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Dose Response Study of Aerobic Exercise in Older Adults

NCT01129115 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2016-02-15

Study results available
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Summary

This is a randomized, 26-week study of supervised exercise assessing three doses of exercise in sedentary individuals 65 years of age and over with age-related cognitive changes. A total of 100 subjects (n=25 in each of four groups) will be randomized to a non-aerobic control group, 75 minutes, 150 minutes, or 225 minutes a week of moderate intensity aerobic exercise spread over 3 to 5 days a week for 26 weeks. These exercise doses represent 50%, 100%, or 150% of the recommended exercise dose. Participants will be directly supervised during all exercise sessions for the first two months after which direct supervision will occur during at least one session a week. This is intended to provide increased flexibility while also maintaining direct contact with the participant to enhance adherence. Aerobic fitness, physical function, and cognition will be assessed at baseline and 26 weeks to examine the dose-response relationships.

Conditions

Interventions

BEHAVIORAL

Nonexercise control group

Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.

BEHAVIORAL

Aerobic Exercise Group 1

The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.

BEHAVIORAL

Aerobic Exercise Group 2

The 100% group will perform 150 minutes a week of exercise over 3 - 5 days

BEHAVIORAL

Aerobic Exercise Group 3

The 150% group will perform 225 minutes a week of exercise over 4 - 5 days.

Sponsors & Collaborators

  • Jeff Burns, MD

    lead OTHER

Principal Investigators

  • Jeffrey Burns, MD · University of Kansas Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2014-02-28
Completion
2014-04-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01129115 on ClinicalTrials.gov