- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02129855
Metabolic Costs of Daily Activities in Older Adults (CHORES-XL)
6 giugno 2019 aggiornato da: University of Florida
The work will evaluate the metabolic costs for daily activities across the lifespan and evaluate the influence of having functional impairments.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Osservativo
Iscrizione (Effettivo)
269
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
Florida
-
Gainesville, Florida, Stati Uniti, 32611
- UF Institute on Aging Clinical and Translational Research Building
-
-
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
20 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
Community dwelling population
Descrizione
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
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
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
MET value
Lasso di tempo: Participants will attend up to 4 visits within one month of enrollment to attain these data
|
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.
|
Participants will attend up to 4 visits within one month of enrollment to attain these data
|
|
Metabolic economy
Lasso di tempo: Participants will attend up to 4 visits within one month of enrollment to attain these data
|
Metabolic economy is the energy expended for a given work rate.
|
Participants will attend up to 4 visits within one month of enrollment to attain these data
|
|
Relative metabolic cost to peak energy expenditure
Lasso di tempo: Participants will attend up to 4 visits within one month of enrollment to attain these data
|
Relative metabolic cost is function of peak oxygen consumption
|
Participants will attend up to 4 visits within one month of enrollment to attain these data
|
|
Relative metabolic cost to resting energy expenditure
Lasso di tempo: Participants will attend up to 4 visits within one month of enrollment to attain these data
|
Relative metabolic cost as a function of resting
|
Participants will attend up to 4 visits within one month of enrollment to attain these data
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Rating of perceived exertion
Lasso di tempo: Participants will attend up to 4 visits within one month of enrollment to attain these data
|
Ratings of perceived exertion will be collected during all activities.
Investigators will use the Category Ratio scale-10 scale developed by Borg in 1982.
|
Participants will attend up to 4 visits within one month of enrollment to attain these data
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Accelerometer signals to predict of energy expenditure
Lasso di tempo: Participants will attend up to 4 visits within one month of enrollment to attain these data
|
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.
|
Participants will attend up to 4 visits within one month of enrollment to attain these data
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Todd M Manini, PhD, University of Florida
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Collegamenti utili
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
1 luglio 2014
Completamento primario (Effettivo)
6 giugno 2019
Completamento dello studio (Effettivo)
6 giugno 2019
Date di iscrizione allo studio
Primo inviato
28 febbraio 2014
Primo inviato che soddisfa i criteri di controllo qualità
30 aprile 2014
Primo Inserito (Stima)
2 maggio 2014
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
7 giugno 2019
Ultimo aggiornamento inviato che soddisfa i criteri QC
6 giugno 2019
Ultimo verificato
1 giugno 2019
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- IRB201501057-N
- 5R01AG042525-05 (Sovvenzione/contratto NIH degli Stati Uniti)
- 087-2013 (Altro identificatore: Univeristy of Florida)
- OCR15164 (Altro identificatore: University of Florida)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
INDECISO
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 .