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Completed

NCT Number: NCT01065636

Lifestyle Intervention Trial in Obese Elderly

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New Mexico VA Medical Center and University of New Mexico School of Medicine, Albuquerque, New Mexico, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet + Resistance Training

Behavioral

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.

Diet + Aerobic Training

Behavioral

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

Diet + Resistance/Aerobic Exercise

Behavioral

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Biomedical Research Institute of New Mexico

Other

Collaborators

  • Baylor College of Medicine
  • National Institute on Aging (NIA)

Registry information

Official study title

Exercise Interventions During Voluntary Weight Loss in Obese Older Adults

Acronym: LITOE

Important dates

Study start
2010
Primary completion
2016
Study completion
2018
First posted
Feb 9, 2010
Registry last updated
Jan 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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