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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier:
NCT01059994
First received: January 28, 2010
Last updated: November 18, 2015
Last verified: November 2015

January 28, 2010
November 18, 2015
January 2010
July 2013   (final data collection date for primary outcome measure)
Muscle Fatigue [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
successful isokinetic knee extension repetitions, % baseline day repetitions
Not Provided
Complete list of historical versions of study NCT01059994 on ClinicalTrials.gov Archive Site
Protein Synthesis [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Skeletal muscle protein synthesis, measured as the fractional synthesis rate (the percent of the total synthesized per unit time)
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Role of Skeletal Muscle Nitric Oxide Production in Age-related Fatigue and Fatigability
Role of Skeletal Muscle Nitric Oxide Production in Age-related Fatigue and Fatigability
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.
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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Fatigue
  • Aging
  • Drug: Placebo sildenafil
    Oral, daily, 1 week.
    Other Name: Viagra
  • Drug: Sildenafil
    oral, 25mg, daily for 1 week
    Other Name: Viagra
  • Placebo Comparator: placebo sildenafil young
    Intervention: Drug: Placebo sildenafil
  • Experimental: sildenafil young
    Intervention: Drug: Sildenafil
  • Placebo Comparator: placebo sildenafil older
    Intervention: Drug: Placebo sildenafil
  • Experimental: sildenafil older
    Intervention: Drug: Sildenafil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
July 2013
July 2013   (final data collection date for primary outcome measure)

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 <100 or >150, diastolic blood pressure <60 or >90.
Male
20 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01059994
09-213
No
Not Provided
Not Provided
The University of Texas Medical Branch, Galveston
The University of Texas Medical Branch, Galveston
Not Provided
Principal Investigator: William Durham, Ph.D. University of Texas
The University of Texas Medical Branch, Galveston
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP