Lifestyle Intervention Trial in Obese Elderly (LITOE)
This study is currently recruiting participants.
Verified July 2011 by Biomedical Research Institute of New Mexico
Sponsor:
Biomedical Research Institute of New Mexico
Collaborator:
Information provided by:
Biomedical Research Institute of New Mexico
ClinicalTrials.gov Identifier:
NCT01065636
First received: February 8, 2010
Last updated: July 21, 2011
Last verified: July 2011
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Purpose
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 | Intervention |
|---|---|
|
Obesity |
Behavioral: Diet + Resistance Training Behavioral: Diet + Aerobic Training Behavioral: Diet + Resistance/Aerobic Exercise Behavioral: Control group |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Exercise Interventions During Voluntary Weight Loss in Obese Older Adults |
Resource links provided by NLM:
Further study details as provided by Biomedical Research Institute of New Mexico:
Primary Outcome Measures:
- Physical Function and Body Composition [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Bone markers, hormones, muscle cytokines, muscle protein synthesis, cognition, mood, quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 160 |
| Study Start Date: | February 2010 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Diet + Resistance Exercise Training |
Behavioral: 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 Exercise Training |
Behavioral: 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 + Combined Aerobic/Resistance Exercise |
Behavioral: 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: Control Group (No Diet/No Exercise) |
Behavioral: Control group
No intervention - comparison group
|
Eligibility| Ages Eligible for Study: | 65 Years to 85 Years |
| Genders Eligible for Study: | Both |
| 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 >1.5mg/dl
- No commitments, life situations or conditions that would interfere with their participation in the study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01065636
Contacts
| Contact: Sheryl Pascual, MD | 505-222-3616 | sheryl.pascual@va.gov |
Locations
| United States, New Mexico | |
| New Mexico VA Medical Center and University of New Mexico School of Medicine | Recruiting |
| Albuquerque, New Mexico, United States, 87108 | |
| Contact: Sheryl Pascual 505-265-1711 ext 3616 sheryl.pascual@va.gov | |
Sponsors and Collaborators
Biomedical Research Institute of New Mexico
Investigators
| Principal Investigator: | Dennis T Villareal, MD FACP FACE | New Mexico VA Health Care System/University of New Mexico School of Medicine |
More Information
No publications provided
| Responsible Party: | Dennis Villareal M.D. Chief of Geriatrics, New Mexico VA Healthcare System/University of New Mexico School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01065636 History of Changes |
| Other Study ID Numbers: | R01-AG031176, R01AG031176 |
| Study First Received: | February 8, 2010 |
| Last Updated: | July 21, 2011 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 21, 2013