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

NCT01059994 | Completed Results

• 1 other identifier: 09-213
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fatigue; Aging

Keywords

fatigue; aging

Outcome Measures

Primary Outcomes (1)

• Change in Muscle Fatigue After 1 Week of Placebo or Sildenafil

  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).

  baseline to 1 week

Secondary Outcomes (1)

• Protein Synthesis Rate After 1 Week of Sildenafil or Placebo

  1 week

Study Arms (4)

placebo sildenafil young

PLACEBO COMPARATOR

Younger subjects (ages 20-35) were administered placebo sildenafil orally daily for 1 week.

Drug: Placebo sildenafil

sildenafil young

EXPERIMENTAL

Younger subjects (ages 20 -35) were administered sildenafil daily (25 mg/day) orally for 1 week.

Drug: Sildenafil

placebo sildenafil older

PLACEBO COMPARATOR

Older subjects (ages 60-80) were administered placebo sildenafil orally daily for 1 week.

Drug: Placebo sildenafil

sildenafil older

EXPERIMENTAL

Older subjects (ages 60 - 80) were administered sildenafil daily (25 mg/day) orally for 1 week.

Drug: Sildenafil

Interventions

Placebo sildenafil DRUG

Oral, daily, 1 week.

Also known as: Viagra

placebo sildenafil older; placebo sildenafil young

Sildenafil DRUG

oral, 25mg, daily for 1 week

Also known as: Viagra

sildenafil older; sildenafil young

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age 20-35 yrs, and 60-80 yrs.
• \. Ability to sign consent form (score \>23 on the 30-item Mini Mental State Examination, MMSE)
• \. Stable body weight for at least 3 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)
• \. Exercise training (\>2 weekly sessions of moderate to high intensity aerobic or resistance exercise)
• \. 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 a cardiac shunt or previously diagnosed pulmonary hypertension.
• \. Systolic blood pressure \<100 or \>150, diastolic blood pressure \<60 or \>90.

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

Fatigue

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Melinda Sheffield-Moore
• Organization: University of Texas Medical Branch

melmoore@utmb.edu

4097728126

Study Officials

• William Durham, Ph.D.

  University of Texas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2010
• First Posted: February 1, 2010
• Study Start: January 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: February 11, 2019
• Results First Posted: December 23, 2015

Record last verified: 2018-11

Locations

US (1)