N/A
Completed N=12
Role of Skeletal Muscle Nitric Oxide Production in Age-related Fatigue and Fatigability
Source: ClinicalTrials.gov NCT01059994 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcomePrimary: Change in Muscle Fatigue After 1 Week of Placebo or Sildenafil — 107; 115; 54; 158 percent change of successful repetitions — p=0.02
Summary
This is a pilot study funded by the National Institutes of Health. In this project, we will investigate the potential effect of skeletal muscle nitric oxide (NO) production on muscle strength and physical function in older individuals. We propose to test a new method that may enable simultaneous determination of both vascular and skeletal muscle NO production for the first time in humans. Further, we will determine whether augmentation of NO-mediated responses, by administration of sildenafil citrate (Viagra), reduces fatigue and fatigability in older individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Muscle Fatigue After 1 Week of Placebo or Sildenafil |
107; 115; 54; 158 | 0.02 sig |
| SECONDARY Protein Synthesis Rate After 1 Week of Sildenafil or Placebo |
0.06; 0.11; 0.04; 0.10 | 0.004 sig |
Eligibility Criteria
Inclusion Criteria
- 1. Age 20-35 yrs, and 60-80 yrs.
- 2. Ability to sign consent form (score >23 on the 30-item Mini Mental State Examination, MMSE)
- 3. Stable body weight for at least 3 months
Exclusion Criteria
- 1. 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)
- 2. Exercise training (>2 weekly sessions of moderate to high intensity aerobic or resistance exercise)
- 3. Pregnancy
- 4. Significant heart, liver, kidney, blood or respiratory disease
- 5. Peripheral vascular disease
- 6. Diabetes mellitus or other untreated endocrine disease
- 7. Active cancer
- 8. Use of nitrates
- 9. Recent (within 6 months) treatment with anabolic steroids, or corticosteroids.
- 10. Alcohol or drug abuse
- 11. Severe depression (>5 on the 15-item Geriatric Depression Scale, GDS)
- 12. Cardiac abnormalities such as a cardiac shunt or previously diagnosed pulmonary hypertension.
- 13. Systolic blood pressure 150, diastolic blood pressure 90.
Data sourced from ClinicalTrials.gov (NCT01059994). 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. Informational only — not medical advice.