N/A N=18 Randomized Triple-blind Treatment

The Effect of Sildenafil and Tadalafil on Skeletal Muscle and Perceptual Fatigue

Fatigue

Bottom Line

View on ClinicalTrials.gov: NCT01661595 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2018

Primary outcome: Primary: Skeletal Muscle Fatigue as Measured by Biodex 4 Pro After 4 Weeks of Placebo — 59.69; 42.07; 67.17; 63.24 Newton-Meters

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Sildenafil (Drug); tadalafil (Drug); Placebo (Drug)
Age: Adult · 50+ yrs
Sex: All
Sponsor: The University of Texas Medical Branch, Galveston
Primary completion: Jun 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Skeletal Muscle Fatigue as Measured by Biodex 4 Pro After 4 Weeks of Placebo	59.69; 42.07; 67.17; 63.24	—
PRIMARY Skeletal Muscle Fatigue as Measured by Biodex 4 Pro After 4 Weeks of Active Drug	60.90; 42.48; 62.68; 63.25	—
PRIMARY Exercised Induced Fatigability as Measured by Fatigue Rating Scale After 4 Weeks of Placebo	4.33; 2.5; 7.0; 4.75	—
PRIMARY Exercised Induced Fatigability as Measured by Fatigue Rating Scale After 4 Weeks of Active Drug	4.5; 3.5; 5.25; 6.0	—
SECONDARY Maximum Peak Isometric Leg Strength as Measured by Biodex Pro4 After 4 Weeks of Placebo	145.86; 104.17; 149.14; 148.34	—
SECONDARY Maximum Peak Isometric Leg Strength as Measured by Biodex Pro4 After 4 Weeks of Active Drug.	140.09; 110.39; 133.81; 139.96	—
SECONDARY Maximum Peak Isokinetic Leg Strength as Measured by Biodex Pro4 After 4 Weeks of Placebo.	105.15; 78.59; 117.71; 111.67	—
SECONDARY Maximum Peak Isokinetic Leg Strength as Measured by Biodex Pro4 After 4 Weeks of Active Drug	106.79; 79.33; 116.48; 114.75	—
SECONDARY Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry at Week 0.	44.60; 41.43; 49.93; 54.45	—
SECONDARY Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry at Week 4.	46.29; 41.02; 50.61; 54.85	—
SECONDARY Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry at Week 8.	46.22; 40.76; 52.09; 55.10	—
SECONDARY Fat Mass as Measured by Dual Energy X-ray Absorptiometry at Week 0.	32.35; 37.21; 32.72; 32.10	—
SECONDARY Fat Mass as Measured by Dual Energy X-ray Absorptiometry at Week 4.	33.16; 37.12; 32.30; 32.47	—
SECONDARY Fat Mass as Measured by Dual Energy X-ray Absorptiometry at Week 8.	33.60; 37.02; 32.40; 32.79	—
SECONDARY Walking Distance at 100% Effort as Measured by Walking Test After 4 Weeks of Placebo	203.82; 189.79; 198.41; 202.80	—
SECONDARY Walking Distance at 100% Effort as Measured by Walking Test After 4 Weeks of Active Drug	197.01; 178.56; 200.19; 203.46	—
SECONDARY Perceptual Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form Total Score at Week 0	9.66; -7.5; -8; -3.75	—
SECONDARY Perceptual Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form Total Score at Week 4	6.33; -3.33; -6.33; -3.5	—
SECONDARY Perceptual Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form Total Score at Week 8	9.67; 3.25; -9.67; -9.25	—

Summary

This study is funded by the Moody Endowment. In this project, we will investigate the potential effect of skeletal muscle nitric oxide (NO) production on skeletal muscle anabolism, muscle strength, physical function, and body composition in older individuals. Further, we will determine whether augmentation of NO-mediated signaling reduces fatigue and fatigability.

Eligibility Criteria

Inclusion Criteria

Age 50-60 years of age
Ability to sign consent form (score>23 on the 30-item Mini Mental Status examination, MMSE)
Stable body weight for at least three months.

Exclusion Criteria

Physical dependence or frailty (impairment in any of the Activities of Daily Living (ADL), history of falls (>2/year) or significant weight loss in the past year).
Pregnancy
Significant heart, liver, kidney, blood or respiratory disease.
Peripheral vascular disease.
Diabetes mellitus or other untreated endocrine disease.
Active cancer
Use of nitrates.
Recent (within 6 months) treatment with anabolic steroids, or corticosteroids.
Alcohol or drug abuse.
Severe depression (>5 on the 15-item Geriatric Depression Scale, GDS).
Cardiac abnormalities such as cardiac shunt or previously diagnosed pulmonary hypertension.
Systolic blood pressure 150, diastolic blood pressure . This range is smaller than the acceptable range stated in the prescribing information for sildenafil/tadalafil (90/50 and <170/110).

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Data sourced from ClinicalTrials.gov (NCT01661595). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.