Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
269 participants
OBSERVATIONAL
2014-07-31
2019-06-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Cardiovascular Risk Prevention Among Night Workers
NCT02899442
Quality of Life in Patients With Chronic Disease
NCT03925805
The Lake Nona Life Project
NCT02533804
Diet and Activity Promotion Among Older Working Adults
NCT01233063
Validation of a Comprehensive Older Adult Screening Tool (COAST)
NCT03185585
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
CROSS_SECTIONAL
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
20 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Wake Forest University
OTHER
National Institute on Aging (NIA)
NIH
University of Florida
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Todd M Manini, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UF Institute on Aging Clinical and Translational Research Building
Gainesville, Florida, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
University of Florida Institute on Aging
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
087-2013
Identifier Type: OTHER
Identifier Source: secondary_id
OCR15164
Identifier Type: OTHER
Identifier Source: secondary_id
IRB201501057-N
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.