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Clinical Trials/NCT05484661
NCT05484661
Completed
Not Applicable

Mechanisms to Reduce Mental and Physical Fatigue Following Exercise Training in Older Adults

The University of Texas Health Science Center at San Antonio1 site in 1 country20 target enrollmentDecember 22, 2022
ConditionsFatigueAging

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fatigue
Sponsor
The University of Texas Health Science Center at San Antonio
Enrollment
20
Locations
1
Primary Endpoint
Fatigue
Status
Completed
Last Updated
last year

Overview

Brief Summary

Fatigue is a strong predictor of negative health outcomes in older adults. The research in this study will compared the effects of 8-weeks of branched chain amino acids (BCAAs: dietary supplements commonly taken to improve muscle growth and exercise performance) added to exercise on fatigue compared to exercise with a placebo (an inactive, harmless substance). BCAAs could have an impact on improving fatigue common in older adults, especially when exercising.

Detailed Description

Thirty participants will be asked to participate in this research study. They will be randomized (like a flip of a coin) to exercise + a placebo or exercise + BCAAs for 8 weeks. We would like to examine the effects of the 8-week exercise + dietary supplement program on body composition (fat and muscle), physical activity habits, fatigue, and physical performance (such as walking and strength). We would also like to assess whether these outcomes are controlled by changes in markers (kynurenine metabolites) in the skeletal muscle and blood.

Registry
clinicaltrials.gov
Start Date
December 22, 2022
End Date
November 30, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Monica Serra

Associate Professor

The University of Texas Health Science Center at San Antonio

Eligibility Criteria

Inclusion Criteria

  • Fatigue (participants reporting ≥3 on a 1-10 scale)
  • Lack of menses for at least one year for women
  • BMI 20-50 kg/m2
  • Untrained with regard to structured exercise training (is not currently training more than 2x/week)

Exclusion Criteria

  • Taking an anticoagulant medication that is unable to be discontinued before biopsies
  • Allergic to lidocaine
  • Neurologic, musculoskeletal, or other condition that limits subject's ability to complete study physical assessments or training
  • Hepatic (LFTs \>2.5xWNL), renal (eGFR\<45), , and uncontrolled psychiatric disease
  • Cognitive impairment
  • Uncontrolled depression
  • Any disease or condition considered to be exclusionary based on the clinical opinion and discretion of the principal investigator

Outcomes

Primary Outcomes

Fatigue

Time Frame: change from baseline to 8 weeks

Participants will complete the Fatigue Assessment Scale questionnaire (Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest)

Study Sites (1)

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