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
Results First Received: September 25, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Fatigue
Aging
Interventions: Drug: Placebo sildenafil
Drug: Sildenafil

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Males in the age groups of 20-35 and 60-80 were recruited. Subjects were screened and enrolled at the University of Texas Medical Branch in the Institute for Translational Sciences Clinical Research Center (ITS-CRC).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants who failed screening, did not otherwise meet inclusion criteria, or decided not to participate were excluded before being assigned to intervention groups.

Reporting Groups
  Description
Sildenafil Placebo Young Sildenafil placebo: Oral, daily, 1 week.
Sildenafil Young Sildenafil: oral, 25mg, daily for 1 week
Sildenafil Placebo Older Sildenafil placebo: Oral, daily, 1 week.
Sildenafil Older Sildenafil: oral, 25mg, daily for 1 week

Participant Flow:   Overall Study
    Sildenafil Placebo Young     Sildenafil Young     Sildenafil Placebo Older     Sildenafil Older  
STARTED     3     2     3     4  
COMPLETED     3     2     3     3  
NOT COMPLETED     0     0     0     1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Sildenafil Young Sildenafil placebo: Oral, daily, 1 week.
Sildenafil Young Sildenafil: oral, 25mg, daily for 1 week
Placebo Sildenafil Older Sildenafil placebo: Oral, daily, 1 week.
Sildenafil Older Sildenafil: oral, 25mg, daily for 1 week
Total Total of all reporting groups

Baseline Measures
    Placebo Sildenafil Young     Sildenafil Young     Placebo Sildenafil Older     Sildenafil Older     Total  
Number of Participants  
[units: participants]
  3     2     3     4     12  
Age, Customized  
[units: years]
Mean (Standard Deviation)
  25  (6)     29  (4)     63  (5)     74  (4)     51  (23)  
Gender  
[units: participants]
         
Female     0     0     0     0     0  
Male     3     2     3     4     12  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Muscle Fatigue   [ Time Frame: 2 weeks ]

2.  Secondary:   Protein Synthesis   [ Time Frame: 2 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. William Durham
Organization: University of Texas Medical Branch
phone: 4097728702
e-mail: wjdurham@utmb.edu


No publications provided


Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT01059994     History of Changes
Other Study ID Numbers: 09-213
Study First Received: January 28, 2010
Results First Received: September 25, 2015
Last Updated: November 18, 2015
Health Authority: United States: Institutional Review Board