Activity, Gait, and Efficacy (AGE II): Functional Limitations and Quality of Life (AGE II)

February 21, 2017 updated by: Edward McAuley, University of Illinois at Urbana-Champaign

The purpose of this study is to test the effectiveness of a DVD-delivered, home-based, six-month physical activity intervention for older adults.

A comparative effectiveness study of the FlexToBa DVD exercise program will be conducted in 2014.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This program compares progressive strength, flexibility, toning and balance (FlexToBa) activities delivered via home-based DVD intervention compared to an attention control group to determine the program's effects on functional limitations, functional performance in everyday activities, balance, and quality of life (QOL) in sedentary older adults over 65 years of age. The principals of REAIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) will be implemented into the design and evaluation of the program in order to determine the generalizable cost-effectiveness and potential public health impact of delivering physical activity to older adults via DVD media. Measurements assessed at baseline, six months, and 12 months include: functional performance and functional limitations, self-efficacy, physical activity, and measures of health status and well-being. We propose to recruit and randomly assign 250 older (65+) adults from across Central Illinois to the FlexToBa condition or to an attention control condition. The former will receive the activity program DVD and the latter will receive a healthy aging DVD (with no physical activity instruction). The control group will be offered the FlexToBa program following 6-month follow-up assessments. The health relevance of this project is considerable as it targets a population that is largely sedentary and suffers from unprecedented levels of functional limitations, factors that have significant implications for compromised quality of life and independent living. By adopting broad recruitment strategies with few exclusionary criteria, we will be able to effectively improve the physical activity behavior of a diverse class of older adults. Offering this as a DVD-based physical activity program will provide a convenient opportunity for older adults to become and stay physically active. We intend to provide a limited number of DVD players to those interested participants who do not already own one.

In 2014, investigators will study the comparative effectiveness of the FlexToBa DVD trial as compared to a DVD-only intervention.Researchers will provide the exercise DVD to an entire wave/group of participants with half receiving the motivational telephone calls and feedback (as with earlier waves) and the other half receiving no motivational communications.

The procedures for the Support Group, who receive the motivational support, will be identical to earlier waves. Both groups will receive the FlexToBa DVDs and equipment at the initial testing and orientation meeting but the Effectiveness Group will not receive the motivational feedback. Testing at month six is identical to earlier waves and both groups will be asked to evaluate the program at the end of the intervention.

There is no plan for follow-up testing at month 12 or month 24 for this wave of participants.

Study Type

Interventional

Enrollment (Actual)

410

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
    • Illinois
      • Urbana, Illinois, United States, 61801
        • University of Illinois at Urbana-Champaign

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 85 years (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • being non-active, defined as reporting not engaging in regular activity (30 minutes accumulated per day) on more than two days of the week in the prior six months;
  • aged 65 - 85 years;
  • capable of participation in a program of flexibility,
  • toning and balance without exacerbating any pre-existing conditions;
  • able to obtain medical clearance for physical activity.

Exclusion Criteria:

  • self-reported physical activity on a regular basis within the last six months (2 times or more per week);
  • any physical disability that strictly prohibits stretching, strengthening and balance exercises;
  • no regular access to a television;
  • unable to successfully answer 21 out of 39 questions on the Telephone Interview of Cognitive Status questionnaire (TICS-M).

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FlexToBa physical activity DVD
Participants in this arm will receive a physical activity program delivered by DVD that focuses on exercises targeting flexibility, toning and balance. These exercises will be progressive in nature throughout the six months and will also focus on modifications for all ability levels. Participants will be provided with three DVDs including: an Introduction to physical activity, Sessions 1-3, and Sessions 4-6, which they will be asked to watch and participate in over the course of six months.
Behavioral: Home-based, DVD-delivered physical activity
Subjects will be participating in a home-based physical activity program that focuses on flexibility, toning and balance. Exercises will be progressive over the six-months and will highlight modifications for varying levels. This program will be delivered on 3 DVDs. Participants will be asked to exercise with the DVD at least three times per week. Additionally, they will be encouraged to add two days of aerobic activity (e.g. walking) each week.
Placebo Comparator: Usual care-Wait list
Participants in this arm will receive a DVD that focuses on healthy aging topics but does not include physical activity. They will receive the FlexToBa DVD after the completion of the 12-month follow-up testing.
Behavioral: Usual care/Wait list
Participants in this arm will receive a DVD that focuses on healthy aging topics but does not include physical activity. They will receive the FlexToBa DVD afer the completion of the 12-month follow-up testing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Functional performance, balance and reduced self-reported upper and lower body functional limitations in sedentary, older adults' physical activity.
Time Frame: Baseline, 6-month, 12-month follow-up
Baseline, 6-month, 12-month follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of Life
Time Frame: Baseline, 6-month, 12-month follow-up
Baseline, 6-month, 12-month follow-up
Self-efficacy
Time Frame: Baseline, six-months, and 12-month folluw-up
Baseline, six-months, and 12-month folluw-up
REAIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) to determine the impact of delivering physical activity via DVD media
Time Frame: Baseline, 6-months, 12-month follow-up
Baseline, 6-months, 12-month follow-up
Adherence
Time Frame: Baseline, 6-months, 12-month follow-up
Baseline, 6-months, 12-month follow-up

Collaborators and Investigators

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

Sponsor

University of Illinois at Urbana-Champaign

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Edward McAuley, PhD, University of Illinois at Urbana-Champaign

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

February 1, 2010

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

December 10, 2009

First Submitted That Met QC Criteria

December 10, 2009

First Posted (Estimate)

December 11, 2009

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 21, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UIUC_IRB_09765
  • 2R01AG020118-05A2 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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