NCT01030419

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
410

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 11, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

4.8 years

First QC Date

December 10, 2009

Last Update Submit

February 21, 2017

Conditions

Aging

Keywords

AgingQuality of LifeFunctional fitness

Outcome Measures

Primary Outcomes (1)

  • Functional performance, balance and reduced self-reported upper and lower body functional limitations in sedentary, older adults' physical activity.

    Baseline, 6-month, 12-month follow-up

Secondary Outcomes (4)

  • Quality of Life

    Baseline, 6-month, 12-month follow-up

  • Self-efficacy

    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

    Baseline, 6-months, 12-month follow-up

  • Adherence

    Baseline, 6-months, 12-month follow-up

Study Arms (2)

FlexToBa physical activity DVD

EXPERIMENTAL

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

Usual care-Wait list

PLACEBO COMPARATOR

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

Interventions

Home-based, DVD-delivered physical activityBEHAVIORAL

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.

FlexToBa physical activity DVD
Usual care/Wait listBEHAVIORAL

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.

Usual care-Wait list

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

Location

Related Publications (6)

  • Salerno EA, Gothe NP, Fanning J, Peterson LL, Colditz GA, McAuley E. Effects of a DVD-delivered randomized controlled physical activity intervention on functional health in cancer survivors. BMC Cancer. 2021 Jul 29;21(1):870. doi: 10.1186/s12885-021-08608-8.

    PMID: 34325676DERIVED

  • Aguinaga S, Ehlers DK, Salerno EA, Fanning J, Motl RW, McAuley E. Home-Based Physical Activity Program Improves Depression and Anxiety in Older Adults. J Phys Act Health. 2018 Sep 1;15(9):692-696. doi: 10.1123/jpah.2017-0390. Epub 2018 Apr 6.

    PMID: 29625012DERIVED

  • Awick EA, Ehlers D, Fanning J, Phillips SM, Wojcicki T, Mackenzie MJ, Motl R, McAuley E. Effects of a Home-Based DVD-Delivered Physical Activity Program on Self-Esteem in Older Adults: Results From a Randomized Controlled Trial. Psychosom Med. 2017 Jan;79(1):71-80. doi: 10.1097/PSY.0000000000000358.

    PMID: 27359182DERIVED

  • Roberts S, Awick E, Fanning JT, Ehlers D, Motl RW, McAuley E. Long-Term Maintenance of Physical Function in Older Adults Following a DVD-Delivered Exercise Intervention. J Aging Phys Act. 2017 Jan;25(1):27-31. doi: 10.1123/japa.2015-0284. Epub 2016 Aug 24.

    PMID: 27180818DERIVED

  • Fanning J, Awick EA, Wojcicki TR, Gothe N, Roberts S, Ehlers DK, Motl RW, McAuley E. Effects of a DVD-Delivered Exercise Intervention on Maintenance of Physical Activity in Older Adults. J Phys Act Health. 2016 Jun;13(6):594-8. doi: 10.1123/jpah.2015-0173. Epub 2015 Nov 23.

    PMID: 26595937DERIVED

  • McAuley E, Wojcicki TR, White SM, Mailey EL, Szabo AN, Gothe N, Olson EA, Mullen SP, Fanning J, Motl RW, Rosengren K, Estabrooks P. Physical activity, function, and quality of life: design and methods of the FlexToBa trial. Contemp Clin Trials. 2012 Jan;33(1):228-36. doi: 10.1016/j.cct.2011.10.002. Epub 2011 Oct 17.

    PMID: 22024470DERIVED

Study Officials

  • Edward McAuley, PhD

    University of Illinois at Urbana-Champaign

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Kinesiology and Community Health

Study Record Dates

First Submitted

December 10, 2009

First Posted

December 11, 2009

Study Start

February 1, 2010

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

February 23, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)