CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 59 enrolled
Drug / intervention
TDAP +5 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02261961
NCT02261961N/ACompleted

Immune Function and Muscle Adaptations to Resistance Exercise in Older Adults

VA Office of Research and Development·interventional·Posted Oct 10, 2014·Updated Sep 28, 2021

In Brief

A clinical study evaluating TDAP, Acute Resistance Exercise, and 4 other interventions for Sarcopenia and 2 related conditions. Completed, enrolled 59 participants across 1 site.

Detailed Summary

The loss of muscle mass and strength due to aging leads to serious health problems for older adults. Muscle health can be improved by exercise training, but some people improve their strength substantially, whereas others improve little. The reason for this variation is unknown. This study will investigate whether function of the immune system influences how well people respond to exercise. Older Veterans who participate will have their muscle size, strength, and function measured periodically for almost a year. Participants will drink a nutritional supplement or placebo daily and complete a 36 session strength training program. Participants will be vaccinated for tetanus and donate small amounts of blood and muscle tissue during the study so that immune function can be compared to muscle outcomes during training and during a long-term follow-up. The study results should increase the investigators' understanding of the negative effects of aging on muscle and will possibly lead to better strategies for muscle maintenance and rehabilitation for older adults.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 10, 2014
Enrollment StartJul 23, 2014
Primary CompletionDec 31, 2018
Study CompletionSep 30, 2019
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 11.7 years ago

Interventions

TDAPbiological

Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo

Acute Resistance Exerciseother

Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle

Resistance Exercise Trainingother

Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.

Post-training Follow-upother

Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.

Nutritional Supplement (Muscle Armor)dietary

Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.

Placebo (Kool-Aid)dietary

Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.