Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Metabolic Costs of Daily Activities in Older Adults (CHORES-XL)

6 juni 2019 bijgewerkt door: University of Florida
The work will evaluate the metabolic costs for daily activities across the lifespan and evaluate the influence of having functional impairments.

Studie Overzicht

Toestand

Voltooid

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

269

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Florida
      • Gainesville, Florida, Verenigde Staten, 32611
        • UF Institute on Aging Clinical and Translational Research Building

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

20 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Community dwelling population

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
MET value
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Rating of perceived exertion
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Accelerometer signals to predict of energy expenditure
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Todd M Manini, PhD, University of Florida

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juli 2014

Primaire voltooiing (Werkelijk)

6 juni 2019

Studie voltooiing (Werkelijk)

6 juni 2019

Studieregistratiedata

Eerst ingediend

28 februari 2014

Eerst ingediend dat voldeed aan de QC-criteria

30 april 2014

Eerst geplaatst (Schatting)

2 mei 2014

Updates van studierecords

Laatste update geplaatst (Werkelijk)

7 juni 2019

Laatste update ingediend die voldeed aan QC-criteria

6 juni 2019

Laatst geverifieerd

1 juni 2019

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • IRB201501057-N
  • 5R01AG042525-05 (Subsidie/contract van de Amerikaanse NIH)
  • 087-2013 (Andere identificatie: Univeristy of Florida)
  • OCR15164 (Andere identificatie: University of Florida)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren