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Completed

NCT Number: NCT05395390

COPD Circuit Exercise

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise (Resistance Training

Behavioral

Resistance Training done both at home and on site using either dumbells or keiser pneumatic exercise machines respectively

Primary outcomes

  1. Whole-body protein and amino acid metabolism response to training

    Time frame: up to 8 weeks Exercise Intervention

    Whole-body production rate measured after stable tracer administration

Secondary outcomes

  1. Body Composition using Dual Energy X-Ray Absorptiometry bone density

    Time frame: up to 8 week Exercise Intervention

    Measurement of bone mineral density (g/cm^2)between COPD patients and healthy older adults using DXA

  2. Body Composition using Dual Energy X-Ray Absorptiometry Muscle

    Time frame: up to 8 week Exercise Intervention

    Measurement of muscle mass (kg)

  3. Body Composition using Dual Energy X-Ray Absorptiometry Fat

    Time frame: up to 8 week Exercise Intervention

    Measurement of fat mass (kg)

  4. Bone mineral density by BIA

    Time frame: up to 8 week Exercise Intervention

    Differences in muscle mass (kg), fat mass (kg), and extra- and intracellular fluid (L) between COPD patients and healthy older adults using BIA.

  5. Handgrip strength dynamometry by Handgrip Dynamometer

    Time frame: up to 8 week Exercise Intervention

    Difference and changes in handgrip strength pre and post exercise

  6. 6 minute walk test distance by 6 minute walk test

    Time frame: up to 8 week Exercise Intervention

    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.

  7. Skeletal muscle strength of leg by Kin-Com

    Time frame: up to 8 week Exercise Intervention

    Difference in muscle strength of leg using kin-com machine between pre and post exercise intervention.

  8. C-reactive protein by Blood Analysis

    Time frame: up to 8 week Exercise Intervention

    Differences and changes in the concentration of the inflammatory marker C-reactive protein

  9. Attention and executive functions measured by Trail Making Test (TMT)

    Time frame: up to 8 week Exercise Intervention

    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.

  10. Attention and executive functions measured by Stroop Color-Word Test (SCWT)

    Time frame: up to 8 week Exercise Intervention

    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.

  11. Gut function as reported by "The Gastrointestinal Symptom Rating Scale"

    Time frame: up to 8 week Exercise Intervention

    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.

  12. Physical activity as reported by "Physical Activity Scale for the Elderly

    Time frame: up to 8 week Exercise Intervention

    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.

  13. State of mood as measured by the Hospital Anxiety and Depression Scale (HADS)

    Time frame: up to 8 week Exercise Intervention

    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.

  14. COPD Assessment Test

    Time frame: up to 8 week Exercise Intervention

    Self-administered questionnaire regarding impact of COPD on daily life

  15. 3-day diet diary

    Time frame: up to 8 week Exercise Intervention

    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.

  16. Group differences in learning and memory as measured by Digit Span

    Time frame: up to 8 week Exercise Intervention

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

  17. Group differences in overall cognitive abilities as measured by Montreal Cognitive Assessment (MoCA)

    Time frame: up to 8 week Exercise Intervention

    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.

  18. Group differences in state of mood as measured by the Profile of Mood State (POMS)

    Time frame: up to 8 week Exercise Intervention

    A psychological distress scale to measure mood disturbance in 6 domains - fatigue-inertia, vigor-activity, tension-anxiety, depression-dejection, anger-hostility, and confusion-bewilderment.

  19. Group differences in learning and memory as measured by Controlled Oral Word Association Test (COWAT)

    Time frame: up to 8 week Exercise Intervention

    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.

  20. Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)

    Time frame: up to 8 week Exercise Intervention

    Quality of life concerns related to fatigue will be assessed only in COPD patients with this questionnaire.

  21. Peak Power and Strength by Keiser Resistance Training Equipment

    Time frame: up to 8 week Exercise Intervention

    Changes in Peak Power and Strength measured through testing completed using Keiser Pneumatic Resistance Training Devices

Sponsors and collaborators

Lead sponsor

Texas A&M University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 27, 2022
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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