- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02129855
Metabolic Costs of Daily Activities in Older Adults (CHORES-XL)
6 juin 2019 mis à jour par: University of Florida
The work will evaluate the metabolic costs for daily activities across the lifespan and evaluate the influence of having functional impairments.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
The work will evaluate the metabolic costs for daily activities across the lifespan and evaluate the influence of having functional impairments.
The project will simultaneously conduct a cross-sectional and a case-control study.
The primary aim will investigate cross-sectional association between older age and the energy expenditure of daily activities by recruiting approximately 25 adults in each of 7 age groups (20-30,30-40,40-50,50-60,60-70,70-80,80+) for a total of 180 individuals.
A secondary aim will investigate the effect of functional impairments on the energy expenditure of daily activities by conducting a case-control study.
An additional 25 older adults with functional impairment will be recruited in each age decade (60-70, 70-80, and 80+ years old) to accomplish this aim.
Additional outcomes will evaluate rating of perceived exertion differences in daily activities.
A tertiary aim will investigate using accelerometers to predict the metabolic costs of daily activities.
Type d'étude
Observationnel
Inscription (Réel)
269
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.
Lieux d'étude
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Florida
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Gainesville, Florida, États-Unis, 32611
- UF Institute on Aging Clinical and Translational Research Building
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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
20 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Community dwelling population
La description
Inclusion Criteria:
- Age 20+ years old
- Community dwelling adults without significant health issues
- Willingness to undergo all testing procedures
- Weight stable for at least three months
- Able to understand and speak English
Exclusion Criteria:
- Failure to provide informed consent
- A 10% enrollment limit will be applied to avid exercisers in each age decade. Avid exercises will be defined as doing structured exercise 3 or more days per week (e.g. jogging, sports etc., walkers will be permitted in the study). Based on our experience, avid exercisers volunteer for this type of research at a high rate and thus the investigators will limit these individuals to prevent a biased comparison
- Use of walker (use of a cane is permitted)
- Lower extremity amputation
- Develops chest pain or severe shortness of breath during physical stress
- Post-stroke syndrome causing ambulatory deficits (other stroke survivors permitted)
- Pacemaker
- Needs assistance with basic activities of daily living: feeding, dressing, continence, bathing, toileting, and transferring from a bed to a chair or from a chair to walking
- Lives in a nursing home; persons living in assisted or independent housing are not excluded
- For adults over the age of 60: >2 errors on the Short, portable mental status questionnaire administered after written informed consent
- Excessive alcohol or substance abuse within six months or consumption of >14 alcohol drinks/week
- For women who are child-bearing age (up to 62 years of age): pregnant or breast-feeding
- Participation in a structured weight loss program or fad diet in the last month;
- Weight reduction surgery in the past year
- Known neuromuscular disorder (Rhabdomyolysis, Myasthenia Gravis, Ataxia, Apraxia, post-polio syndrome, mitochondrial myopathy, chronic fatigue syndrome etc.)
- Diagnosed neuropathy that causes pain
- Symptomatic peripheral arterial disease
- Unable to communicate because of severe hearing loss or speech disorder
- Severe visual impairment, which would preclude completion of the assessments
- Progressive, degenerative neurologic disease, e.g., Parkinson's Disease, Multiple Sclerosis, Amyotrophic lateral sclerosis
- Severe rheumatologic or orthopedic diseases, e.g., awaiting joint replacement, active inflammatory disease; self-reported severe osteoarthritis
- Terminal illness, as determined by the participant
- Severe pulmonary disease, requiring the use of supplemental oxygen or steroid therapy
- Severe cardiac disease, including New York Heart Association Class III or IV congestive heart failure, clinically significant aortic stenosis, recent history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina
- Other significant comorbid disease discovered during medical screening, e.g. renal failure on hemodialysis, psychiatric disorder (e.g. bipolar, schizophrenia); chronic fatigue syndrome etc…
- Liver diseases: chronic hepatitis, an inflammatory disease, or cirrhosis
- Pregnancy. Participants within childbearing age will have a pregnancy test.
- Contraindications to graded exercise testing according to the American Thoracic Society:
- Acute myocardial infarction (<6 months since event)
- Unstable angina
- Uncontrolled arrhythmias causing symptoms or hemodynamic compromise
- Syncope
- Active endocarditis
- Acute myocarditis or pericarditis
- Symptomatic severe aortic stenosis
- Uncontrolled heart failure
- Acute pulmonary embolus or pulmonary infarction
- Thrombosis of lower extremity
- Suspected dissecting aneurysm
- Uncontrolled asthmas
- Pulmonary edema
- Room air desaturation at rest < 85%
- Respiratory failure
- Acute non cardiopulmonary disorder that may affect exercise performance
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
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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MET value
Délai: Participants will attend up to 4 visits within one month of enrollment to attain these data
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MET value of physical activities defined as the oxygen uptake (VO2 = milliliter• min-1•kg-1) during a steady state rate expressed as a function 3.5 milliliter• min-1•kg-1.
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Participants will attend up to 4 visits within one month of enrollment to attain these data
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Metabolic economy
Délai: Participants will attend up to 4 visits within one month of enrollment to attain these data
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Metabolic economy is the energy expended for a given work rate.
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Participants will attend up to 4 visits within one month of enrollment to attain these data
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Relative metabolic cost to peak energy expenditure
Délai: Participants will attend up to 4 visits within one month of enrollment to attain these data
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Relative metabolic cost is function of peak oxygen consumption
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Participants will attend up to 4 visits within one month of enrollment to attain these data
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Relative metabolic cost to resting energy expenditure
Délai: Participants will attend up to 4 visits within one month of enrollment to attain these data
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Relative metabolic cost as a function of resting
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Participants will attend up to 4 visits within one month of enrollment to attain these data
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Rating of perceived exertion
Délai: Participants will attend up to 4 visits within one month of enrollment to attain these data
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Ratings of perceived exertion will be collected during all activities.
Investigators will use the Category Ratio scale-10 scale developed by Borg in 1982.
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Participants will attend up to 4 visits within one month of enrollment to attain these data
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Accelerometer signals to predict of energy expenditure
Délai: Participants will attend up to 4 visits within one month of enrollment to attain these data
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A tertiary outcome is to validate body worn monitors (e.g.
accelerometers) to estimate the type and intensity of activity for accurate estimation of energy expenditure.
A predicted metabolic equivalent value will be estimated for each activity.
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Participants will attend up to 4 visits within one month of enrollment to attain these data
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Todd M Manini, PhD, University of Florida
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Liens utiles
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
1 juillet 2014
Achèvement primaire (Réel)
6 juin 2019
Achèvement de l'étude (Réel)
6 juin 2019
Dates d'inscription aux études
Première soumission
28 février 2014
Première soumission répondant aux critères de contrôle qualité
30 avril 2014
Première publication (Estimation)
2 mai 2014
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
7 juin 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
6 juin 2019
Dernière vérification
1 juin 2019
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- IRB201501057-N
- 5R01AG042525-05 (Subvention/contrat des NIH des États-Unis)
- 087-2013 (Autre identifiant: Univeristy of Florida)
- OCR15164 (Autre identifiant: University of Florida)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
INDÉCIS
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 .