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

Completed · Not applicable · Has a placebo group

Conditions studied: Fatigue

In brief

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.

Key facts

Study ID

NCT01661595

Run by

The University of Texas Medical Branch, Galveston

People needed

30

Starts

2012-11-01

Expected to finish

2015-06-01

Last updated by the study team

2018-07-17

Who can join

Age: 50 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 <100 or>150, diastolic blood pressure <60 or 90>. This range is smaller than the acceptable range stated in the prescribing information for sildenafil/tadalafil (90/50 and <170/110).

Where it is running

• University of Texas Medical Branch — Galveston, Texas, United States

Full record on ClinicalTrials.gov

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