Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Lifestyle Intervention Trial in Obese Elderly (LITOE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01065636
Recruitment Status : Completed
First Posted : February 9, 2010
Last Update Posted : January 22, 2020
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Baylor College of Medicine
Information provided by (Responsible Party):
Dennis Villareal, Baylor College of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Diet + Resistance Training Behavioral: Diet + Aerobic Training Behavioral: Diet + Resistance/Aerobic Exercise Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Exercise Interventions During Voluntary Weight Loss in Obese Older Adults
Study Start Date : February 2010
Actual Primary Completion Date : January 2016
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in lean mass [ Time Frame: 6 months ]
    Assessed using dual energy x-ray absorptiometry (DXA)

  2. Change in fat mass [ Time Frame: 6 months ]
    Assessed using DXA

  3. Change in muscle strength [ Time Frame: 6 months ]
    Assessed using 1-repetition maximum and dynamometry

  4. Change in gait speed [ Time Frame: 6 months ]
    Measured as time to walk a certain distance

  5. Change in areal bone mineral density [ Time Frame: 6 months ]
    Assessed by using DXA

  6. Change in biochemical marker for bone turnover and bone metabolism [ Time Frame: 6 months ]
    Assessed by using enzyme linked immunoabsorbent assay and radioimmunoassay

  7. Change in circulating cytokines [ Time Frame: 6 months ]
    Assessed by using enzyme linked immunoassay

  8. Change in adipocytokines [ Time Frame: 6 months ]
    Assessed by using enzyme linked immunoassay

  9. Change in aerobic capacity [ Time Frame: 6 months ]
    Assessed by using indirect calorimetry during graded exercise stress test

  10. Change in systolic and diastolic blood pressure [ Time Frame: 6 months ]
    Assessed by using sphygmomanometer

  11. Change in serum glucose [ Time Frame: 6 months ]
    Assessed by glucose oxidase method

  12. Change in serum lipids [ Time Frame: 6 months ]
    Assessed by automated enzymatic/colorimetric assays

  13. 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)

  14. Change in habitual physical activity measured objectively [ Time Frame: 6 months ]
    Using accelerometers

  15. Change in serum insulin [ Time Frame: 6 months ]
    Assessed by immunoassay

  16. Change in serum estradiol [ Time Frame: 6 months ]
    Assessed by immunoassay

  17. Change in 25 hydroxyvitamin D [ Time Frame: 6 months ]
    Assessed by immunoassay

  18. Change in Impact of Weight on Quality of Life_Lite (IWQOL-lite) score [ Time Frame: 6 months ]
    Assessed by IWQO-liteL questionnaire

  19. 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)

  20. Change in gene expression of muscle anabolic and catabolic factors [ Time Frame: 6 months ]
    Assessed by reverse transcription polymerase chain reaction and nanostring

  21. Change in protein expression of muscle anabolic and catabolic factors [ Time Frame: 6 months ]
    Assessed by western blotting

  22. Change in concentration of targeted metabolites [ Time Frame: 6 months ]
    Assessed by liquid chromatography hyphenated with mass spectrometry techniques

  23. Change in dynamic balance [ Time Frame: 6 months ]
    Assessed by the obstacle course

  24. Change in static balance [ Time Frame: 6 months ]
    Assessed by one leg stance

  25. Change in modified mini-mental exam [ Time Frame: 6 months ]
    Assessed by using cognitive instrument testing

  26. Change in word fluency [ Time Frame: 6 months ]
    Assessed by using cognitive instrument testing

  27. Change in trail a and trail b [ Time Frame: 6 months ]
    Assessed by using cognitive instrument testing

  28. Change in Ray Auditory verbal learning test [ Time Frame: 6 months ]
    Assessed by using cognitive instrument testing

  29. Change in muscle protein synthesis rate [ Time Frame: 6 months ]
    Assessed by stable isotope methodology

  30. Change in thigh muscle and fat mass [ Time Frame: 6 months ]
    Assessed by magnetic resonance imaging (MRI)

  31. Change in visceral fat mass [ Time Frame: 6 months ]
    Assessed by MRI

  32. Change in mood [ Time Frame: 6 months ]
    Assessed by geriatric depression scale (score range: 0 to 30, where lower scores indicating better mood)

  33. Change in waist circumference [ Time Frame: 6 months ]
    Using a tape measure

  34. Change in serum testosterone [ Time Frame: 6 months ]
    Assessed by immunoassay

  35. 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)

  36. Change is serum sclerostin [ Time Frame: 6 months ]
    Assessed by immunoassay

  37. Change in parathyroid hormone [ Time Frame: 6 months ]
    Assessed by immunoassay



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01065636


Locations
Layout table for location information
United States, New Mexico
New Mexico VA Medical Center and University of New Mexico School of Medicine
Albuquerque, New Mexico, United States, 87108
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Biomedical Research Institute of New Mexico
National Institute on Aging (NIA)
Baylor College of Medicine
Investigators
Layout table for investigator information
Principal Investigator: Dennis T Villareal, MD FACP FACE Baylor College of Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Dennis Villareal, Professor of Medicine, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01065636    
Other Study ID Numbers: R01AG031176 ( U.S. NIH Grant/Contract )
R01AG031176 ( U.S. NIH Grant/Contract )
First Posted: February 9, 2010    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020