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Chronic Obstructive Pulmonary Disorder and Acute Exercise

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

stable amino acid infusion

acute exercise with amino acid infusion

24-hour post exercise amino acid infusion

About this trial

This is an interventional supportive care trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria COPD subjects:

Ability to walk, sit down and stand up independently
Age 45 years or older
Ability to lie in supine or elevated position for 4 hours
Diagnosis of moderate to very severe chronic airflow limitation and compliant to the following criteria: FEV1 < 70% of reference FEV1
Clinically stable condition and not suffering from a respiratory tract infection or exacerbation of their disease (defined as a combination of increased cough, sputum purulence, shortness of breath, systemic symptoms such as fever, and a decrease in FEV1 > 10% compared with values when clinically stable in the preceding year) at least 4 weeks prior to the first test day
Shortness of breath on exertion
Willingness and ability to comply with the protocol

Inclusion criteria healthy subjects:

Healthy male or female according to the investigator's or appointed staff's judgment
Ability to walk, sit down and stand up independently
Age 45 years or older
Ability to lay in supine or elevated position for 4 hours
No diagnosis of COPD
Willingness and ability to comply with the protocol

Exclusion Criteria all subjects:

Any condition that may interfere with the definition 'healthy subject' according to the investigator's judgment (healthy subjects only)
Established diagnosis of malignancy
History of untreated metabolic diseases including hepatic or renal disorder
Presence of acute illness or metabolically unstable chronic illness
Presence of fever within the last 3 days
Body mass index >40 kg/m2 (healthy subjects only)
Any other condition according to the PI or nurse that was found during the screening visit, that would interfere with the study or safety of the patient
Use of protein or amino acid containing nutritional supplements within 5 days of first study day
Previous injury that could interfere with participation in resistance exercise protocol
Use of short course of oral corticosteroids within 4 weeks preceding first study day
Failure to give informed consent or Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
(Possible) pregnancy
Already enrolled in another clinical trial and that clinical trial interferes with participating in this study

Sites / Locations

Texas A&M University-CTRALRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Healthy

Chronic Obstructive Pulmonary Disorder

Arm Description

screening visit: body weight and composition by DXA, height, and vital signs will be assessed. study day(s): may include combinations of stable isotope infusions with blood draws, acute exercise, cognition testing

Outcomes

Primary Outcome Measures

Change in net whole-body protein synthesis

Change in whole-body protein synthesis rate

Secondary Outcome Measures

glutamate related metabolism

tryptophan related metabolism

arginine related metabolism

leucine related metabolism

taurine related metabolism

Body Composition

Body composition as measured by Dual-Energy X-ray Absorptiometry

changes in skeletal muscle fatigue

kin-com 1-leg test

Group differences in state of mood as measured by the Hospital Anxiety and Depression Scale (HADS)

a fourteen item self-assessment scale. Seven of the items related to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression.

Group differences in attention and executive functions as measured by Stroop Color-Word Test (SCWT)

a word page with words printed in black ink, a color page with blocks printed in color, and a color-word page where the color and the word do not match. The examinee reads the words or names the ink colors as quickly as possible within a time limit. Measures selective attention and inhibitory control. The total time in seconds was reported for each trial.

Group differences in learning and memory as measured by Digit Span

recall of numbers in the same order (Digit Forward) and in reverse order (Digit Backward). Measures auditory attention and verbal working memory.

Group differences in attention and executive functions as measured by Digit Symbol Modalities Test

Using a legend with nine symbols that correspond to nine different numbers, the examinee is asked to fill in as many blank squares as possible by copying the corresponding number in each box, indexed by a symbol within a 90 sec time limit.

Group differences in activity as measured by Physical Activity Scale for the Elderly (PASE)

This questionnaire is intended for use in an elderly population and focuses on 3 types of activities: leisure time activities, household activities and work-related activities.

24 hour diet recall

The subject is asked to recall in detail all the food and drink consumed during the 24 hours prior to the test day.

appetite questionnaire

The subject is asked to rate various aspects of their appetite as relates to overall health

Full Information

NCT ID

NCT02780219

First Posted

May 19, 2016

Last Updated

April 10, 2019

Sponsor

Texas A&M University

1. Study Identification

Unique Protocol Identification Number

NCT02780219

Brief Title

Chronic Obstructive Pulmonary Disorder and Acute Exercise

Official Title

The Effects of Acute Resistance Exercise on Protein and Amino Acid Metabolism in Chronic Obstructive Pulmonary Disease

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Unknown status

Study Start Date

February 2016 (undefined)

Primary Completion Date

February 2020 (Anticipated)

Study Completion Date

February 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Texas A&M University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

For this study a resistance bout will be performed in order to promote the robust response of protein synthesis. Type II muscle fibers often exhibit more atrophy than type I fibers in COPD subjects therefore specifically targeting them in an exercise protocol could have more beneficial outcome for these individuals.

Detailed Description

In this study, the following hypothesis will be tested: A bout of resistance exercise will affect the acute and 24h response in whole-body protein and amino acid metabolism and cognitive function as compared to baseline values in COPD patients and healthy subjects. To do this, subjects will complete a baseline visit in which they receive stable amino acid tracers. The next day they will complete a one-time resistance exercise with an immediate measurement of the amino acid tracers, and return 24 hours after exercise to repeat amino acid tracer measurements. This project will provide important clinical information on the whole body protein and amino acid metabolic response to acute resistance exercise in elderly subjects with COPD, as well as, the exercise induced changes in physical and cognitive function, and absolute muscular strength capacity in this population. In this way, this study will provide preliminary data for the development of standardized, repeatable resistance exercise protocols that will stop the process of ongoing muscle loss and improve metabolism and function in COPD subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Disease, Chronic Obstructive

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Healthy

Arm Type

Experimental

Arm Description

Arm Title

Chronic Obstructive Pulmonary Disorder

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

stable amino acid infusion

Intervention Description

stable isotopes Such as L-[ring-13C6]-Phenylalanine, L-[ring-D4]Tyrosine, L-[Methyl-D3]Tau-Methylhistidine, trans-[2,5,5-D3]4-Hydroxy-L-proline, L-[Guanido-15N2]-Arginine, L-[4,4,5,5-D4-5-13C]Citruline, L-13C5 -Ornithine, L-15N2-Glutamine, L-[1,2-13C2]Glutamic Acid, 1-13C-Glycine, L-15N3-Histidine, L-13C6-Leucine, L-[methyl-D3]Methionine, α-1-13C-ketoisocaproic acid, L-1-13C-Methionine, DL-[3,3,4,4-D4]Homocysteine, L-[1,2-13C2]Taurine, L-(Indole-D5)Tryptophan, 13C-Urea, L-1-13C-Isoleucine, L-13C5-Valine, α-[Dimethyl-13C2]ketoisovaleric acid, 2-keto-3-methyl-13C6-pentanoate, 3-hydroxy-[3,4-methyl-13C3]isovaleric acid, 13C3-glycerol is given IV simultaneously

Intervention Type

Other

Intervention Name(s)

acute exercise with amino acid infusion

Intervention Description

resistance exercise of each limb (i.e., leg (right/left); arm (right/left) on an isokinetic exercise machine allowing control of velocity, force, etc. with stable isotopes such as L-[ring-13C6]-Phenylalanine, L-[ring-D4]Tyrosine, L-[Methyl-D3]Tau-Methylhistidine, trans-[2,5,5-D3]4-Hydroxy-L-proline, L-[Guanido-15N2]-Arginine, L-[4,4,5,5-D4-5-13C]Citruline, L-13C5 -Ornithine, L-15N2-Glutamine, L-[1,2-13C2]Glutamic Acid, 1-13C-Glycine, L-15N3-Histidine, L-13C6-Leucine, L-[methyl-D3]Methionine, α-1-13C-ketoisocaproic acid, L-1-13C-Methionine, DL-[3,3,4,4-D4]Homocysteine, L-[1,2-13C2]Taurine, L-(Indole-D5)Tryptophan, 13C-Urea, L-1-13C-Isoleucine, L-13C5-Valine, α-[Dimethyl-13C2]ketoisovaleric acid, 2-keto-3-methyl-13C6-pentanoate, 3-hydroxy-[3,4-methyl-13C3]isovaleric acid, 13C3-glycerol is given IV simultaneously

Intervention Type

Other

Intervention Name(s)

24-hour post exercise amino acid infusion

Intervention Description

stable isotopes such as L-[ring-13C6]-Phenylalanine, L-[ring-D4]Tyrosine, L-[Methyl-D3]Tau-Methylhistidine, trans-[2,5,5-D3]4-Hydroxy-L-proline, L-[Guanido-15N2]-Arginine, L-[4,4,5,5-D4-5-13C]Citruline, L-13C5 -Ornithine, L-15N2-Glutamine, L-[1,2-13C2]Glutamic Acid, 1-13C-Glycine, L-15N3-Histidine, L-13C6-Leucine, L-[methyl-D3]Methionine, α-1-13C-ketoisocaproic acid, L-1-13C-Methionine, DL-[3,3,4,4-D4]Homocysteine, L-[1,2-13C2]Taurine, L-(Indole-D5)Tryptophan, 13C-Urea, L-1-13C-Isoleucine, L-13C5-Valine, α-[Dimethyl-13C2]ketoisovaleric acid, 2-keto-3-methyl-13C6-pentanoate, 3-hydroxy-[3,4-methyl-13C3]isovaleric acid, 13C3-glycerol is given IV simultaneously

Primary Outcome Measure Information:

Title

Change in net whole-body protein synthesis

Description

Change in whole-body protein synthesis rate

Time Frame