AgingProject LIFENCT00435188
Life 2: Improving Fitness and Function in Elders
A study testing Multi-component physical activity counseling program in people with Aging and Mobility Limitations, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a 12-month physical activity counseling program, compared to usual care, improves physical performance in a sample of older veterans. The primary physical performance outcome is change in gait speed. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Mobility Limitations
- What is being tested?
- Multi-component physical activity counseling program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Apr 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 over
- Followed in VA primary care or geriatrics clinic
- Currently not regularly physically active
- Able to walk 10 meters without human assistance (assistive device acceptable)
Who cannot join
- Age 70 or over
- Followed in VA primary care or geriatrics clinic
- Currently not regularly physically active
- Able to walk 10 meters without human assistance (assistive device acceptable)
- A terminal diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether a 12-month physical activity counseling program, compared to usual care, improves physical performance in a sample of older veterans. The primary physical performance outcome is change in gait speed.
Read the detailed description
Physical inactivity contributes greatly to the health care burden of older adults and is associated with a high prevalence of functional limitations, morbidity, and disability. Rates of physical inactivity are highest among older adults. Older veterans, compared non-veteran older adults, are more likely to be physically inactive and report more limitations in physical function. Increasing physical activity among older veterans is a promising approach to reduce the burden of chronic disease and its associated functional limitations. The purpose of this study is to determine whether a 12-month physical activity counseling program, compared to usual care, improves physical performance in a sample of older veterans The primary physical performance outcome is change in gait speed. Secondary objectives include examination of the effect of intervention between the two groups (intervention and usual care) on physical activity, self-reported physical function, and health-related quality of life. We also will estimate health care costs between the two groups to determine the short-term economic impact of the counseling in the VHA. Design. Randomized controlled clinical trial. Data collection. All consented patients will receive a baseline computer assisted interview and physical performance test to be repeated quarterly for one-year. The primary outcome is change in gait speed, which is highly predictive of subsequent institutionalization and mortality. Secondary outcome measures include: the SF-36 physical function and other relevant subscales, health-related quality of life, physical activity, self-efficacy, and personal functional goals. Differences between groups for non-routine outpatient clinic use and hospitalization will be explored. The cost of providing an intensive intervention (relative to the cost of usual care) will be calculated relative to functional changes between groups. Individuals randomized to the intervention group will receive a physical activity counseling intervention that includes four components. We will measure and assess change at each endpoint (3,6,9, 12, and 24 months) to determine short and long-term efficacy. Secondary analyses will include: (a) effect of intervention on self-reported physical function, physical activity, personal functional goals, and self-efficacy, and (b) comparison of outpatient clinic use and hospitalization costs between treatment arms relative to intervention costs. Duration Four years. Relevance to the VA. Because approximately 50% of veterans over age 74 have a limiting disability, it is imperative to explore strategies that will alter the course of functional decline of our aging veterans.
- Conditions
- Aging, Mobility Limitations
- Being tested
- Multi-component physical activity counseling program
- Keywords
- Aging, Cost analysis, Counseling, Disabled Persons, Health Promotion, Mobility Limitation, Physical Activity, Primary Care, Randomized Clinical Trial, Veterans
- Medical subject headings
- Mobility Limitation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-component physical activity counseling programBehavioural
A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Behavioral: Multi-component physical activity counseling program A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback Receives: Behavioral: Multi-component physical activity counseling program |
| Arm 2 | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usual Gait Speed
Best of two trials over 8-foot walk
Measured: Baseline
Usual Gait Speed
Measured: 3 month
Usual Gait Speed
Measured: 12-month
Rapid Gait Speed
Measured: Baseline
Rapid Gait Speed
Measured: 3-month
Rapid Gait Speed
Measured: 12-month
Secondary outcomes (12)
Physical Activity Frequency (CHAMPS Questionnaire)
Exercise frequency derived from Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire; The Champs assesses the frequency of a range of physical activities
Measured: Baseline
Physical Activity Frequency (CHAMPS Questionnaire)
Exercise frequency derived from Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire; The Champs assesses the frequency of a range of physical activities
Measured: 3 month
Physical Activity Frequency (CHAMPS Questionnaire)
Exercise frequency derived from Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire; The Champs assesses the frequency of a range of physical activities
Measured: 12 month
Self Rated Health
Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good
Measured: Baseline
Self Rated Health
Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good
Measured: 3 month
Self Rated Health
Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good
Measured: 12 month
Sf-36 Physical Function Subscale
This is a subscale of the SF-36 Medical Outcomes Study. The Physical Function subscale assesses a self-reported ability to perform physical tasks. It is normalized for scores to range from 0 to 100 with a higher score indicating better function.
Measured: Baseline
Sf-36 Physical Function Subscale
This is a subscale of the SF-36 Medical Outcomes Study. The Physical Function subscale assesses a self-reported ability to perform physical tasks. It is normalized for scores to range from 0 to 100 with a higher score indicating better function.
Measured: 3 month
Sf-36 Physical Function Subscale
This is a subscale of the SF-36 Medical Outcomes Study. The Physical Function subscale assesses a self-reported ability to perform physical tasks. It is normalized for scores to range from 0 to 100 with a higher score indicating better function.
Measured: 12 month
2 Minute Walk
Distance walked in two minutes in meters
Measured: Baseline
2 Minute Walk
Distance walked in two minutes in meters
Measured: 3 month
2 Minute Walk
Distance walked in two minutes in meters
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2007 (estimated)
- Study startNov 2004
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Miriam C. Morey, PhD, Principal investigator, VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00435188
- Sponsor's protocol ID
- E3386-R
- Acronym
- Project LIFE
- Status last verified
- Jan 2015
- First submitted
- 12 Feb 2007
- Last updated
- 9 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Snyder DC, Morey MC, Sloane R, Stull V, Cohen HJ, Peterson B, Pieper C, Hartman TJ, Miller PE, Mitchell DC, Demark-Wahnefried W. Reach out to ENhancE Wellness in Older Cancer Survivors (RENEW): design, methods and recruitment challenges of a home-based exercise and diet intervention to improve physical function among long-term survivors of breast, prostate, and colorectal cancer. Psychooncology. 2009 Apr;18(4):429-39. doi: 10.1002/pon.1491.
PubMed 19117329Morey MC, Snyder DC, Sloane R, Cohen HJ, Peterson B, Hartman TJ, Miller P, Mitchell DC, Demark-Wahnefried W. Effects of home-based diet and exercise on functional outcomes among older, overweight long-term cancer survivors: RENEW: a randomized controlled trial. JAMA. 2009 May 13;301(18):1883-91. doi: 10.1001/jama.2009.643.
PubMed 19436015Morey MC, Peterson MJ, Pieper CF, Sloane R, Crowley GM, Cowper P, McConnell E, Bosworth H, Ekelund C, Pearson M, Howard T. Project LIFE--Learning to Improve Fitness and Function in Elders: methods, design, and baseline characteristics of randomized trial. J Rehabil Res Dev. 2008;45(1):31-42. doi: 10.1682/jrrd.2007.03.0044.
PubMed 18566924Morey MC, Peterson MJ, Pieper CF, Sloane R, Crowley GM, Cowper PA, McConnell ES, Bosworth HB, Ekelund CC, Pearson MP. The Veterans Learning to Improve Fitness and Function in Elders Study: a randomized trial of primary care-based physical activity counseling for older men. J Am Geriatr Soc. 2009 Jul;57(7):1166-74. doi: 10.1111/j.1532-5415.2009.02301.x. Epub 2009 May 8.
PubMed 19467149Hall KS, Crowley GM, McConnell ES, Bosworth HB, Sloane R, Ekelund CC, Morey MC. Change in goal ratings as a mediating variable between self-efficacy and physical activity in older men. Ann Behav Med. 2010 Jun;39(3):267-73. doi: 10.1007/s12160-010-9177-5.
PubMed 20387023Huffman KM, Sloane R, Peterson MJ, Bosworth HB, Ekelund C, Pearson M, Howard T, Pieper CF, Morey MC. The impact of self-reported arthritis and diabetes on response to a home-based physical activity counselling intervention. Scand J Rheumatol. 2010 May;39(3):233-9. doi: 10.3109/03009740903348973.
PubMed 20429674Huffman KM, Hall KS, Sloane R, Peterson MJ, Bosworth HB, Ekelund C, Pearson M, Howard T, Pieper CF, Morey MC. Is diabetes associated with poorer self-efficacy and motivation for physical activity in older adults with arthritis? Scand J Rheumatol. 2010;39(5):380-6. doi: 10.3109/03009741003605630.
PubMed 20604671Hall KS, Crowley GM, Bosworth HB, Howard TA, Morey MC. Individual progress toward self-selected goals among older adults enrolled in a physical activity counseling intervention. J Aging Phys Act. 2010 Oct;18(4):439-50. doi: 10.1123/japa.18.4.439.
PubMed 20956844Hall KS, Sloane R, Pieper CF, Peterson MJ, Crowley GM, Cowper PA, McConnell ES, Bosworth HB, Ekelund CC, Morey MC. Long-term changes in physical activity following a one-year home-based physical activity counseling program in older adults with multiple morbidities. J Aging Res. 2010 Dec 26;2011:308407. doi: 10.4061/2011/308407.
PubMed 21234104Lum H, Sloane R, Huffman KM, Kraus VB, Thompson DK, Kraus WE, Bain JR, Stevens R, Pieper CF, Taylor GA, Newgard CB, Cohen HJ, Morey MC. Plasma acylcarnitines are associated with physical performance in elderly men. J Gerontol A Biol Sci Med Sci. 2011 May;66(5):548-53. doi: 10.1093/gerona/glr006. Epub 2011 Mar 2.
PubMed 21367961
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Life 2: Improving Fitness and Function in Elders
- ClinicalTrials.gov ID
- NCT00435188
- Acronym / sponsor ID
- Project LIFE / E3386-R
- Conditions
- Aging, Mobility Limitations
- Keywords
- Aging, Cost analysis, Counseling, Disabled Persons, Health Promotion, Mobility Limitation, Physical Activity, Primary Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Nov 2004
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 14 Feb 2007 (estimated)
- Results
- Posted 9 Jan 2015
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 determine whether a 12-month physical activity counseling program, compared to usual care, improves physical performance in a sample of older veterans. The primary physical performance outcome is change in gait speed.
Detailed description
Physical inactivity contributes greatly to the health care burden of older adults and is associated with a high prevalence of functional limitations, morbidity, and disability. Rates of physical inactivity are highest among older adults. Older veterans, compared non-veteran older adults, are more likely to be physically inactive and report more limitations in physical function. Increasing physical activity among older veterans is a promising approach to reduce the burden of chronic disease and its associated functional limitations. The purpose of this study is to determine whether a 12-month physical activity counseling program, compared to usual care, improves physical performance in a sample of older veterans The primary physical performance outcome is change in gait speed. Secondary objectives include examination of the effect of intervention between the two groups (intervention and usual care) on physical activity, self-reported physical function, and health-related quality of life. We also will estimate health care costs between the two groups to determine the short-term economic impact of the counseling in the VHA. Design. Randomized controlled clinical trial. Data collection. All consented patients will receive a baseline computer assisted interview and physical performance test to be repeated quarterly for one-year. The primary outcome is change in gait speed, which is highly predictive of subsequent institutionalization and mortality. Secondary outcome measures include: the SF-36 physical function and other relevant subscales, health-related quality of life, physical activity, self-efficacy, and personal functional goals. Differences between groups for non-routine outpatient clinic use and hospitalization will be explored. The cost of providing an intensive intervention (relative to the cost of usual care) will be calculated relative to functional changes between groups. Individuals randomized to the intervention group will receive a physical activity counseling intervention that includes four components. We will measure and assess change at each endpoint (3,6,9, 12, and 24 months) to determine short and long-term efficacy. Secondary analyses will include: (a) effect of intervention on self-reported physical function, physical activity, personal functional goals, and self-efficacy, and (b) comparison of outpatient clinic use and hospitalization costs between treatment arms relative to intervention costs. Duration Four years. Relevance to the VA. Because approximately 50% of veterans over age 74 have a limiting disability, it is imperative to explore strategies that will alter the course of functional decline of our aging veterans.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: Multi-component physical activity counseling programBehavioral: Multi-component physical activity counseling program A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback |
| Arm 2 | No intervention | –Usual care |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age 70 or over
- Followed in VA primary care or geriatrics clinic
- Currently not regularly physically active
- Able to walk 10 meters without human assistance (assistive device acceptable)
Key exclusion criteria (5 listed)
- Age 70 or over
- Followed in VA primary care or geriatrics clinic
- Currently not regularly physically active
- Able to walk 10 meters without human assistance (assistive device acceptable)
- A terminal diagnosis
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 |
|---|---|---|
| Multi-component physical activity counseling programA one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback | Behavioural | Arm 1 |
Primary outcome
Usual Gait Speed
Time frame: Baseline
Best of two trials over 8-foot walk
Usual Gait Speed
Time frame: 3 month
Usual Gait Speed
Time frame: 12-month
Rapid Gait Speed
Time frame: Baseline
Rapid Gait Speed
Time frame: 3-month
Rapid Gait Speed
Time frame: 12-month
12 secondary outcomes
Physical Activity Frequency (CHAMPS Questionnaire)
Time frame: Baseline
Physical Activity Frequency (CHAMPS Questionnaire)
Time frame: 3 month
Physical Activity Frequency (CHAMPS Questionnaire)
Time frame: 12 month
Self Rated Health
Time frame: Baseline
Self Rated Health
Time frame: 3 month
Self Rated Health
Time frame: 12 month
Sf-36 Physical Function Subscale
Time frame: Baseline
Sf-36 Physical Function Subscale
Time frame: 3 month
Sf-36 Physical Function Subscale
Time frame: 12 month
2 Minute Walk
Time frame: Baseline
2 Minute Walk
Time frame: 3 month
2 Minute Walk
Time frame: 12 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19117329Snyder DC, Morey MC, Sloane R, Stull V, Cohen HJ, Peterson B, Pieper C, Hartman TJ, Miller PE, Mitchell DC, Demark-Wahnefried W. Reach out to ENhancE Wellness in Older Cancer Survivors (RENEW): design, methods and recruitment challenges of a home-based exercise and diet intervention to improve physical function among long-term survivors of breast, prostate, and colorectal cancer. Psychooncology. 2009 Apr;18(4):429-39. doi: 10.1002/pon.1491.
- Background: PubMed 19436015Morey MC, Snyder DC, Sloane R, Cohen HJ, Peterson B, Hartman TJ, Miller P, Mitchell DC, Demark-Wahnefried W. Effects of home-based diet and exercise on functional outcomes among older, overweight long-term cancer survivors: RENEW: a randomized controlled trial. JAMA. 2009 May 13;301(18):1883-91. doi: 10.1001/jama.2009.643.
- Results publication: PubMed 18566924Morey MC, Peterson MJ, Pieper CF, Sloane R, Crowley GM, Cowper P, McConnell E, Bosworth H, Ekelund C, Pearson M, Howard T. Project LIFE--Learning to Improve Fitness and Function in Elders: methods, design, and baseline characteristics of randomized trial. J Rehabil Res Dev. 2008;45(1):31-42. doi: 10.1682/jrrd.2007.03.0044.
- Results publication: PubMed 19467149Morey MC, Peterson MJ, Pieper CF, Sloane R, Crowley GM, Cowper PA, McConnell ES, Bosworth HB, Ekelund CC, Pearson MP. The Veterans Learning to Improve Fitness and Function in Elders Study: a randomized trial of primary care-based physical activity counseling for older men. J Am Geriatr Soc. 2009 Jul;57(7):1166-74. doi: 10.1111/j.1532-5415.2009.02301.x. Epub 2009 May 8.
- Results publication: PubMed 20387023Hall KS, Crowley GM, McConnell ES, Bosworth HB, Sloane R, Ekelund CC, Morey MC. Change in goal ratings as a mediating variable between self-efficacy and physical activity in older men. Ann Behav Med. 2010 Jun;39(3):267-73. doi: 10.1007/s12160-010-9177-5.
- Results publication: PubMed 20429674Huffman KM, Sloane R, Peterson MJ, Bosworth HB, Ekelund C, Pearson M, Howard T, Pieper CF, Morey MC. The impact of self-reported arthritis and diabetes on response to a home-based physical activity counselling intervention. Scand J Rheumatol. 2010 May;39(3):233-9. doi: 10.3109/03009740903348973.
- Results publication: PubMed 20604671Huffman KM, Hall KS, Sloane R, Peterson MJ, Bosworth HB, Ekelund C, Pearson M, Howard T, Pieper CF, Morey MC. Is diabetes associated with poorer self-efficacy and motivation for physical activity in older adults with arthritis? Scand J Rheumatol. 2010;39(5):380-6. doi: 10.3109/03009741003605630.
- Results publication: PubMed 20956844Hall KS, Crowley GM, Bosworth HB, Howard TA, Morey MC. Individual progress toward self-selected goals among older adults enrolled in a physical activity counseling intervention. J Aging Phys Act. 2010 Oct;18(4):439-50. doi: 10.1123/japa.18.4.439.
- Results publication: PubMed 21234104Hall KS, Sloane R, Pieper CF, Peterson MJ, Crowley GM, Cowper PA, McConnell ES, Bosworth HB, Ekelund CC, Morey MC. Long-term changes in physical activity following a one-year home-based physical activity counseling program in older adults with multiple morbidities. J Aging Res. 2010 Dec 26;2011:308407. doi: 10.4061/2011/308407.
- Results publication: PubMed 21367961Lum H, Sloane R, Huffman KM, Kraus VB, Thompson DK, Kraus WE, Bain JR, Stevens R, Pieper CF, Taylor GA, Newgard CB, Cohen HJ, Morey MC. Plasma acylcarnitines are associated with physical performance in elderly men. J Gerontol A Biol Sci Med Sci. 2011 May;66(5):548-53. doi: 10.1093/gerona/glr006. Epub 2011 Mar 2.
- Website containing short physical activity counseling protocols developed for this study. Counseling protocols and physical assessment forms are based on the stage of change transtheoretical models and are modified for older adults.Link provided by the sponsor.
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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.
Miriam C. Morey, PhD principal investigator
VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-component physical activity counseling program in people with Aging and Mobility Limitations, run by US Department of Veterans Affairs 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 4 inclusion and 5 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 9 Jan 2015. 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. 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?
Yes. Results are posted in the registry (first posted 9 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Usual Gait Speed (time frame: Baseline). The study lists 6 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 NCT00435188, which also lists 10 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 9 Jan 2015.