COPD Circuit Exercise

Circuit-Exercise Training on Subjects With and Without Chronic Respiratory Disease

This study is being done to understand body's response to hybrid home-based and on-site rehabilitation program utilizing individually tailored exercises throughout a total of 18 sessions with 12 of them occurring onsite, in people with and without chronic respiratory diseases, such as Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA) and in individuals recovered from COVID-19. Exercise training programs vary widely for people with COPD, OSA, and during prolonged recovery from COVID infection. This study will help identify if this program is helpful to address muscle loss and fatigue specifically in populations with and without chronic respiratory diseases.

Study Overview

• Status: Recruiting
• Conditions: Covid19; OSA; COPD; Residual Symptoms of COVID 19
• Intervention / Treatment: Behavioral: Exercise (Resistance Training

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sofie deWande, MS; Phone Number: 979-422-1789; Email: research@ctral.org

Study Locations

• United States
  • Texas
    • College Station, Texas, United States, 77843
      • Recruiting
      • Texas A&M University
      • Principal Investigator: Marielle Engelen, Ph.D.
      • Principal Investigator: Nicolaas E Deutz, Ph.D.
      • Contact: Marielle P Engelen, Ph.D.; Phone Number: 979-220-2282; Email: mpkj.engelen@ctral.org
      • Contact: Sofie deWandel; Phone Number: 9794221789; Email: research@ctral.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Ability to walk, sit down and stand up independently

  • Age 30 - 85 years
  • Ability to lay in supine or elevated position for up to 3 hours
  • Diagnosis of moderate to very severe chronic airflow limitation and compliant to the following criteria: FEV1 < 70% of reference FEV1

-or- Obstructive Sleep Apnea (OSA)

-or- 2 weeks post-recovered* from laboratory confirmed case of COVID

● Willingness and ability to comply with the protocol

*Recovered is defined according to Brazos County Health District as someone who has been fever-free for 24 hours without fever-reducing medications, and it has been 10 days after onset of symptoms.

Inclusion criteria control 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 30 - 85 years
• Ability to lay in supine or elevated position for up to 3 hours
• No diagnosis of chronic lung disease
• Willingness and ability to comply with the protocol

Exclusion Criteria:

• Unable to exercise due to physical limitations (i.e. neuromuscular and/or orthopedic disorders)

  • Established diagnosis of malignancy
  • Presence of acute illness or metabolically unstable chronic illness
  • Presence of fever within the last 3 days.
  • Expected to have surgery within 1 month of screening or during exercise training
  • Any other condition according to the PI or research staff that was found during the screening visit, that would interfere with the study or safety of the patient.
  • Previous injury that could interfere with participation in resistance exercise protocol.
  • 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. When during the period from enrollment to the test day any condition causing the subject to not meet inclusion criteria or to meet exclusion criteria, the subject will be excluded from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Whole-body protein and amino acid metabolism response to training	Whole-body production rate measured after stable tracer administration	up to 8 weeks Exercise Intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Composition using Dual Energy X-Ray Absorptiometry bone density	Measurement of bone mineral density (g/cm^2)between COPD patients and healthy older adults using DXA	up to 8 week Exercise Intervention
Body Composition using Dual Energy X-Ray Absorptiometry Muscle	Measurement of muscle mass (kg)	up to 8 week Exercise Intervention
Body Composition using Dual Energy X-Ray Absorptiometry Fat	Measurement of fat mass (kg)	up to 8 week Exercise Intervention
Bone mineral density by BIA	Differences in muscle mass (kg), fat mass (kg), and extra- and intracellular fluid (L) between COPD patients and healthy older adults using BIA.	up to 8 week Exercise Intervention
Handgrip strength dynamometry by Handgrip Dynamometer	Difference and changes in handgrip strength pre and post exercise	up to 8 week Exercise Intervention
6 minute walk test distance by 6 minute walk test	With this sub-maximal exercise test, aerobic capacity and endurance will be compared between COPD patients and healthy older adults. The outcome is the distance covered over a time of 6 minutes.	up to 8 week Exercise Intervention
Skeletal muscle strength of leg by Kin-Com	Difference in muscle strength of leg using kin-com machine between pre and post exercise intervention.	up to 8 week Exercise Intervention
C-reactive protein by Blood Analysis	Differences and changes in the concentration of the inflammatory marker C-reactive protein	up to 8 week Exercise Intervention
Attention and executive functions measured by Trail Making Test (TMT)	In Part A, the examinee is instructed to connect a set of 25 circles with numbers as quickly as possible while maintaining accuracy. In Part B, the examinee is instructed to connect a set of 25 circles, alternating between numbers and letters, as quickly as possible while maintaining accuracy. Measures attentional resources and is a measure of the frontal lobe "executive" functions of visual search, set-switching and mental flexibility. The total time in seconds will be recorded for each measure.	up to 8 week Exercise Intervention
Attention and executive functions 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.	up to 8 week Exercise Intervention
Gut function as reported by "The Gastrointestinal Symptom Rating Scale"	Self-administered questionnaire regarding gut function and associated symptoms. It is composed of 15 items (7-Point Likert Scale) assessing Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation. Scores range from 15 to 105 with a higher score indicating more discomfort.	up to 8 week Exercise Intervention
Physical activity as reported by "Physical Activity Scale for the Elderly	Self-administered 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.	up to 8 week Exercise Intervention
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.	up to 8 week Exercise Intervention
COPD Assessment Test	Self-administered questionnaire regarding impact of COPD on daily life	up to 8 week Exercise Intervention
3-day diet diary	The subject is asked to note in detail all the food and drinks consumed during 3 days (2 week days and 1 weekend day) in the week prior to each test day.	up to 8 week Exercise Intervention
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.	up to 8 week Exercise Intervention
Group differences in overall cognitive abilities as measured by Montreal Cognitive Assessment (MoCA)	Assesses several cognitive domains and is used for the screening of mild cognitive impairment. Total scores range from 0-30 with lower scores indicating decreased functioning.	up to 8 week Exercise Intervention
Group differences in state of mood as measured by the Profile of Mood State (POMS)	A psychological distress scale to measure mood disturbance in 6 domains - fatigue-inertia, vigor-activity, tension-anxiety, depression-dejection, anger-hostility, and confusion-bewilderment.	up to 8 week Exercise Intervention
Group differences in learning and memory as measured by Controlled Oral Word Association Test (COWAT)	The examinee is required to say as many words as they can think of in one minute that begin with a given letter of the alphabet. The task contains three trials. Measures phonemic verbal fluency. The raw score (total and mean words recorded across the three trials) will be reported.	up to 8 week Exercise Intervention
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)	Quality of life concerns related to fatigue will be assessed only in COPD patients with this questionnaire.	up to 8 week Exercise Intervention
Peak Power and Strength by Keiser Resistance Training Equipment	Changes in Peak Power and Strength measured through testing completed using Keiser Pneumatic Resistance Training Devices	up to 8 week Exercise Intervention

Collaborators and Investigators

• Sponsor: Texas A&M University

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2021
• Primary Completion (Anticipated): May 5, 2023
• Study Completion (Anticipated): May 5, 2024

Study Registration Dates

• First Submitted: December 10, 2021
• First Submitted That Met QC Criteria: May 24, 2022
• First Posted (Actual): May 27, 2022

Study Record Updates

• Last Update Posted (Actual): May 27, 2022
• Last Update Submitted That Met QC Criteria: May 24, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 2019-0149 (Other Identifier: M D Anderson Cancer Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data may be shared upon request for up to 6 years beyond completion of the trial based on methods/proposal approved by both parties' institutional review committees. Individual participant data that underlie the results of the trial may be shared after de-identification (text, tables, figures, and appendices). Additional documents available per request include: study protocol, statistical analysis plan, and informed consent. Requests should be directed to Dr. Marielle Engelen (mpkj.engelen@ctral.org).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No