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Clinical Trials/NCT01065636
NCT01065636
Completed
N/A

Exercise Interventions During Voluntary Weight Loss in Obese Older Adults

Biomedical Research Institute of New Mexico2 sites in 1 country160 target enrollmentFebruary 2010
ConditionsObesity

Overview

Phase
N/A
Intervention
Not specified
Conditions
Obesity
Sponsor
Biomedical Research Institute of New Mexico
Enrollment
160
Locations
2
Primary Endpoint
Change in Physical Function
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2010
End Date
December 31, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dennis Villareal

Professor of Medicine

Baylor College of Medicine

Eligibility 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

Outcomes

Primary Outcomes

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

  • Change is serum sclerostin(6 months)
  • Change in adipocytokines(6 months)
  • Change in 25 hydroxyvitamin D(6 months)
  • Change in Impact of Weight on Quality of Life_Lite (IWQOL-lite) score(6 months)
  • Change in dynamic balance(6 months)
  • Change in word fluency(6 months)
  • Change in trail a and trail b(6 months)
  • Change in fat mass(6 months)
  • Change in muscle strength(6 months)
  • Change in areal bone mineral density(6 months)
  • Change in aerobic capacity(6 months)
  • Change in serum insulin(6 months)
  • Change in Medical Outcomes 36-Item short form Health survey (SF-36)(6 months)
  • Change in gene expression of muscle anabolic and catabolic factors(6 months)
  • Change in visceral fat mass(6 months)
  • Change in gait speed(6 months)
  • Change in biochemical marker for bone turnover and bone metabolism(6 months)
  • Change in serum glucose(6 months)
  • Change in serum lipids(6 months)
  • Change in serum estradiol(6 months)
  • Change in lean mass(6 months)
  • Change in circulating cytokines(6 months)
  • Change in systolic and diastolic blood pressure(6 months)
  • Change in protein expression of muscle anabolic and catabolic factors(6 months)
  • Change in habitual physical activity assessed by questionnaires(6 months)
  • Change in habitual physical activity measured objectively(6 months)
  • Change in concentration of targeted metabolites(6 months)
  • Change in static balance(6 months)
  • Change in modified mini-mental exam(6 months)
  • Change in Ray Auditory verbal learning test(6 months)
  • Change in muscle protein synthesis rate(6 months)
  • Change in serum testosterone(6 months)
  • Change in thigh muscle and fat mass(6 months)
  • Change in subjective ability to function(6 months)
  • Change in mood(6 months)
  • Change in waist circumference(6 months)
  • Change in parathyroid hormone(6 months)

Study Sites (2)

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