AgingAGE IINCT01030419
Activity, Gait, and Efficacy (AGE II): Functional Limitations and Quality of Life
A study testing Home-based, DVD-delivered physical activity in people with Aging, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Home-based, DVD-delivered physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 410 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Urbana-Champaign
Urbana, Illinois, 61801
About this study
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.
Read the 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.
- Conditions
- Aging
- Being tested
- Home-based, DVD-delivered physical activity, Usual care/Wait list
- Keywords
- Aging, Quality of Life, Functional fitness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based, DVD-delivered physical activityBehavioural
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.
Usual care/Wait listBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Usual care/Wait list |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional performance, balance and reduced self-reported upper and lower body functional limitations in sedentary, older adults' physical activity.
Measured: Baseline, 6-month, 12-month follow-up
Secondary outcomes (4)
Quality of Life
Measured: Baseline, 6-month, 12-month follow-up
Self-efficacy
Measured: 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
Measured: Baseline, 6-months, 12-month follow-up
Adherence
Measured: Baseline, 6-months, 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2009 (estimated)
- Study startFeb 2010
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Edward McAuley, University of Illinois at Urbana-Champaign
- Investigators
- Edward McAuley, PhD, Principal investigator, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01030419
- Sponsor's protocol ID
- UIUC_IRB_09765
- Other IDs
- 2R01AG020118-05A2
- Acronym
- AGE II
- Status last verified
- Feb 2017
- First submitted
- 10 Dec 2009
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 34325676Aguinaga 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.
PubMed 29625012Awick 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.
PubMed 27359182Roberts 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.
PubMed 27180818Fanning 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.
PubMed 26595937McAuley 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.
PubMed 22024470
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activity, Gait, and Efficacy (AGE II): Functional Limitations and Quality of Life
- ClinicalTrials.gov ID
- NCT01030419
- Acronym / sponsor ID
- AGE II / UIUC_IRB_09765
- Conditions
- Aging
- Keywords
- Aging, Quality of Life, Functional fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 410 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Feb 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FlexToBa physical activity DVD | Experimental | Behavioral: Home-based, DVD-delivered physical activityParticipants 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. |
| Usual care-Wait list | Placebo comparator | Behavioral: Usual care/Wait listParticipants 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. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based, DVD-delivered physical activitySubjects 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. | Behavioural | FlexToBa physical activity DVD |
| Usual care/Wait listParticipants 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. | Behavioural | Usual care-Wait list |
Primary outcome
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
4 secondary outcomes
Quality of Life
Time frame: Baseline, 6-month, 12-month follow-up
Self-efficacy
Time frame: 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
Adherence
Time frame: Baseline, 6-months, 12-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Derived from this study: PubMed 34325676Salerno 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.
- Derived from this study: PubMed 29625012Aguinaga 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.
- Derived from this study: PubMed 27359182Awick 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.
- Derived from this study: PubMed 27180818Roberts 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.
- Derived from this study: PubMed 26595937Fanning 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.
- Derived from this study: PubMed 22024470McAuley 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward McAuley, PhD principal investigator
University of Illinois at Urbana-Champaign
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based, DVD-delivered physical activity in people with Aging, run by University of Illinois at Urbana-Champaign at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01030419, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.