exercise Strength training: 3 months of center-based, supervise strength training	Resistance Training Followed by Aerobic Exercise Training n=7 Participants Participants in this arm will undergo 3 months of strength training, followed by 3 months of aerobic exercise training Aerobic exercise training: 3 months of center-based, supervised treadmill exercise Strength training: 3 months of center-based, supervise strength training	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Age, Continuous	78 years STANDARD_DEVIATION 4 • n=5 Participants	73 years STANDARD_DEVIATION 6 • n=7 Participants	75 years STANDARD_DEVIATION 6 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants	7 participants n=7 Participants	14 participants n=5 Participants
Appendicular Lean Mass (kg)	17.1 kilograms STANDARD_DEVIATION 1.9 • n=5 Participants	19.3 kilograms STANDARD_DEVIATION 5.4 • n=7 Participants	18.4 kilograms STANDARD_DEVIATION 4.4 • n=5 Participants
Quadriceps muscle strength (Newton*meters)	91 Newton*meters STANDARD_DEVIATION 15 • n=5 Participants	107 Newton*meters STANDARD_DEVIATION 30 • n=7 Participants	101 Newton*meters STANDARD_DEVIATION 25 • n=5 Participants

PRIMARY outcome

Timeframe: 3 months (post minus pre-resistance training)

Population: All participants completing the resistance training portion of the intervention in each arm were analyzed. Only data for the resistance training portion of the study are reported (change post-pre training). Data and analyses are not reported for aerobic exercise as this was not part of the aims/outcomes and was only assessed to gauge responses to only RT.

Outcome measures

Outcome measures
Measure	Aerobic Exercise Training Followed by Resistance Training n=5 Participants Participants in this arm will undergo 3 months of aerobic exercise training, followed by 3 months of strength training Aerobic exercise training: 3 months of center-based, supervised treadmill exercise Strength training: 3 months of center-based, supervise strength training	Resistance Training Followed by Aerobic Exercise Training n=6 Participants Participants in this arm will undergo 3 months of strength training, followed by 3 months of aerobic exercise training Aerobic exercise training: 3 months of center-based, supervised treadmill exercise Strength training: 3 months of center-based, supervise strength training
Skeletal Muscle Capillarization	0.4 capillaries per muscle fiber Standard Error 0.1	0.2 capillaries per muscle fiber Standard Error 0.1

PRIMARY outcome

Timeframe: 3 months (post minus pre-resistance training)

Change in the size of the thigh muscles. The aims of the study were to compare responses to resistance training between arms/groups. Therefore, only the resistance training-induced change (post minus pre-resistance training) is assessed and analyzed as this is the primary outcome for each arm.

Outcome measures

Outcome measures
Measure	Aerobic Exercise Training Followed by Resistance Training n=5 Participants Participants in this arm will undergo 3 months of aerobic exercise training, followed by 3 months of strength training Aerobic exercise training: 3 months of center-based, supervised treadmill exercise Strength training: 3 months of center-based, supervise strength training	Resistance Training Followed by Aerobic Exercise Training n=6 Participants Participants in this arm will undergo 3 months of strength training, followed by 3 months of aerobic exercise training Aerobic exercise training: 3 months of center-based, supervised treadmill exercise Strength training: 3 months of center-based, supervise strength training
Quadriceps Muscle Cross-sectional Area	2.5 square centimeters Standard Error 2.0	0.7 square centimeters Standard Error 2.6

SECONDARY outcome

Timeframe: 3 months (post minus pre-resistance training)

Change in the cross-sectional size of individual thigh skeletal muscle fibers. The aims of the study were to compare responses to resistance training between arms/groups. Therefore, only the resistance training-induced change (post minus pre-resistance training) is assessed and analyzed as this is the primary outcome for each arm.

Outcome measures

Outcome measures
Measure	Aerobic Exercise Training Followed by Resistance Training n=5 Participants Participants in this arm will undergo 3 months of aerobic exercise training, followed by 3 months of strength training Aerobic exercise training: 3 months of center-based, supervised treadmill exercise Strength training: 3 months of center-based, supervise strength training	Resistance Training Followed by Aerobic Exercise Training n=6 Participants Participants in this arm will undergo 3 months of strength training, followed by 3 months of aerobic exercise training Aerobic exercise training: 3 months of center-based, supervised treadmill exercise Strength training: 3 months of center-based, supervise strength training
Skeletal Muscle Fiber Size	607 square micrometers Standard Error 108	356 square micrometers Standard Error 227

SECONDARY outcome

Timeframe: 3 months (post minus pre-resistance training)

Change in the strength/force produced by skeletal muscles of the thigh. Only the resistance training-induced change (post minus pre-resistance training) is reported as this is the primary outcome for each arm.

Outcome measures

Outcome measures
Measure	Aerobic Exercise Training Followed by Resistance Training n=5 Participants Participants in this arm will undergo 3 months of aerobic exercise training, followed by 3 months of strength training Aerobic exercise training: 3 months of center-based, supervised treadmill exercise Strength training: 3 months of center-based, supervise strength training	Resistance Training Followed by Aerobic Exercise Training n=6 Participants Participants in this arm will undergo 3 months of strength training, followed by 3 months of aerobic exercise training Aerobic exercise training: 3 months of center-based, supervised treadmill exercise Strength training: 3 months of center-based, supervise strength training
Muscle Strength	12.7 Newton-meters Standard Error 2.3	2.0 Newton-meters Standard Error 5.8

Adverse Events

Aerobic Exercise Training Followed by Resistance Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Resistance Training Followed by Aerobic Exercise Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Steven J. Prior

University of Maryland

Phone: 301-405-2483

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place