Functional LimitationCHORES-XLNCT02129855
Metabolic Costs of Daily Activities in Older Adults
An observational study of Functional Limitation, run by University of Florida at 1 site in United States.
Trial summary
The work will evaluate the metabolic costs for daily activities across the lifespan and evaluate the influence of having functional impairments. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Functional Limitation
- How many people
- 269 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to 6 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community dwelling population
Who may be able to join
- 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
Who cannot join
- 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)
Show all 44Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UF Institute on Aging Clinical and Translational Research Building
Gainesville, Florida, 32611
About this study
The work will evaluate the metabolic costs for daily activities across the lifespan and evaluate the influence of having functional impairments.
Read the 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.
- Conditions
- Functional Limitation
What is being measured
The primary outcome is the main question the study is designed to answer.
MET value
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.
Measured: Participants will attend up to 4 visits within one month of enrollment to attain these data
Metabolic economy
Metabolic economy is the energy expended for a given work rate.
Measured: Participants will attend up to 4 visits within one month of enrollment to attain these data
Relative metabolic cost to peak energy expenditure
Relative metabolic cost is function of peak oxygen consumption
Measured: Participants will attend up to 4 visits within one month of enrollment to attain these data
Relative metabolic cost to resting energy expenditure
Relative metabolic cost as a function of resting
Measured: Participants will attend up to 4 visits within one month of enrollment to attain these data
Secondary outcomes (1)
Rating of perceived exertion
Ratings of perceived exertion will be collected during all activities. Investigators will use the Category Ratio scale-10 scale developed by Borg in 1982.
Measured: Participants will attend up to 4 visits within one month of enrollment to attain these data
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2014 (estimated)
- Study startJul 2014
- Primary completion6 Jun 2019
- Study completion6 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional LimitationStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 269 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Wake Forest University, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Todd M Manini, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02129855
- Sponsor's protocol ID
- IRB201501057-N
- Other IDs
- 5R01AG042525-05, 087-2013, OCR15164
- Acronym
- CHORES-XL
- Status last verified
- Jun 2019
- First submitted
- 28 Feb 2014
- Last updated
- 7 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Costs of Daily Activities in Older Adults
- ClinicalTrials.gov ID
- NCT02129855
- Acronym / sponsor ID
- CHORES-XL / IRB201501057-N
- Conditions
- Functional Limitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 269 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Wake Forest University, National Institute on Aging (NIA)
- Study start
- Jul 2014
- Primary completion
- 6 Jun 2019 (actual)
- Study completion
- 6 Jun 2019 (actual)
- First posted
- 2 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The work will evaluate the metabolic costs for daily activities across the lifespan and evaluate the influence of having functional impairments.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community dwelling population
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (44 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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
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
1 secondary outcome
Rating of perceived exertion
Time frame: Participants will attend up to 4 visits within one month of enrollment to attain these data
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2019.
- University of Florida Institute on AgingLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Functional Limitation
Not yet recruiting
Pilates vs. Core Stabilization for Balance and Mobility in Elderly Type 2 Diabetics
Mellitus Balance Deficits Postural Balance Mobility Limitation, Type 2 Diabetes Mellitus
Not yet recruiting
EFFECT OF ADDING BLOOD FLOW RESTRICTION TRAINING TO CLOSED CHAIN EXERCISE IN KNEE OSTEOARTHRITIS
Knee Osteoarthritis
Not yet recruitingObservational study
Advanced Multisensorial System for Automatic Assessment of Neurological Disorders in Smart Spaces-Universidad Rey Juan Carlos (URJC)
Neurologic Disorders
Recruiting
6-Weeks of Blood Flow Restriction Training on Immune Cell Function and Bioenergetics
Type 2 Diabetes
Not yet recruiting
"CORE Training for Musculoskeletal Health: A Study on Adaptive Exercise Protocols"
Core Muscle Weakness, Postural Control Deficit
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd M Manini, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Limitation, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 44 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MET value (time frame: Participants will attend up to 4 visits within one month of enrollment to attain these data). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2019.