Investigating Fitness Interventions in the Elderly (INFINITE)

Completed · Not applicable

Conditions studied: Obesity, Older Adults, Sedentary

In brief

Aging is associated with declines in aerobic capacity, exercise tolerance, and functional endurance that lead to physical disability and loss of independence. Furthermore, the existing high prevalence of obesity in the elderly is greatly exacerbating these aging-related declines in function. To date, regular exercise is the only known therapy to consistently improve aerobic function, and perhaps delay the onset of disability. Although aerobic exercise training does benefit both aerobic capacity and endurance even in obese persons, some data show that the maximal efficacy of exercise for improving aerobic function is blunted by obesity. In addition, our preliminary data show a potential dose-response benefit of concomitant fat loss on exercise-induced improvements in aerobic function. Thus, combining an exercise intervention with caloric restriction resulting in fat loss may be more efficacious for improving aerobic function than exercise alone in obese elderly, a population at high risk for disability. The purpose of this study is to determine whether the amount of fat loss (achieved through controlled underfeeding) affects the magnitude of improvement in aerobic function (maximal aerobic capacity and endurance) in response to a standardized exercise training stimulus that follows current recommendations for older persons.

Key facts

Study ID

NCT01048736

Run by

Wake Forest University Health Sciences

People needed

180

Starts

2009-10-01

Expected to finish

2014-09-01

Last updated by the study team

2026-01-20

Who can join

Age: 65 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• BMI=30-34.9 kg/m2
• Sedentary for past 6 months (<30 min, 3 d/wk of exercise, including walking)
• Normal cognitive function (MMSE >24)
• No contraindications for participation in weight loss or exercise (e.g., severe arthritis or musculoskeletal disorders)
• Able to provide own transportation to study visits and intervention
• No drug abuse or excessive alcohol use (> 7 drinks/week)
• Not dependent on a cane or walker

You may not qualify if…

• Weight loss or gain (±5%) in past 6 months
• Body weight >136.4 kg (DXA limit is 300 lbs)
• Smoker (No nicotine within past year)
• Osteoporosis (T-score ≥ -2.5)
• Abnormal kidney function tests
• Insulin-dependent or uncontrolled diabetes
• Uncontrolled hypertension (BP>200/110 mmHg)
• Hypertriglyceridemia (TG>400 mg/dl)
• Past or current ischemic heart disease, angina, heart failure, peripheral artery disease, stroke, chronic respiratory disease, uncontrolled endocrine/metabolic disease, neurological or hematological disease, clinically evident edema
• Cancer requiring treatment in past 2 years, except non-melanoma skin cancers
• Severe anemia (Hb<10 g/100 ml)
• Hip fracture, hip or knee replacement, or spinal surgery in past 6 months
• Regular use of medications that influence study variables (growth/steroid hormones, estrogen, anti-inflammatory, beta blockers, etc.

Where it is running

• Wake Forest University — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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