AgingPhase 3NCT00097643
Problem Solving/Physical Interventions and Aging
A Phase 3 study testing exercise and health promotion in people with Aging, run by National Institute on Aging (NIA).
Trial summary
The purpose of this study is to examine the relative and combined efficacy of a physical activity and health promotion program to help sedentary adults over age 70 maintain an independent life style. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- exercise and health promotion
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 273 participants
- Where
- No sites listed yet
- Study dates
- Sep 2000to Sep 2004
- Phase
- Phase 3
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- age 70 or older
- live independently
- less than 150 minutes regular exercise per week
- able to walk across a room without a person assisting
- English speaking
- planning to stay in local area for at least 6 months (duration of active study)
Who cannot join
- cancer
- heart attack
- stroke
- uncontrolled arrhythmia
- uncontrolled hypertension
- uncontrolled diabetes
- surgery during the past year
- ongoing mental health or psychiatric condition
About this study
The purpose of this study is to examine the relative and combined efficacy of a physical activity and health promotion program to help sedentary adults over age 70 maintain an independent life style.
Read the detailed description
The study recruited 273 participants from a community-based HMO for whom computerized health service utilization and cost data were already available, as well as cognitive, functional, and health status measures. The participants were randomly placed into one of four treatment groups: exercise, health promotion, combination exercise and health promotion, and routine medical care. Assessments for physical performance, emotional well-being, and physical and emotional health status were conducted at screening, baseline, after 3 months (post-treatment), and at 6, 12, and 18-month follow-up by interviewers blind to treatment assignment.
- Conditions
- Aging
- Being tested
- exercise, health promotion
- Keywords
- exercise, health promotion, independent living, affective aspects
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseBehavioural
health promotionBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
physical health and function
Measured: screening, baseline, 3, 6, 12, and 18 months
affective status
Measured: screening, baseline, 3, 6, 12, and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2004 (estimated)
- Study startSep 2000
- Primary completionSep 2004
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Enrolment
- 273 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Linda Teri, PhD, Principal investigator, University of Washington School of Nursing, Northwest Research Group on Aging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00097643
- Sponsor's protocol ID
- AG0009
- Other IDs
- 5R01AG014777-05
- Status last verified
- Aug 2008
- First submitted
- 24 Nov 2004
- Last updated
- 13 Aug 2008
- Results posted
- No
Publications
Seeman TE, Charpentier PA, Berkman LF, Tinetti ME, Guralnik JM, Albert M, Blazer D, Rowe JW. Predicting changes in physical performance in a high-functioning elderly cohort: MacArthur studies of successful aging. J Gerontol. 1994 May;49(3):M97-108. doi: 10.1093/geronj/49.3.m97.
PubMed 8169338Schulz R, Heckhausen J. A life span model of successful aging. Am Psychol. 1996 Jul;51(7):702-14. doi: 10.1037//0003-066x.51.7.702.
PubMed 8694390Strawbridge WJ, Cohen RD, Shema SJ, Kaplan GA. Successful aging: predictors and associated activities. Am J Epidemiol. 1996 Jul 15;144(2):135-41. doi: 10.1093/oxfordjournals.aje.a008900.
PubMed 8678044Stuck AE, Walthert JM, Nikolaus T, Bula CJ, Hohmann C, Beck JC. Risk factors for functional status decline in community-living elderly people: a systematic literature review. Soc Sci Med. 1999 Feb;48(4):445-69. doi: 10.1016/s0277-9536(98)00370-0.
PubMed 10075171King AC, Pruitt LA, Phillips W, Oka R, Rodenburg A, Haskell WL. Comparative effects of two physical activity programs on measured and perceived physical functioning and other health-related quality of life outcomes in older adults. J Gerontol A Biol Sci Med Sci. 2000 Feb;55(2):M74-83. doi: 10.1093/gerona/55.2.m74.
PubMed 10737689Nelson ME, Layne JE, Bernstein MJ, Nuernberger A, Castaneda C, Kaliton D, Hausdorff J, Judge JO, Buchner DM, Roubenoff R, Fiatarone Singh MA. The effects of multidimensional home-based exercise on functional performance in elderly people. J Gerontol A Biol Sci Med Sci. 2004 Feb;59(2):154-60. doi: 10.1093/gerona/59.2.m154.
PubMed 14999030Strawbridge WJ, Deleger S, Roberts RE, Kaplan GA. Physical activity reduces the risk of subsequent depression for older adults. Am J Epidemiol. 2002 Aug 15;156(4):328-34. doi: 10.1093/aje/kwf047.
PubMed 12181102
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Problem Solving/Physical Interventions and Aging
- ClinicalTrials.gov ID
- NCT00097643
- Acronym / sponsor ID
- AG0009
- Conditions
- Aging
- Keywords
- exercise, health promotion, independent living, affective aspects
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 273 participants
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- Sep 2000
- Primary completion
- Sep 2004 (actual)
- Study completion
- Sep 2004 (actual)
- First posted
- 25 Nov 2004 (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 examine the relative and combined efficacy of a physical activity and health promotion program to help sedentary adults over age 70 maintain an independent life style.
Detailed description
The study recruited 273 participants from a community-based HMO for whom computerized health service utilization and cost data were already available, as well as cognitive, functional, and health status measures. The participants were randomly placed into one of four treatment groups: exercise, health promotion, combination exercise and health promotion, and routine medical care. Assessments for physical performance, emotional well-being, and physical and emotional health status were conducted at screening, baseline, after 3 months (post-treatment), and at 6, 12, and 18-month follow-up by interviewers blind to treatment assignment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- age 70 or older
- live independently
- less than 150 minutes regular exercise per week
- able to walk across a room without a person assisting
- English speaking
Key exclusion criteria (8 listed)
- cancer
- heart attack
- stroke
- uncontrolled arrhythmia
- uncontrolled hypertension
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 |
|---|---|---|
| exercise | Behavioural | – |
| health promotion | Behavioural | – |
Primary outcome
physical health and function
Time frame: screening, baseline, 3, 6, 12, and 18 months
affective status
Time frame: screening, baseline, 3, 6, 12, and 18 months
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 13 Aug 2008.
- Background: PubMed 8169338Seeman TE, Charpentier PA, Berkman LF, Tinetti ME, Guralnik JM, Albert M, Blazer D, Rowe JW. Predicting changes in physical performance in a high-functioning elderly cohort: MacArthur studies of successful aging. J Gerontol. 1994 May;49(3):M97-108. doi: 10.1093/geronj/49.3.m97.
- Background: PubMed 8694390Schulz R, Heckhausen J. A life span model of successful aging. Am Psychol. 1996 Jul;51(7):702-14. doi: 10.1037//0003-066x.51.7.702.
- Background: PubMed 8678044Strawbridge WJ, Cohen RD, Shema SJ, Kaplan GA. Successful aging: predictors and associated activities. Am J Epidemiol. 1996 Jul 15;144(2):135-41. doi: 10.1093/oxfordjournals.aje.a008900.
- Background: PubMed 10075171Stuck AE, Walthert JM, Nikolaus T, Bula CJ, Hohmann C, Beck JC. Risk factors for functional status decline in community-living elderly people: a systematic literature review. Soc Sci Med. 1999 Feb;48(4):445-69. doi: 10.1016/s0277-9536(98)00370-0.
- Background: PubMed 10737689King AC, Pruitt LA, Phillips W, Oka R, Rodenburg A, Haskell WL. Comparative effects of two physical activity programs on measured and perceived physical functioning and other health-related quality of life outcomes in older adults. J Gerontol A Biol Sci Med Sci. 2000 Feb;55(2):M74-83. doi: 10.1093/gerona/55.2.m74.
- Background: PubMed 14999030Nelson ME, Layne JE, Bernstein MJ, Nuernberger A, Castaneda C, Kaliton D, Hausdorff J, Judge JO, Buchner DM, Roubenoff R, Fiatarone Singh MA. The effects of multidimensional home-based exercise on functional performance in elderly people. J Gerontol A Biol Sci Med Sci. 2004 Feb;59(2):154-60. doi: 10.1093/gerona/59.2.m154.
- Background: PubMed 12181102Strawbridge WJ, Deleger S, Roberts RE, Kaplan GA. Physical activity reduces the risk of subsequent depression for older adults. Am J Epidemiol. 2002 Aug 15;156(4):328-34. doi: 10.1093/aje/kwf047.
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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.
Linda Teri, PhD principal investigator
University of Washington School of Nursing, Northwest Research Group on Aging
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing exercise and health promotion in people with Aging, run by National Institute on Aging (NIA).
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 6 inclusion and 8 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 13 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
physical health and function (time frame: screening, baseline, 3, 6, 12, and 18 months). The study lists 2 primary outcomes in all. 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 NCT00097643, which also lists 7 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 13 Aug 2008.