Recovery, Fatigability, and Proteomic Response to Aerobic Exercise Training in Healthy Individuals
1 other identifier
interventional
21
1 country
1
Brief Summary
The purpose of this protocol is to investigate the role of expired non-metabolic carbon dioxide in the relationship between fatigability and recovery and the response to aerobic exercise training in healthy individuals. Both fatigability and recovery are profoundly influenced by mitochondrial energetics which can be inhibited by ionic by-product accumulation during exercise. Buffering mechanisms of these fatigue-inducing ions releases non-metabolic carbon dioxide (CO2) that can be measured as expired CO2 (VCO2) during cardiopulmonary exercise testing (CPET), however the role of non-metabolic VCO2 in the relationship between fatigability and recovery has yet to be investigated. Furthermore, this study aims to identify the how the patterns of proteins in healthy individuals respond to aerobic exercise training (e.g. stationary cycling) over approximately one month. The underlying mechanisms of recovery after physical activity, including mechanisms or biological pathways that could be highlighted by analysis of proteins in urine, could add to scientific knowledge regarding physical activity tolerance and potential exercise interventions. This knowledge could eventually assist with designing precise and personalized exercise interventions to improve physical activity performance. The investigators hypothesize that 1) non-metabolic CO2 will be at least moderately associated with the inverse relationship between fatigability and recovery; and 2) highly active adults, compared to sedentary individuals, will exhibit differential proteomic patterns in response to an initial acute bout and subsequent repeated bouts of aerobic exercise.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2018
CompletedFirst Posted
Study publicly available on registry
January 11, 2019
CompletedStudy Start
First participant enrolled
January 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 24, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 24, 2019
CompletedMay 16, 2019
May 1, 2019
3 months
December 18, 2018
May 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Non-metabolic VCO2
Correlate measures of non-metabolic carbon dioxide (as measured by the contribution of total expired non-metabolic VCO2) with the correlative relationship between fatigability (as measured by total time during an endurance CPET and on-kinetics during a constant square-wave CPET) and recovery (as measured by VO2 and VCO2 following maximal and submaximal CPET). Compare changes in measures of non-metabolic carbon dioxide (as measured by the contribution of total expired non-metabolic VCO2) and changes in oxygen consumption (as measured by VO2) pre and post exercise training.
pre and post 5 week (4 training sessions per week, 17 total sessions) aerobic exercise training protocol
Secondary Outcomes (1)
Urinary proteome
This outcome will be assessed at 10 time points per participant: each morning of visits 3,4,7,8,11,12,15,16,19, and 20. Data will be collected during these 5 weeks and at post-testing occurring the week following the end of training.
Study Arms (1)
Healthy
EXPERIMENTALHealthy individuals will participate in two separate days of cardiopulmonary exercise testing (CPET) (separated by a minimum of two, maximum of 7 days apart) prior to starting the aerobic exercise training program (AET). Individuals will then complete a 4-5 week (4x/week x 17 sessions) continuous, high-intensity AET. Each training session will consist of cycling for 3-5 minutes to warm-up, 45 minutes at 70% of heart rate reserve (HRR-determined from pre-training CPET), and 5-10 minutes to cool down. Following the AET, individuals will repeat the two separate days of CPET performed pre-training.
Interventions
Eligibility Criteria
You may qualify if:
- age 18-60
- body mass index \> 19 to \<35 kg/m2
- able to pedal leg cycle ergometer
- able to comprehend and speak English
You may not qualify if:
- diabetes mellitus
- significant pulmonary dysfunction (eg. chronic obstructive lung disease; interstitial lung disease)
- hypertension
- anemia
- stroke
- cancer (other than melanoma)
- cardiac, pulmonary, thyroid, autoimmune, musculoskeletal, neurological, metabolic bone, mitochondrial, hepatic, renal, and/or psychiatric disease
- abnormal blood lipids
- active substance abuse or cognitive impairment
- chronic infection requiring antiviral or antibiotic treatment
- taking any medications that may limit exercise capacity or the ability to adapt to aerobic exercise training
- previously or currently on anticoagulant therapy or therapeutic hormone replacement/supplementation (excluding birth control)
- pregnant
- smoking
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
George Mason University
Fairfax, Virginia, 22030, United States
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BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew A Guccione, PT, PhD, DPT
George Mason University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2018
First Posted
January 11, 2019
Study Start
January 22, 2019
Primary Completion
April 24, 2019
Study Completion
April 24, 2019
Last Updated
May 16, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share