Investigating Fitness Interventions in the Elderly (INFINITE)

NCT01048736 | Completed DMC

• 2 other identifiers: IRB0000829240010566
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Older Adults; Sedentary

Keywords

obesity; exercise; intensity; weight loss; diet

Outcome Measures

Primary Outcomes (1)

• maximal aerobic capacity (VO2max) and functional endurance (400 m walk time)

  assessment visits will take place at baseline and post 5 months intervention

Secondary Outcomes (1)

• changes in specific CVD risk factors (inflammatory markers, blood lipids, blood pressure, and glucose tolerance)

  baseline and 5-month follow-up

Study Arms (3)

Exercise

ACTIVE COMPARATOR

All treatment groups will receive 4d/wk of exercise

Behavioral: Exercise Only

Exercise + Diet (-250 kcal/d deficit)

EXPERIMENTAL

Exercise 4d/wk with moderate caloric restriction (-250 kcal/d deficit) designed for low fat loss (EX+Low CR; \~4.5 kg weight loss),

Behavioral: Exercise + Diet

Exercise + Diet (-600 kcal/d deficit)

EXPERIMENTAL

Exercise 4d/wk with intensive caloric restriction (-600 kcal/d deficit) designed for high fat loss (EX+High CR; \~10.9 kg weight loss)

Behavioral: Exercise + Diet

Interventions

Exercise Only BEHAVIORAL

4 d/wk of aerobic exercise

Also known as: EX

Exercise

Exercise + Diet BEHAVIORAL

Exercise 4d/wk with moderate caloric restriction (-250 kcal/d deficit) designed for low fat loss (EX+Low CR; \~4.5 kg weight loss).

Also known as: EX+Low CR

Exercise + Diet (-250 kcal/d deficit)

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University

Winston-Salem, North Carolina, United States

Location

Related Publications (1)

• Brinkley TE, Leng I, Bailey MJ, Houston DK, Hugenschmidt CE, Nicklas BJ, Hundley WG. Effects of Exercise and Weight Loss on Proximal Aortic Stiffness in Older Adults With Obesity. Circulation. 2021 Aug 31;144(9):684-693. doi: 10.1161/CIRCULATIONAHA.120.051943. Epub 2021 Aug 2.

  PMID: 34333991 DERIVED

MeSH Terms

Conditions

Obesity; Sedentary Behavior; Motor Activity; Weight Loss

Interventions

Exercise; Diet

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Body Weight Changes

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2010
• First Posted: January 14, 2010
• Study Start: October 1, 2009
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: January 20, 2026

Record last verified: 2018-07

Locations

US (1)