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

Texas A&M University1 site in 1 country72 target enrollmentFebruary 2, 2021

ConditionsOSA Covid19 Residual Symptoms of COVID 19 COPD

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: OSA
Sponsor: Texas A&M University
Enrollment: 72
Locations: 1
Primary Endpoint: Whole-body protein and amino acid metabolism response to training
Status: Completed
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2, 2021

End Date

August 7, 2023

Last Updated

7 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Texas A&M University

Responsible Party

Principal Investigator

Marielle PKJ Engelen, PhD

Professor

Texas A&M University

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

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.

Outcomes

Primary Outcomes

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

Body Composition using Dual Energy X-Ray Absorptiometry bone density(up to 8 week Exercise Intervention)
COPD Assessment Test(up to 8 week Exercise Intervention)
Body Composition using Dual Energy X-Ray Absorptiometry Muscle(up to 8 week Exercise Intervention)
Body Composition using Dual Energy X-Ray Absorptiometry Fat(up to 8 week Exercise Intervention)
Bone mineral density by BIA(up to 8 week Exercise Intervention)
Handgrip strength dynamometry by Handgrip Dynamometer(up to 8 week Exercise Intervention)
Attention and executive functions measured by Trail Making Test (TMT)(up to 8 week Exercise Intervention)
State of mood as measured by the Hospital Anxiety and Depression Scale (HADS)(up to 8 week Exercise Intervention)
3-day diet diary(up to 8 week Exercise Intervention)
Group differences in learning and memory as measured by Digit Span(up to 8 week Exercise Intervention)
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)(up to 8 week Exercise Intervention)
6 minute walk test distance by 6 minute walk test(up to 8 week Exercise Intervention)
Skeletal muscle strength of leg by Kin-Com(up to 8 week Exercise Intervention)
C-reactive protein by Blood Analysis(up to 8 week Exercise Intervention)
Attention and executive functions measured by Stroop Color-Word Test (SCWT)(up to 8 week Exercise Intervention)
Gut function as reported by "The Gastrointestinal Symptom Rating Scale"(up to 8 week Exercise Intervention)
Physical activity as reported by "Physical Activity Scale for the Elderly(up to 8 week Exercise Intervention)
Peak Power and Strength by Keiser Resistance Training Equipment(up to 8 week Exercise Intervention)
Group differences in overall cognitive abilities as measured by Montreal Cognitive Assessment (MoCA)(up to 8 week Exercise Intervention)
Group differences in state of mood as measured by the Profile of Mood State (POMS)(up to 8 week Exercise Intervention)
Group differences in learning and memory as measured by Controlled Oral Word Association Test (COWAT)(up to 8 week Exercise Intervention)