- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02129855
Metabolic Costs of Daily Activities in Older Adults (CHORES-XL)
June 6, 2019 updated by: University of Florida
The work will evaluate the metabolic costs for daily activities across the lifespan and evaluate the influence of having functional impairments.
Study Overview
Status
Completed
Conditions
Detailed Description
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.
Study Type
Observational
Enrollment (Actual)
269
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Florida
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Gainesville, Florida, United States, 32611
- UF Institute on Aging Clinical and Translational Research Building
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Community dwelling population
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
MET value
Time Frame: 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
Time Frame: 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
|
|
Relative metabolic cost to peak energy expenditure
Time Frame: 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
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rating of perceived exertion
Time Frame: 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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accelerometer signals to predict of energy expenditure
Time Frame: 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.
|
Participants will attend up to 4 visits within one month of enrollment to attain these data
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Todd M Manini, PhD, University of Florida
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2014
Primary Completion (Actual)
June 6, 2019
Study Completion (Actual)
June 6, 2019
Study Registration Dates
First Submitted
February 28, 2014
First Submitted That Met QC Criteria
April 30, 2014
First Posted (Estimate)
May 2, 2014
Study Record Updates
Last Update Posted (Actual)
June 7, 2019
Last Update Submitted That Met QC Criteria
June 6, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- IRB201501057-N
- 5R01AG042525-05 (U.S. NIH Grant/Contract)
- 087-2013 (Other Identifier: Univeristy of Florida)
- OCR15164 (Other Identifier: University of Florida)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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