Clinical trial NCT05395390: COPD Circuit Exercise
Official title: Circuit-Exercise Training on Subjects With and Without Chronic Respiratory Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: OSA
Covid19
Residual Symptoms of COVID 19
COPD
Lead sponsor: Texas A&M University
Sponsor class: OTHER
First posted: 2022-05-27
Enrollment: 200
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Whole-body protein and amino acid metabolism response to training
timeFrame: up to 8 weeks Exercise Intervention
Secondary outcomes:
measure: Body Composition using Dual Energy X-Ray Absorptiometry bone density
timeFrame: up to 8 week Exercise Intervention
measure: Body Composition using Dual Energy X-Ray Absorptiometry Muscle
timeFrame: up to 8 week Exercise Intervention
measure: Body Composition using Dual Energy X-Ray Absorptiometry Fat
timeFrame: up to 8 week Exercise Intervention
measure: Bone mineral density by BIA
timeFrame: up to 8 week Exercise Intervention
measure: Handgrip strength dynamometry by Handgrip Dynamometer
timeFrame: up to 8 week Exercise Intervention
measure: 6 minute walk test distance by 6 minute walk test
timeFrame: up to 8 week Exercise Intervention
measure: Skeletal muscle strength of leg by Kin-Com
timeFrame: up to 8 week Exercise Intervention
measure: C-reactive protein by Blood Analysis
timeFrame: up to 8 week Exercise Intervention
measure: Attention and executive functions measured by Trail Making Test (TMT)
timeFrame: up to 8 week Exercise Intervention
measure: Attention and executive functions measured by Stroop Color-Word Test (SCWT)
timeFrame: up to 8 week Exercise Intervention
measure: Gut function as reported by "The Gastrointestinal Symptom Rating Scale"
timeFrame: up to 8 week Exercise Intervention
measure: Physical activity as reported by "Physical Activity Scale for the Elderly
timeFrame: up to 8 week Exercise Intervention
measure: State of mood as measured by the Hospital Anxiety and Depression Scale (HADS)
timeFrame: up to 8 week Exercise Intervention
measure: COPD Assessment Test
timeFrame: up to 8 week Exercise Intervention
measure: 3-day diet diary
timeFrame: up to 8 week Exercise Intervention
measure: Group differences in learning and memory as measured by Digit Span
timeFrame: up to 8 week Exercise Intervention
measure: Group differences in overall cognitive abilities as measured by Montreal Cognitive Assessment (MoCA)
timeFrame: up to 8 week Exercise Intervention
measure: Group differences in state of mood as measured by the Profile of Mood State (POMS)
timeFrame: up to 8 week Exercise Intervention
measure: Group differences in learning and memory as measured by Controlled Oral Word Association Test (COWAT)
timeFrame: up to 8 week Exercise Intervention
measure: Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
timeFrame: up to 8 week Exercise Intervention
measure: Peak Power and Strength by Keiser Resistance Training Equipment
timeFrame: up to 8 week Exercise Intervention
Other outcomes:
Locations:
city: College Station
country: United States
facility: Texas A&M University
state: Texas
Study officials:
References: