Lifestyle Intervention Trial in Obese Elderly (LITOE)

January 17, 2020 updated by: Dennis Villareal, Biomedical Research Institute of New Mexico

Exercise Interventions During Voluntary Weight Loss in Obese Older Adults

Obesity causes frailty in obese older adults by exacerbating the age-related decline in physical function. However, appropriate management of obesity in older adults is controversial. Weight loss without exercise could worsen frailty by accelerating the usual age-related decline in muscle and bone mass that leads to sarcopenia and osteopenia, respectively. Because of the important problem of frailty in obese older adults, it is important to determine the most efficacious approach in reducing, or even reversing frailty in this population. The primary objective of this proposal is to evaluate which distinct type of physical exercise (resistance, aerobic, or combined resistance + aerobic) is most efficacious in preventing the weight-loss-induced reduction in muscle and bone mass and reversing frailty in obese older adults.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

  • United States
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • New Mexico VA Medical Center and University of New Mexico School of Medicine
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years to 85 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 65-85 years old
  • Obese men and women (BMI > or equal to 30 kg/m2)
  • Stable weight (±2 kg) during the last 6 mos.
  • Must be sedentary (regular exercise <1 h/wk or <2 x/wk for the last 6 mos.)
  • Be judged, during the initial screening, to be well motivated and reliable

Exclusion Criteria:

  • Any major chronic diseases
  • Any condition or unstable diseases that would interfere with exercise or dietary restriction, in which exercise or dietary restriction are contraindicated, or that would interfere with interpretation of results that include but are not limited to:
  • Cardiopulmonary disease (e.g., recent MI, unstable angina, stroke etc.)
  • Severe orthopedic/musculoskeletal or neuromuscular impairments that would contraindicate participation in exercise
  • Visual or hearing impairments that interfere with following directions
  • Diagnosis of dementia
  • History of malignancy during the past 5 yr
  • Recent use of bone acting drugs (e.g. use of estrogen, or androgen containing compound, raloxifene, calcitonin, parathyroid hormone during the past year or biphosphonates during the last two years)
  • Individuals on insulin or with a fasting blood glucose of > 140mg/dl, and/or a 2 hour post-glucose of >250 mg/dl
  • BMD t-scores of <-2.3 of the lumbar spine and proximal femur
  • serum creatinine >2.0 mg/dl
  • No commitments, life situations or conditions that would interfere with their participation in the study

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Diet + Resistance Exercise Training
Weekly behavioral/diet-induced weight loss plus supervised resistance exercise training three times a week
Behavioral: Diet + Resistance Training
Behavioral Therapy through a lifestyle modification program, Diet therapy once weekly through a dietician prescribed diet for 26 weeks, and resistance exercise training 3-days/week for 24 weeks.
Experimental: Diet + Aerobic Exercise Training
Weekly behavioral/diet-induced weight loss plus supervised aerobic exercise training three times a week
Behavioral: Diet + Aerobic Training
Behavioral Therapy through a lifestyle modification program, Diet therapy once weekly through a dietician prescribed diet for 26 weeks, and aerobic exercise training 3-days/week for 24 weeks
Experimental: Diet + Combined Aerobic/Resistance Exercise
Weekly behavioral/diet-induced weight loss plus combined supervised resistance exercise training and aerobic exercise training three times a week
Behavioral: Diet + Resistance/Aerobic Exercise
Behavioral Therapy through a lifestyle modification program, Diet therapy once weekly through a dietician prescribed diet for 26 weeks, and combined resistance/aerobic exercise training 3-days/week for 24 weeks
No Intervention: Control Group (No Diet/No Exercise)
No diet No exercise training

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Physical Function
Time Frame: 6 Months
The Physical Performance Test includes seven standardized tasks (walking 15.2 m [50 ft], putting on and removing a coat, picking up a penny, standing up from a chair, lifting a book, climbing one flight of stairs, and performing a progressive Romberg test) plus two additional tasks (going up and down four flights of stairs and making a 360-degree turn). The score for each task ranges from 0 to 4, with higher scores indicating better physical performance; a perfect score would be 36.
6 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in dynamic balance
Time Frame: 6 months
Assessed by the obstacle course
6 months
Change in static balance
Time Frame: 6 months
Assessed by one leg stance
6 months
Change in subjective ability to function
Time Frame: 6 months
Assessed by Functional Status Questionnaire (score range: 0 to 36 with higher scores indicating better function)
6 months
Change in mood
Time Frame: 6 months
Assessed by geriatric depression scale (score range: 0 to 30, where lower scores indicating better mood)
6 months
Change in Medical Outcomes 36-Item short form Health survey (SF-36)
Time Frame: 6 months
Assessed by Physical component summary and mental component summary score (score range 0 to 100, with higher scores indicating better health status)
6 months
Change in Impact of Weight on Quality of Life_Lite (IWQOL-lite) score
Time Frame: 6 months
Assessed by IWQO-liteL questionnaire
6 months
Change in serum lipids
Time Frame: 6 months
Assessed by automated enzymatic/colorimetric assays
6 months
Change in habitual physical activity assessed by questionnaires
Time Frame: 6 months
Using the Stanford physical activity questionnaire (score range: 0 to 40 with higher scores indicating higher physical activity levels)
6 months
Change in habitual physical activity measured objectively
Time Frame: 6 months
Using accelerometers
6 months
Change in lean mass
Time Frame: 6 months
Assessed using dual energy x-ray absorptiometry (DXA)
6 months
Change in fat mass
Time Frame: 6 months
Assessed using DXA
6 months
Change in muscle strength
Time Frame: 6 months
Assessed using 1-repetition maximum and dynamometry
6 months
Change in gait speed
Time Frame: 6 months
Measured as time to walk a certain distance
6 months
Change in areal bone mineral density
Time Frame: 6 months
Assessed by using DXA
6 months
Change in biochemical marker for bone turnover and bone metabolism
Time Frame: 6 months
Assessed by using enzyme linked immunoabsorbent assay and radioimmunoassay
6 months
Change in circulating cytokines
Time Frame: 6 months
Assessed by using enzyme linked immunoassay
6 months
Change in adipocytokines
Time Frame: 6 months
Assessed by using enzyme linked immunoassay
6 months
Change in aerobic capacity
Time Frame: 6 months
Assessed by using indirect calorimetry during graded exercise stress test
6 months
Change in systolic and diastolic blood pressure
Time Frame: 6 months
Assessed by using sphygmomanometer
6 months
Change in serum glucose
Time Frame: 6 months
Assessed by glucose oxidase method
6 months
Change in serum insulin
Time Frame: 6 months
Assessed by immunoassay
6 months
Change in serum estradiol
Time Frame: 6 months
Assessed by immunoassay
6 months
Change in 25 hydroxyvitamin D
Time Frame: 6 months
Assessed by immunoassay
6 months
Change in gene expression of muscle anabolic and catabolic factors
Time Frame: 6 months
Assessed by reverse transcription polymerase chain reaction and nanostring
6 months
Change in protein expression of muscle anabolic and catabolic factors
Time Frame: 6 months
Assessed by western blotting
6 months
Change in concentration of targeted metabolites
Time Frame: 6 months
Assessed by liquid chromatography hyphenated with mass spectrometry techniques
6 months
Change in modified mini-mental exam
Time Frame: 6 months
Assessed by using cognitive instrument testing
6 months
Change in word fluency
Time Frame: 6 months
Assessed by using cognitive instrument testing
6 months
Change in trail a and trail b
Time Frame: 6 months
Assessed by using cognitive instrument testing
6 months
Change in Ray Auditory verbal learning test
Time Frame: 6 months
Assessed by using cognitive instrument testing
6 months
Change in muscle protein synthesis rate
Time Frame: 6 months
Assessed by stable isotope methodology
6 months
Change in thigh muscle and fat mass
Time Frame: 6 months
Assessed by magnetic resonance imaging (MRI)
6 months
Change in visceral fat mass
Time Frame: 6 months
Assessed by MRI
6 months
Change in waist circumference
Time Frame: 6 months
Using a tape measure
6 months
Change in serum testosterone
Time Frame: 6 months
Assessed by immunoassay
6 months
Change is serum sclerostin
Time Frame: 6 months
Assessed by immunoassay
6 months
Change in parathyroid hormone
Time Frame: 6 months
Assessed by immunoassay
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biomedical Research Institute of New Mexico

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Baylor College of Medicine
National Institute on Aging (NIA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dennis T Villareal, MD FACP FACE, Baylor College of Medicine

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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 8, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R01AG031176 (U.S. NIH Grant/Contract)

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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