Lifestyle Intervention Trial in Obese Elderly (LITOE)

Biomedical Research Institute of New Mexico

Status: Completed

Conditions: Obesity

Treatments: Behavioral: Diet + Aerobic Training; Behavioral: Diet + Resistance Training; Behavioral: Diet + Resistance/Aerobic Exercise

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01065636

R01AG031176 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: All

Ages: 65 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 4 patient groups

Diet + Resistance Exercise Training

Experimental group

Description:

Weekly behavioral/diet-induced weight loss plus supervised resistance exercise training three times a week

Treatment:

Behavioral: Diet + Resistance Training

Diet + Aerobic Exercise Training

Experimental group

Description:

Weekly behavioral/diet-induced weight loss plus supervised aerobic exercise training three times a week

Treatment:

Behavioral: Diet + Aerobic Training

Diet + Combined Aerobic/Resistance Exercise

Experimental group

Description:

Weekly behavioral/diet-induced weight loss plus combined supervised resistance exercise training and aerobic exercise training three times a week

Treatment:

Behavioral: Diet + Resistance/Aerobic Exercise

Control Group (No Diet/No Exercise)

No Intervention group

Description:

No diet No exercise training