Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05395390
Other study ID # 2019-0149
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 2, 2021
Est. completion date May 5, 2024

Study information

Verified date May 2022
Source Texas A&M University
Contact Marielle Engelen, PhD
Phone 9792202282
Email mpkj.engelen@ctral.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date May 5, 2024
Est. primary completion date May 5, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 85 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Texas A&M University College Station Texas

Sponsors (1)

Lead Sponsor Collaborator
Texas A&M University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Whole-body protein and amino acid metabolism response to training Whole-body production rate measured after stable tracer administration up to 8 weeks Exercise Intervention
Secondary 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 up to 8 week Exercise Intervention
Secondary Body Composition using Dual Energy X-Ray Absorptiometry Muscle Measurement of muscle mass (kg) up to 8 week Exercise Intervention
Secondary Body Composition using Dual Energy X-Ray Absorptiometry Fat Measurement of fat mass (kg) up to 8 week Exercise Intervention
Secondary 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. up to 8 week Exercise Intervention
Secondary Handgrip strength dynamometry by Handgrip Dynamometer Difference and changes in handgrip strength pre and post exercise up to 8 week Exercise Intervention
Secondary 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. up to 8 week Exercise Intervention
Secondary Skeletal muscle strength of leg by Kin-Com Difference in muscle strength of leg using kin-com machine between pre and post exercise intervention. up to 8 week Exercise Intervention
Secondary C-reactive protein by Blood Analysis Differences and changes in the concentration of the inflammatory marker C-reactive protein up to 8 week Exercise Intervention
Secondary 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. up to 8 week Exercise Intervention
Secondary 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. up to 8 week Exercise Intervention
Secondary 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. up to 8 week Exercise Intervention
Secondary 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. up to 8 week Exercise Intervention
Secondary 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. up to 8 week Exercise Intervention
Secondary COPD Assessment Test Self-administered questionnaire regarding impact of COPD on daily life up to 8 week Exercise Intervention
Secondary 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. up to 8 week Exercise Intervention
Secondary 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. up to 8 week Exercise Intervention
Secondary 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. up to 8 week Exercise Intervention
Secondary 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. up to 8 week Exercise Intervention
Secondary 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. up to 8 week Exercise Intervention
Secondary 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. up to 8 week Exercise Intervention
Secondary 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 up to 8 week Exercise Intervention
See also
  Status Clinical Trial Phase
Completed NCT05047692 - Safety and Immunogenicity Study of AdCLD-CoV19-1: A COVID-19 Preventive Vaccine in Healthy Volunteers Phase 1
Recruiting NCT04395768 - International ALLIANCE Study of Therapies to Prevent Progression of COVID-19 Phase 2
Terminated NCT04555096 - A Trial of GC4419 in Patients With Critical Illness Due to COVID-19 Phase 2
Completed NCT04508777 - COVID SAFE: COVID-19 Screening Assessment for Exposure
Completed NCT04506268 - COVID-19 SAFE Enrollment N/A
Completed NCT04961541 - Evaluation of the Safety and Immunogenicity of Influenza and COVID-19 Combination Vaccine Phase 1/Phase 2
Active, not recruiting NCT04546737 - Study of Morphological, Spectral and Metabolic Manifestations of Neurological Complications in Covid-19 Patients N/A
Terminated NCT04542993 - Can SARS-CoV-2 Viral Load and COVID-19 Disease Severity be Reduced by Resveratrol-assisted Zinc Therapy Phase 2
Terminated NCT04581915 - PHRU CoV01 A Trial of Triazavirin (TZV) for the Treatment of Mild-moderate COVID-19 Phase 2/Phase 3
Not yet recruiting NCT04543006 - Persistence of Neutralizing Antibodies 6 and 12 Months After a Covid-19 N/A
Completed NCT04532294 - Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2/COVID-19) Neutralizing Antibody in Healthy Participants Phase 1
Completed NCT04494646 - BARCONA: A Study of Effects of Bardoxolone Methyl in Participants With SARS-Corona Virus-2 (COVID-19) Phase 2
Completed NCT04387292 - Ocular Sequelae of Patients Hospitalized for Respiratory Failure During the COVID-19 Epidemic N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Not yet recruiting NCT04527211 - Effectiveness and Safety of Ivermectin for the Prevention of Covid-19 Infection in Colombian Health Personnel Phase 3
Completed NCT04537663 - Prevention Of Respiratory Tract Infection And Covid-19 Through BCG Vaccination In Vulnerable Older Adults Phase 4
Completed NCT04979858 - Reducing Spread of COVID-19 in a University Community Setting: Role of a Low-Cost Reusable Form-Fitting Fabric Mask N/A
Not yet recruiting NCT05038449 - Study to Evaluate the Efficacy and Safety of Colchicine Tablets in Patients With COVID-19 N/A
Completed NCT04610502 - Efficacy and Safety of Two Hyperimmune Equine Anti Sars-CoV-2 Serum in COVID-19 Patients Phase 2
Active, not recruiting NCT06042855 - ACTIV-6: COVID-19 Study of Repurposed Medications - Arm G (Metformin) Phase 3