Trial · NCT01072500
The LIFE Study - Lifestyle Interventions and Independence for Elders
NCT01072500, Phase 3, Completed, University of Florida; results first posted 2016-04-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The LIFE Study - Lifestyle Interventions and Independence for Elders. Trials, record NCT01072500. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01072500
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The LIFE Study - Lifestyle Interventions and Independence for Elders
- NCT number
- NCT01072500
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,635 participants, actual
- Lead sponsor
- University of Florida
- Conditions
- Sedentary Lifestyle, Risk of Disability, Aging
- Interventions
- Physical Activity, Successful Aging
- First posted
- 2010-02-22
- Last updated
- 2018-05-07
- Results first posted
- 2016-04-18
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Major Mobility Disability, Defined as Incapacity to Walk 400 Meters | Median 2.7 years/Average 2.6 years | The primary outcome of major mobility disability was defined as the inability to complete a 400-m walk test within 15 minutes without sitting and without the help of another person or walker. Use of a cane was acceptable. Participants were asked to walk 400 m at their usual pace, without overexerting, on a 20 meter course for 10 laps (40 meters/lap). Participants were allowed to stop for up to 1 minute for fatigue or related symptoms. When major mobility disability could not be objectively measured because of the inability of the participant to come to the clinic and absence of a suitable walking course at the participant's home, institution, or hospital, an alternative adjudication of the outcome was based on objective inability to walk 4 meters in less than 10 seconds, or self-, proxy-, or medical record-reported inability to walk across a room. If participants met these alternative criteria, they would not be able to complete the 400 meter walk within 15 minutes. |
| Secondary | Persistent Mobility Disability (Assessed Every 6 Months) | Median 2.7 years/Average 2.6 years | The assessment of major mobility disability (the inability to complete a 400-m walk test within 15 minutes without sitting and without the help of another person or walker. Use of a cane was acceptable. Participants were asked to walk 400m at their usual pace, without overexerting, on a 20 meter course for 10 laps (40 meters/lap). Participants were allowed to stop for up to 1 minute for fatigue or related symptoms. When MMD could not be objectively measured because of the inability of the participant to come to the clinic and absence of a suitable walking course at the participant's home, institution, or hospital, an alternative adjudication of the outcome was based on objective inability to walk 4 meters in less than 10 seconds, or self-, proxy-, or medical record-reported inability to walk across a room. If participants met these alternative criteria, they would not be able to complete the 400 m walk within 15 minutes.) at two consecutive time points or MMD followed by death. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Major Mobility Disability, Defined as Incapacity to Walk 400 Meters | Median 2.7 years/Average 2.6 years | participants | NUMBER | |
| SECONDARY | Persistent Mobility Disability (Assessed Every 6 Months) | Median 2.7 years/Average 2.6 years | participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Major Mobility Disability, Defined as Incapacity to Walk 400 Meters | Physical Activity | 246 | participants | ||
| Major Mobility Disability, Defined as Incapacity to Walk 400 Meters | Successful Aging | 290 | participants | ||
| Persistent Mobility Disability (Assessed Every 6 Months) | Physical Activity | 120 | participants | ||
| Persistent Mobility Disability (Assessed Every 6 Months) | Successful Aging | 162 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Physical Activity | 818 | |
| Overall Study | STARTED | Successful Aging (Health Education) | 817 | |
| Overall Study | COMPLETED | Physical Activity | 794 | |
| Overall Study | COMPLETED | Successful Aging (Health Education) | 803 | |
| Overall Study | NOT COMPLETED | Physical Activity | 24 | |
| Overall Study | NOT COMPLETED | Successful Aging (Health Education) | 14 |
Source ClinicalTrials.gov
Adverse events478
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | non-serious AES | General disorders | Physical Activity | 181 | 818 | 181 |
| other | non-serious AES | General disorders | Successful Aging | 88 | 817 | 88 |
| serious | ABDOMINAL INFECTION | Infections and infestations | Physical Activity | 0 | 818 | 0 |
| serious | ABDOMINAL INFECTION | Infections and infestations | Successful Aging | 2 | 817 | 2 |
| serious | ABDOMINAL PAIN | Gastrointestinal disorders | Physical Activity | 12 | 818 | 12 |
| serious | ABDOMINAL PAIN | Gastrointestinal disorders | Successful Aging | 6 | 817 | 7 |
| serious | ACUTE CORONARY SYNDROME | Cardiac disorders | Physical Activity | 6 | 818 | 6 |
| serious | ACUTE CORONARY SYNDROME | Cardiac disorders | Successful Aging | 6 | 817 | 6 |
| serious | ACUTE KIDNEY INJURY | Renal and urinary disorders | Physical Activity | 4 | 818 | 5 |
| serious | ACUTE KIDNEY INJURY | Renal and urinary disorders | Successful Aging | 4 | 817 | 4 |
1 to 10 of 478Source ClinicalTrials.gov
See all 478 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Physical Activity | ||
| Total, all-cause mortality | Successful Aging | ||
| Total, other adverse events | Physical Activity | 181 | 818 |
| Total, other adverse events | Successful Aging | 88 | 817 |
| Total, serious adverse events | Physical Activity | 404 | 818 |
| Total, serious adverse events | Successful Aging | 373 | 817 |
Source ClinicalTrials.gov
Papers39
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01AG022376 | The LIFE Study | PAHOR, MARCO | UNIVERSITY OF FLORIDA | NATIONAL INSTITUTE ON AGING | 2003 to 2015 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Physical Activity vs Successful Aging: Persistent Mobility Disability (Assessed Every 6 Months) | Trial comparisons |
| Physical Activity vs Successful Aging: Major Mobility Disability, Defined as Incapacity to Walk 400 Meters | Trial comparisons |
| Physical Activity vs Successful Aging: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01072500
GET https://conductscience.org/api/trials/v1/NCT01072500/events?page=2