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Chronic Obstructive Pulmonary Disorder and Acute Exercise

This study is currently recruiting participants.
See Contacts and Locations
Verified February 2017 by Marielle PKJ Engelen, PhD, Texas A&M University
Sponsor:
Information provided by (Responsible Party):
Marielle PKJ Engelen, PhD, Texas A&M University
ClinicalTrials.gov Identifier:
NCT02780219
First received: May 19, 2016
Last updated: February 28, 2017
Last verified: February 2017
  Purpose
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.

Condition Intervention
Pulmonary Disease, Chronic Obstructive Other: stable amino acid infusion Other: acute exercise with amino acid infusion Other: 24-hour post exercise amino acid infusion

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effects of Acute Resistance Exercise on Protein and Amino Acid Metabolism in Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:


Further study details as provided by Marielle PKJ Engelen, PhD, Texas A&M University:

Primary Outcome Measures:
  • Change in net whole-body protein synthesis [ Time Frame: 2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210 and 240 ± 5 minutes ]
    Change in whole-body protein synthesis rate


Secondary Outcome Measures:
  • glutamate related metabolism [ Time Frame: 2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210 and 240 ± 5 minutes ]
  • tryptophan related metabolism [ Time Frame: 2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210 and 240 ± 5 minutes ]
  • arginine related metabolism [ Time Frame: 2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210 and 240 ± 5 minutes ]
  • leucine related metabolism [ Time Frame: 2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210 and 240 ± 5 minutes ]
  • taurine related metabolism [ Time Frame: 2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210 and 240 ± 5 minutes ]
  • Body Composition [ Time Frame: 15 minutes on screening or study day 1 ]
    Body composition as measured by Dual-Energy X-ray Absorptiometry

  • changes in skeletal muscle fatigue [ Time Frame: on study day 1 and change from day 2 and day 3 ]
    kin-com 1-leg test

  • Group differences in state of mood as measured by the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 1 day ]
    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) [ Time Frame: on study day 1 and change from day 2 and day 3 ]
    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 [ Time Frame: on study day 1 and change from day 2 and day 3 ]
    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 [ Time Frame: on study day 1 and change from day 2 and day 3 ]
    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) [ Time Frame: study day 1 ]
    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 [ Time Frame: study day 1 ]
    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 [ Time Frame: study day 1 ]
    The subject is asked to rate various aspects of their appetite as relates to overall health


Estimated Enrollment: 90
Study Start Date: February 2016
Estimated Study Completion Date: February 2019
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Healthy

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

Other: stable amino acid infusion
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
Other: acute exercise with amino acid infusion
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
Other: 24-hour post exercise amino acid infusion
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
Experimental: Chronic Obstructive Pulmonary Disorder

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

Other: stable amino acid infusion
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
Other: acute exercise with amino acid infusion
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
Other: 24-hour post exercise amino acid infusion
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

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.
  Eligibility

Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02780219

Contacts
Contact: Marielle Engelen, PhD 9792202282 mpkj.engelen@ctral.org
Contact: Clayton Cruthirds, MS 7138280116 Cl.cruthirds@ctral.org

Locations
United States, Texas
Texas A&M University-CTRAL Recruiting
College Station, Texas, United States, 77845-4253
Contact: Marielle Engelen, PhD    979-220-2282    mpkj.engelen@ctral.org   
Contact: Clayton Cruthirds, MS    7138280116    Cl.cruthirds@ctral.org   
Sponsors and Collaborators
Texas A&M University
Investigators
Principal Investigator: Marielle Engelen, PhD Texas A&M University
  More Information

Responsible Party: Marielle PKJ Engelen, PhD, PhD, Texas A&M University
ClinicalTrials.gov Identifier: NCT02780219     History of Changes
Other Study ID Numbers: 2015-0768
Study First Received: May 19, 2016
Last Updated: February 28, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive

ClinicalTrials.gov processed this record on September 19, 2017