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COPD Circuit Exercise

24 mai 2022 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Anticipé)

200

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • États-Unis
    • Texas
      • College Station, Texas, États-Unis, 77843
        • Recrutement
        • Texas A&M University
        • Chercheur principal:
          • Marielle Engelen, Ph.D.
        • Chercheur principal:
          • Nicolaas E Deutz, Ph.D.
        • Contact:
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

30 ans à 85 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Whole-body protein and amino acid metabolism response to training
Délai: up to 8 weeks Exercise Intervention
Whole-body production rate measured after stable tracer administration
up to 8 weeks Exercise Intervention

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Body Composition using Dual Energy X-Ray Absorptiometry bone density
Délai: 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
Délai: 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
Délai: up to 8 week Exercise Intervention
Measurement of fat mass (kg)
up to 8 week Exercise Intervention
Bone mineral density by BIA
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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"
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Texas A&M University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

2 février 2021

Achèvement primaire (Anticipé)

5 mai 2023

Achèvement de l'étude (Anticipé)

5 mai 2024

Dates d'inscription aux études

Première soumission

10 décembre 2021

Première soumission répondant aux critères de contrôle qualité

24 mai 2022

Première publication (Réel)

27 mai 2022

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

27 mai 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

24 mai 2022

Dernière vérification

1 mai 2022

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2019-0149 (Autre identifiant: M D Anderson Cancer Center)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

INDÉCIS

Description du régime 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).

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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