- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02129855
Metabolic Costs of Daily Activities in Older Adults (CHORES-XL)
6 juni 2019 uppdaterad av: University of Florida
The work will evaluate the metabolic costs for daily activities across the lifespan and evaluate the influence of having functional impairments.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Faktisk)
269
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Florida
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Gainesville, Florida, Förenta staterna, 32611
- UF Institute on Aging Clinical and Translational Research Building
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
20 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Community dwelling population
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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MET value
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
|
Relative metabolic cost to resting energy expenditure
Tidsram: Participants will attend up to 4 visits within one month of enrollment to attain these data
|
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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Rating of perceived exertion
Tidsram: 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.
|
Participants will attend up to 4 visits within one month of enrollment to attain these data
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Accelerometer signals to predict of energy expenditure
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Todd M Manini, PhD, University of Florida
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juli 2014
Primärt slutförande (Faktisk)
6 juni 2019
Avslutad studie (Faktisk)
6 juni 2019
Studieregistreringsdatum
Först inskickad
28 februari 2014
Först inskickad som uppfyllde QC-kriterierna
30 april 2014
Första postat (Uppskatta)
2 maj 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
7 juni 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
6 juni 2019
Senast verifierad
1 juni 2019
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- IRB201501057-N
- 5R01AG042525-05 (U.S.S. NIH-anslag/kontrakt)
- 087-2013 (Annan identifierare: Univeristy of Florida)
- OCR15164 (Annan identifierare: University of Florida)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
OBESLUTSAM
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