Back to resultsCOPD Circuit Exercise
Primary Purpose
OSA, Covid19, Residual Symptoms of COVID 19
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise (Resistance Training
Sponsored by
About this trial
This is an interventional treatment trial for OSA
Eligibility Criteria
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.
Sites / Locations
- Texas A&M UniversityRecruiting
Outcomes
Primary Outcome Measures
Whole-body protein and amino acid metabolism response to training
Whole-body production rate measured after stable tracer administration
Secondary Outcome Measures
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
Body Composition using Dual Energy X-Ray Absorptiometry Muscle
Measurement of muscle mass (kg)
Body Composition using Dual Energy X-Ray Absorptiometry Fat
Measurement of fat mass (kg)
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.
Handgrip strength dynamometry by Handgrip Dynamometer
Difference and changes in handgrip strength pre and post exercise
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.
Skeletal muscle strength of leg by Kin-Com
Difference in muscle strength of leg using kin-com machine between pre and post exercise intervention.
C-reactive protein by Blood Analysis
Differences and changes in the concentration of the inflammatory marker C-reactive protein
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.
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.
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.
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.
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.
COPD Assessment Test
Self-administered questionnaire regarding impact of COPD on daily life
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.
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 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.
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.
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.
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.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05395390
Brief Title
COPD Circuit Exercise
Official Title
Circuit-Exercise Training on Subjects With and Without Chronic Respiratory Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2021 (Actual)
Primary Completion Date
May 5, 2023 (Anticipated)
Study Completion Date
May 5, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas A&M University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
OSA, Covid19, Residual Symptoms of COVID 19, COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Exercise (Resistance Training
Intervention Description
Resistance Training done both at home and on site using either dumbells or keiser pneumatic exercise machines respectively
Primary Outcome Measure Information:
Title
Whole-body protein and amino acid metabolism response to training
Description
Whole-body production rate measured after stable tracer administration
Time Frame
up to 8 weeks Exercise Intervention
Secondary Outcome Measure Information:
Title
Body Composition using Dual Energy X-Ray Absorptiometry bone density
Description
Measurement of bone mineral density (g/cm^2)between COPD patients and healthy older adults using DXA
Time Frame
up to 8 week Exercise Intervention
Title
Body Composition using Dual Energy X-Ray Absorptiometry Muscle
Description
Measurement of muscle mass (kg)
Time Frame
up to 8 week Exercise Intervention
Title
Body Composition using Dual Energy X-Ray Absorptiometry Fat
Description
Measurement of fat mass (kg)
Time Frame
up to 8 week Exercise Intervention
Title
Bone mineral density by BIA
Description
Differences in muscle mass (kg), fat mass (kg), and extra- and intracellular fluid (L) between COPD patients and healthy older adults using BIA.
Time Frame
up to 8 week Exercise Intervention
Title
Handgrip strength dynamometry by Handgrip Dynamometer
Description
Difference and changes in handgrip strength pre and post exercise
Time Frame
up to 8 week Exercise Intervention
Title
6 minute walk test distance by 6 minute walk test
Description
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.
Time Frame
up to 8 week Exercise Intervention
Title
Skeletal muscle strength of leg by Kin-Com
Description
Difference in muscle strength of leg using kin-com machine between pre and post exercise intervention.
Time Frame
up to 8 week Exercise Intervention
Title
C-reactive protein by Blood Analysis
Description
Differences and changes in the concentration of the inflammatory marker C-reactive protein
Time Frame
up to 8 week Exercise Intervention
Title
Attention and executive functions measured by Trail Making Test (TMT)
Description
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.
Time Frame
up to 8 week Exercise Intervention
Title
Attention and executive functions measured by Stroop Color-Word Test (SCWT)
Description
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.
Time Frame
up to 8 week Exercise Intervention
Title
Gut function as reported by "The Gastrointestinal Symptom Rating Scale"
Description
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.
Time Frame
up to 8 week Exercise Intervention
Title
Physical activity as reported by "Physical Activity Scale for the Elderly
Description
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.
Time Frame
up to 8 week Exercise Intervention
Title
State of mood as measured by the Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
up to 8 week Exercise Intervention
Title
COPD Assessment Test
Description
Self-administered questionnaire regarding impact of COPD on daily life
Time Frame
up to 8 week Exercise Intervention
Title
3-day diet diary
Description
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.
Time Frame
up to 8 week Exercise Intervention
Title
Group differences in learning and memory as measured by Digit Span
Description
Recall of numbers in the same order (Digit Forward) and in reverse order (Digit Backward). Measures auditory attention and verbal working memory.
Time Frame
up to 8 week Exercise Intervention
Title
Group differences in overall cognitive abilities as measured by Montreal Cognitive Assessment (MoCA)
Description
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.
Time Frame
up to 8 week Exercise Intervention
Title
Group differences in state of mood as measured by the Profile of Mood State (POMS)
Description
A psychological distress scale to measure mood disturbance in 6 domains - fatigue-inertia, vigor-activity, tension-anxiety, depression-dejection, anger-hostility, and confusion-bewilderment.
Time Frame
up to 8 week Exercise Intervention
Title
Group differences in learning and memory as measured by Controlled Oral Word Association Test (COWAT)
Description
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.
Time Frame
up to 8 week Exercise Intervention
Title
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
Description
Quality of life concerns related to fatigue will be assessed only in COPD patients with this questionnaire.
Time Frame
up to 8 week Exercise Intervention
Title
Peak Power and Strength by Keiser Resistance Training Equipment
Description
Changes in Peak Power and Strength measured through testing completed using Keiser Pneumatic Resistance Training Devices
Time Frame
up to 8 week Exercise Intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marielle Engelen, PhD
Phone
9792202282
Email
mpkj.engelen@ctral.org
First Name & Middle Initial & Last Name or Official Title & Degree
Sofie deWande, MS
Phone
979-422-1789
Email
research@ctral.org
Facility Information:
Facility Name
Texas A&M University
City
College Station
State/Province
Texas
ZIP/Postal Code
77843
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marielle P Engelen, Ph.D.
Phone
979-220-2282
Email
mpkj.engelen@ctral.org
First Name & Middle Initial & Last Name & Degree
Sofie deWandel
Phone
9794221789
Email
research@ctral.org
First Name & Middle Initial & Last Name & Degree
Marielle Engelen, Ph.D.
First Name & Middle Initial & Last Name & Degree
Nicolaas E Deutz, Ph.D.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing 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).
Learn more about this trial
COPD Circuit Exercise
We'll reach out to this number within 24 hrs