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

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ClinicalTrials.gov Identifier: NCT02129855
Recruitment Status : Completed
First Posted : May 2, 2014
Last Update Posted : June 7, 2019
Sponsor:
Collaborators:
Wake Forest University
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Florida

Brief Summary:
The work will evaluate the metabolic costs for daily activities across the lifespan and evaluate the influence of having functional impairments.

Condition or disease
Functional Limitation

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.

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Study Type : Observational
Actual Enrollment : 269 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Metabolic Costs of Daily Activities in Older Adults
Study Start Date : July 2014
Actual Primary Completion Date : June 6, 2019
Actual Study Completion Date : June 6, 2019



Primary Outcome Measures :
  1. 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.

  2. Metabolic economy [ Time Frame: 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.

  3. 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 ]
    Relative metabolic cost is function of peak oxygen consumption

  4. 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


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community dwelling population
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02129855


Locations
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United States, Florida
UF Institute on Aging Clinical and Translational Research Building
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Wake Forest University
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Todd M Manini, PhD University of Florida

Additional Information:
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02129855     History of Changes
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 )
First Posted: May 2, 2014    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided