Trial Outcomes & Findings for Role of Skeletal Muscle Nitric Oxide Production in Age-related Fatigue and Fatigability (NCT NCT01059994)

Results Overview

Muscle fatigue was tested before and after 1 week of placebo/sildenafil (25mg/day) treatment. Subjects were asked to perform maximum effort isokinetic knee extensions until force production reached 50% of their MVC (maximum voluntary contraction). Data was collected as number of successful repetitions completed between start and 50% MVC. Data is presented as percent change in repetitions (1 week of treatment / baseline).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

baseline to 1 week

Results posted on

2019-02-11

Participant Flow

Males in the age groups of 20-35 and 60-80 were recruited. Subjects were screened and enrolled at the University of Texas Medical Branch in the Institute for Translational Sciences Clinical Research Center (ITS-CRC).

Participants who failed screening, did not otherwise meet inclusion criteria, or decided not to participate were excluded before being assigned to intervention groups.

Participant milestones

Participant milestones
Measure	Sildenafil Placebo Young Sildenafil placebo: Oral, daily, 1 week.	Sildenafil Young Sildenafil: oral, 25mg, daily for 1 week	Sildenafil Placebo Older Sildenafil placebo: Oral, daily, 1 week.	Sildenafil Older Sildenafil: oral, 25mg, daily for 1 week
Overall Study STARTED	3	2	3	4
Overall Study COMPLETED	3	2	3	3
Overall Study NOT COMPLETED	0	0	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Role of Skeletal Muscle Nitric Oxide Production in Age-related Fatigue and Fatigability

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Sildenafil Young n=3 Participants Sildenafil placebo: Oral, daily, 1 week.	Sildenafil Young n=2 Participants Sildenafil: oral, 25mg, daily for 1 week	Placebo Sildenafil Older n=3 Participants Sildenafil placebo: Oral, daily, 1 week.	Sildenafil Older n=4 Participants Sildenafil: oral, 25mg, daily for 1 week	Total n=12 Participants Total of all reporting groups
Age, Customized	25 years STANDARD_DEVIATION 6 • n=5 Participants	29 years STANDARD_DEVIATION 4 • n=7 Participants	63 years STANDARD_DEVIATION 5 • n=5 Participants	74 years STANDARD_DEVIATION 4 • n=4 Participants	51 years STANDARD_DEVIATION 23 • n=21 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	12 Participants n=21 Participants

PRIMARY outcome

Timeframe: baseline to 1 week

Muscle fatigue was tested before and after 1 week of placebo/sildenafil (25mg/day) treatment. Subjects were asked to perform maximum effort isokinetic knee extensions until force production reached 50% of their MVC (maximum voluntary contraction). Data was collected as number of successful repetitions completed between start and 50% MVC. Data is presented as percent change in repetitions (1 week of treatment / baseline).

Outcome measures

Outcome measures
Measure	Placebo Sildenafil Young n=3 Participants Sildenafil placebo: Oral, daily, 1 week.	Sildenafil Young n=2 Participants Sildenafil: oral, 25mg, daily for 1 week	Placebo Sildenafil Older n=3 Participants Sildenafil placebo: Oral, daily, 1 week.	Sildenafil Older n=3 Participants Sildenafil: oral, 25mg, daily for 1 week
Change in Muscle Fatigue After 1 Week of Placebo or Sildenafil	107 percent change of successful repetitions Standard Deviation 5	115 percent change of successful repetitions Standard Deviation 10	54 percent change of successful repetitions Standard Deviation 31	158 percent change of successful repetitions Standard Deviation 27

SECONDARY outcome

Timeframe: 1 week

Skeletal muscle protein synthesis, measured as the fractional synthesis rate (the percent of the total synthesized per unit time) after 1 week of either Placebo or Sildenafil (25 mg/day). Example: if FSR = 0.06 hr-1 it means that 6% of proteins in a given sample were synthesized in the last hour or proteins is synthesized at 6% per hour. A higher rate means that more synthesis is occurring.

Outcome measures

Outcome measures
Measure	Placebo Sildenafil Young n=3 Participants Sildenafil placebo: Oral, daily, 1 week.	Sildenafil Young n=2 Participants Sildenafil: oral, 25mg, daily for 1 week	Placebo Sildenafil Older n=3 Participants Sildenafil placebo: Oral, daily, 1 week.	Sildenafil Older n=3 Participants Sildenafil: oral, 25mg, daily for 1 week
Protein Synthesis Rate After 1 Week of Sildenafil or Placebo	0.06 fraction of proteins synthesized/hr Standard Deviation 0.03	0.11 fraction of proteins synthesized/hr Standard Deviation 0.04	0.04 fraction of proteins synthesized/hr Standard Deviation 0.01	0.10 fraction of proteins synthesized/hr Standard Deviation 0.03

Adverse Events

Placebo Sildenafil Young

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sildenafil Young

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Sildenafil Older

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sildenafil Older

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

Melinda Sheffield-Moore

University of Texas Medical Branch

Phone: 4097728126

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place