Overview

This trial is active, not recruiting.

Condition obesity
Treatments diet + resistance training, diet + aerobic training, diet + resistance/aerobic exercise
Sponsor Biomedical Research Institute of New Mexico
Collaborator National Institute on Aging (NIA)
Start date February 2010
End date January 2016
Trial size 160 participants
Trial identifier NCT01065636, R01-AG031176, R01AG031176

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
diet + resistance training
Behavioral Therapy through a lifestyle modification program, Diet therapy once weekly through a dietician prescribed diet for 24 weeks, and resistance exercise training 3-days/week for 24 weeks.
(Experimental)
diet + aerobic training
Behavioral Therapy through a lifestyle modification program, Diet therapy once weekly through a dietician prescribed diet for 24 weeks, and aerobic exercise training 3-days/week for 24 weeks
(Experimental)
diet + resistance/aerobic exercise
Behavioral Therapy through a lifestyle modification program, Diet therapy once weekly through a dietician prescribed diet for 24 weeks, and combined resistance/aerobic exercise training 3-days/week for 24 weeks
(No Intervention)

Primary Outcomes

Measure
Physical Function and Body Composition
time frame: 6 Months

Secondary Outcomes

Measure
Bone markers, hormones, muscle cytokines, muscle protein synthesis, cardiometabolic risk factors, cognition, mood, quality of life
time frame: 6 months

Eligibility Criteria

Male or female participants from 65 years up to 85 years old.

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 >1.5mg/dl - No commitments, life situations or conditions that would interfere with their participation in the study

Additional Information

Official title Exercise Interventions During Voluntary Weight Loss in Obese Older Adults
Principal investigator Dennis T Villareal, MD FACP FACE
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by Biomedical Research Institute of New Mexico.