OSANCT05395390
COPD Circuit Exercise
A study testing Exercise (Resistance Training in people with OSA and Covid19, run by Texas A&M University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 30 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- OSA, Covid19, Residual Symptoms of COVID 19
- What is being tested?
- Exercise (Resistance Training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2021to 7 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- ● 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.
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- OSA, Covid19, Residual Symptoms of COVID 19, COPD
- Being tested
- Exercise (Resistance Training
- Medical subject headings
- COVID-19, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise (Resistance TrainingBehavioural
Resistance Training done both at home and on site using either dumbells or keiser pneumatic exercise machines respectively
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole-body protein and amino acid metabolism response to training
Whole-body production rate measured after stable tracer administration
Measured: up to 8 weeks Exercise Intervention
Secondary outcomes (21)
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
Measured: up to 8 week Exercise Intervention
Body Composition using Dual Energy X-Ray Absorptiometry Muscle
Measurement of muscle mass (kg)
Measured: up to 8 week Exercise Intervention
Body Composition using Dual Energy X-Ray Absorptiometry Fat
Measurement of fat mass (kg)
Measured: 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.
Measured: up to 8 week Exercise Intervention
Handgrip strength dynamometry by Handgrip Dynamometer
Difference and changes in handgrip strength pre and post exercise
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 8 week Exercise Intervention
COPD Assessment Test
Self-administered questionnaire regarding impact of COPD on daily life
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: up to 8 week Exercise Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start2 Feb 2021
- Primary completion7 Aug 2023
- Study completion7 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OSAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marielle PKJ Engelen, PhD, Texas A&M University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05395390
- Sponsor's protocol ID
- 2019-0149
- Status last verified
- Sep 2025
- First submitted
- 10 Dec 2021
- Last updated
- 30 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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).
Publications
Huttl VN, Deutz N, Wierzchowska-McNew RA, Ruebush LE, Engelen M. Whole-body and intracellular arginine metabolism in hypertension: role of disease severity and sex. Am J Hypertens. 2026 May 18:hpag047. doi: 10.1093/ajh/hpag047. Online ahead of print.
PubMed 42149813Yu AK, Deutz NEP, Perez CN, DeWandel S, Ruebush LE, Engelen MPKJ. The acute effects of alpha-lactalbumin intake on tryptophan metabolites and mood in older adults with Mild Cognitive Impairment. Nutr Neurosci. 2026 Feb;29(2):180-194. doi: 10.1080/1028415X.2025.2554359. Epub 2025 Sep 14.
PubMed 40946231
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circuit-Exercise Training on Subjects With and Without Chronic Respiratory Disease
- ClinicalTrials.gov ID
- NCT05395390
- Acronym / sponsor ID
- 2019-0149
- Conditions
- OSA, Covid19, Residual Symptoms of COVID 19, COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- 7 Aug 2023 (actual)
- Study completion
- 7 Aug 2023 (actual)
- First posted
- 27 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Ability to walk, sit down and stand up independently
- -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.
Key exclusion criteria (10 listed)
- Unable to exercise due to physical limitations (i.e. neuromuscular and/or orthopedic disorders)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise (Resistance TrainingResistance Training done both at home and on site using either dumbells or keiser pneumatic exercise machines respectively | Behavioural | – |
Primary outcome
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
21 secondary outcomes
Body Composition using Dual Energy X-Ray Absorptiometry bone density
Time frame: up to 8 week Exercise Intervention
Body Composition using Dual Energy X-Ray Absorptiometry Muscle
Time frame: up to 8 week Exercise Intervention
Body Composition using Dual Energy X-Ray Absorptiometry Fat
Time frame: up to 8 week Exercise Intervention
Bone mineral density by BIA
Time frame: up to 8 week Exercise Intervention
Handgrip strength dynamometry by Handgrip Dynamometer
Time frame: up to 8 week Exercise Intervention
6 minute walk test distance by 6 minute walk test
Time frame: up to 8 week Exercise Intervention
Skeletal muscle strength of leg by Kin-Com
Time frame: up to 8 week Exercise Intervention
C-reactive protein by Blood Analysis
Time frame: up to 8 week Exercise Intervention
Attention and executive functions measured by Trail Making Test (TMT)
Time frame: up to 8 week Exercise Intervention
Attention and executive functions measured by Stroop Color-Word Test (SCWT)
Time frame: up to 8 week Exercise Intervention
Gut function as reported by "The Gastrointestinal Symptom Rating Scale"
Time frame: up to 8 week Exercise Intervention
Physical activity as reported by "Physical Activity Scale for the Elderly
Time frame: up to 8 week Exercise Intervention
State of mood as measured by the Hospital Anxiety and Depression Scale (HADS)
Time frame: up to 8 week Exercise Intervention
COPD Assessment Test
Time frame: up to 8 week Exercise Intervention
3-day diet diary
Time frame: up to 8 week Exercise Intervention
Group differences in learning and memory as measured by Digit Span
Time frame: up to 8 week Exercise Intervention
Group differences in overall cognitive abilities as measured by Montreal Cognitive Assessment (MoCA)
Time frame: up to 8 week Exercise Intervention
Group differences in state of mood as measured by the Profile of Mood State (POMS)
Time frame: up to 8 week Exercise Intervention
Group differences in learning and memory as measured by Controlled Oral Word Association Test (COWAT)
Time frame: up to 8 week Exercise Intervention
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
Time frame: up to 8 week Exercise Intervention
Peak Power and Strength by Keiser Resistance Training Equipment
Time frame: up to 8 week Exercise Intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Derived from this study: PubMed 42149813Huttl VN, Deutz N, Wierzchowska-McNew RA, Ruebush LE, Engelen M. Whole-body and intracellular arginine metabolism in hypertension: role of disease severity and sex. Am J Hypertens. 2026 May 18:hpag047. doi: 10.1093/ajh/hpag047. Online ahead of print.
- Derived from this study: PubMed 40946231Yu AK, Deutz NEP, Perez CN, DeWandel S, Ruebush LE, Engelen MPKJ. The acute effects of alpha-lactalbumin intake on tryptophan metabolites and mood in older adults with Mild Cognitive Impairment. Nutr Neurosci. 2026 Feb;29(2):180-194. doi: 10.1080/1028415X.2025.2554359. Epub 2025 Sep 14.
- Individual participant dataSharing planned: Undecided. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise (Resistance Training in people with OSA and Covid19, run by Texas A&M University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole-body protein and amino acid metabolism response to training (time frame: up to 8 weeks Exercise Intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05395390, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.