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COPD Circuit Exercise

24 maggio 2022 aggiornato da: Marielle PKJ Engelen, PhD, Texas A&M University

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Anticipato)

200

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Stati Uniti
    • Texas
      • College Station, Texas, Stati Uniti, 77843
        • Reclutamento
        • Texas A&M University
        • Investigatore principale:
          • Marielle Engelen, Ph.D.
        • Investigatore principale:
          • Nicolaas E Deutz, Ph.D.
        • Contatto:
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 30 anni a 85 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Whole-body protein and amino acid metabolism response to training
Lasso di tempo: up to 8 weeks Exercise Intervention
Whole-body production rate measured after stable tracer administration
up to 8 weeks Exercise Intervention

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Body Composition using Dual Energy X-Ray Absorptiometry bone density
Lasso di tempo: up to 8 week Exercise Intervention
Measurement of bone mineral density (g/cm^2)between COPD patients and healthy older adults using DXA
up to 8 week Exercise Intervention
Body Composition using Dual Energy X-Ray Absorptiometry Muscle
Lasso di tempo: up to 8 week Exercise Intervention
Measurement of muscle mass (kg)
up to 8 week Exercise Intervention
Body Composition using Dual Energy X-Ray Absorptiometry Fat
Lasso di tempo: up to 8 week Exercise Intervention
Measurement of fat mass (kg)
up to 8 week Exercise Intervention
Bone mineral density by BIA
Lasso di tempo: up to 8 week Exercise Intervention
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
Handgrip strength dynamometry by Handgrip Dynamometer
Lasso di tempo: up to 8 week Exercise Intervention
Difference and changes in handgrip strength pre and post exercise
up to 8 week Exercise Intervention
6 minute walk test distance by 6 minute walk test
Lasso di tempo: up to 8 week Exercise Intervention
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
Skeletal muscle strength of leg by Kin-Com
Lasso di tempo: up to 8 week Exercise Intervention
Difference in muscle strength of leg using kin-com machine between pre and post exercise intervention.
up to 8 week Exercise Intervention
C-reactive protein by Blood Analysis
Lasso di tempo: up to 8 week Exercise Intervention
Differences and changes in the concentration of the inflammatory marker C-reactive protein
up to 8 week Exercise Intervention
Attention and executive functions measured by Trail Making Test (TMT)
Lasso di tempo: up to 8 week Exercise Intervention
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
Attention and executive functions measured by Stroop Color-Word Test (SCWT)
Lasso di tempo: up to 8 week Exercise Intervention
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
Gut function as reported by "The Gastrointestinal Symptom Rating Scale"
Lasso di tempo: up to 8 week Exercise Intervention
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
Physical activity as reported by "Physical Activity Scale for the Elderly
Lasso di tempo: up to 8 week Exercise Intervention
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
State of mood as measured by the Hospital Anxiety and Depression Scale (HADS)
Lasso di tempo: up to 8 week Exercise Intervention
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
COPD Assessment Test
Lasso di tempo: up to 8 week Exercise Intervention
Self-administered questionnaire regarding impact of COPD on daily life
up to 8 week Exercise Intervention
3-day diet diary
Lasso di tempo: up to 8 week Exercise Intervention
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
Group differences in learning and memory as measured by Digit Span
Lasso di tempo: up to 8 week Exercise Intervention
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
Group differences in overall cognitive abilities as measured by Montreal Cognitive Assessment (MoCA)
Lasso di tempo: up to 8 week Exercise Intervention
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
Group differences in state of mood as measured by the Profile of Mood State (POMS)
Lasso di tempo: up to 8 week Exercise Intervention
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
Group differences in learning and memory as measured by Controlled Oral Word Association Test (COWAT)
Lasso di tempo: up to 8 week Exercise Intervention
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
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
Lasso di tempo: up to 8 week Exercise Intervention
Quality of life concerns related to fatigue will be assessed only in COPD patients with this questionnaire.
up to 8 week Exercise Intervention
Peak Power and Strength by Keiser Resistance Training Equipment
Lasso di tempo: up to 8 week Exercise Intervention
Changes in Peak Power and Strength measured through testing completed using Keiser Pneumatic Resistance Training Devices
up to 8 week Exercise Intervention

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Texas A&M University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

2 febbraio 2021

Completamento primario (Anticipato)

5 maggio 2023

Completamento dello studio (Anticipato)

5 maggio 2024

Date di iscrizione allo studio

Primo inviato

10 dicembre 2021

Primo inviato che soddisfa i criteri di controllo qualità

24 maggio 2022

Primo Inserito (Effettivo)

27 maggio 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

27 maggio 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 maggio 2022

Ultimo verificato

1 maggio 2022

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2019-0149 (Altro identificatore: M D Anderson Cancer Center)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano IPD

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).

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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