Investigating Fitness Interventions in the Elderly (INFINITE) (INFINITE)

July 30, 2018 updated by: Wake Forest University Health Sciences
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Design Overview:

Phase 1 involves recruitment and screening followed by baseline research testing (Phase 2). Next, subjects will be randomly assigned to one of three 5-month treatments (Phase 3): exercise and high-caloric restriction diet, exercise and low-caloric restriction diet, or exercise only. Subjects will complete follow-up testing after their 5 month intervention.

Interventions:

Dietary interventions: All participants will be randomly assigned to an exercise intervention with either no dietary intervention (EX Only), or 1 of 2 hypocaloric controlled diets: 1) -250 kcal/day deficit for low fat loss (EX+LOW CR) or 2) -600 kcal/day deficit for high fat loss (EX+HIGH CR) for 20 weeks.

All meals are prepared individually after participants choose from a hypocaloric menu designed by the RD to provide a balanced, healthy diet. The calorie level assigned for each person will provide him/her with an absolute daily caloric deficit consistent with their group assignment (-600 or -250 kcals/day). Individual calorie levels will be prescribed to provide calorie levels to the nearest 50 kcals (e.g., 1100 kcal, 1150 kcal, 1200 kcal, etc.). They are educated by the GCRC RDs and provided menus to guide their food purchasing and preparation of daily breakfast meals that are consistent with the prescribed calorie level. They are asked to consume only the food that is given to them or that is approved from the breakfast menu. All participants will pick up their food 3 times/wk during the intervention, and are asked to keep a log of everything they eat or drink.

Exercise intervention: The exercise will take place in an exercise facility at the Geriatric Research Center on the campus of the Wake Forest University/Baptist Medical Center. Two study personnel, including at least one trained technician, will supervise all exercise sessions. Emergency equipment will be kept on site during exercise sessions. Blood pressure and heart rate (HR) will be measured before each exercise session and subjects will warm-up by walking for 3-5 min at a slow pace and will then walk at an intensity of 65-70% of heart rate reserve (HRR, assessed during the VO2max test). The duration of walking exercise will progress from 15-20 mins at 50% HRR the 1st week to 30 mins at 65-70% HRR by the end of the 6th week and thereafter. Each walking session will end with a 3-5 min cool-down followed by 5 min of large muscle flexibility exercise.

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 80 years (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Exercise
All treatment groups will receive 4d/wk of exercise
Behavioral: Exercise Only
4 d/wk of aerobic exercise
Other Names:
  • EX
EXPERIMENTAL: Exercise + Diet (-250 kcal/d deficit)
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 4d/wk with moderate caloric restriction (-250 kcal/d deficit) designed for low fat loss (EX+Low CR; ~4.5 kg weight loss).
Other Names:
  • EX+Low CR
Behavioral: Exercise + Diet
Exercise 4d/wk with intensive caloric restriction (-600 kcal/d deficit) designed for high fat loss (EX+High CR; ~10.9 kg weight loss)
Other Names:
  • EX+ High CR
EXPERIMENTAL: Exercise + Diet (-600 kcal/d deficit)
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
Exercise 4d/wk with moderate caloric restriction (-250 kcal/d deficit) designed for low fat loss (EX+Low CR; ~4.5 kg weight loss).
Other Names:
  • EX+Low CR
Behavioral: Exercise + Diet
Exercise 4d/wk with intensive caloric restriction (-600 kcal/d deficit) designed for high fat loss (EX+High CR; ~10.9 kg weight loss)
Other Names:
  • EX+ High CR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
maximal aerobic capacity (VO2max) and functional endurance (400 m walk time)
Time Frame: assessment visits will take place at baseline and post 5 months intervention
assessment visits will take place at baseline and post 5 months intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
changes in specific CVD risk factors (inflammatory markers, blood lipids, blood pressure, and glucose tolerance)
Time Frame: baseline and 5-month follow-up
baseline and 5-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (ACTUAL)

September 1, 2014

Study Completion (ACTUAL)

September 1, 2014

Study Registration Dates

First Submitted

January 11, 2010

First Submitted That Met QC Criteria

January 13, 2010

First Posted (ESTIMATE)

January 14, 2010

Study Record Updates

Last Update Posted (ACTUAL)

August 1, 2018

Last Update Submitted That Met QC Criteria

July 30, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00008292

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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