Sedentary LifestylePhase 3LIFENCT01072500
The LIFE Study - Lifestyle Interventions and Independence for Elders
A Phase 3 study testing Physical Activity and Successful Aging in people with Sedentary Lifestyle and Risk of Disability, run by University of Florida at 8 sites in United States.
Trial summary
Based upon promising results from a pilot study among 424 sedentary older adults who were randomized to a physical activity intervention or a successful aging health education intervention, a Phase 3 multi-center randomized controlled trial is being conducted to compare a moderate-intensity physical activity program… Read more about this study
- Who is it for?
- Ages 70 to 89 years
- Conditions the study is for
- Sedentary Lifestyle, Risk of Disability, Aging
- What is being tested?
- Physical Activity and Successful Aging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,635 participants
- Where
- 8 sitesUnited States
- Study dates
- Feb 2010to Dec 2014
- Phase
- Phase 3
- 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 to 89 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- age 70 to 89 years; (2) summary score <10 on the short physical performance battery (SPPB) (45% are <8);90 (3) sedentary lifestyle; (4) ability to complete the 400 m walk test without an assistive device; and (5) willingness to be randomized to either intervention group.
Who cannot join
- Exclusion Criteria for Factors that May Limit Adherence to Interventions or Affect Conduct of the Trial • Unable or unwilling to give informed consent or accept randomization in either study group • Current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder
- Current consumption of more than 14 alcoholic drinks per week
- Plans to relocate to out of the study area within the next 2 years or plans to be out of the study area for more than 6 consecutive weeks in the next year
- Self-reported inability to walk across a small room
- The use of a walker to complete the 400 m walk and/or unable to complete the 400 m walk without sitting down or the help of another person
- Another member of the household is a participant in the Life Study
Show all 31Show fewer
- Residence too far from the intervention site
- Residence in a nursing home
- Difficulty in communication with study personnel due to speech or hearing problems
- Modified Mini-Mental State Exam (3MSE) score below the cutoff for education:
- African American, 9+ yrs 76, <9 yrs 70; English Speaking Non-African American, 9+ yrs 80, <9 yrs 76; Spanish Speaking, 9+ yrs 80, <9 yrs 70
- Participation in LIFE-Pilot study
- Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
- Exclusion Criteria for Underlying Diseases Likely to Limit Lifespan and/or Affect the Safety of the Interventions
- Severe arthritis (either osteoarthritis or rheumatoid arthritis)
- Cancer requiring treatment in the past three years, except for non-melanoma skin cancers or cancers that have clearly been cured or in the opinion of the investigator carry an excellent prognosis (e.g., Stage 1 cervical cancer)
- Lung disease requiring either regular use of corticosteroid pills or injections or the use of supplemental oxygen
- Development of chest pain or severe shortness of breath on a 400 m self-paced walk test
- Cardiovascular disease (including New York Heart Association Class III or IV congestive heart failure, clinically significant aortic stenosis, history or cardiac arrest, use of a cardiac defibrillator or uncontrolled angina)
- Parkinson's disease or other serious neurological disorder
- Renal disease requiring dialysis
- Other illness of such severity that life expectancy is considered to be less than 12 months
- Conditions not specifically mentioned above may serve as criteria for exclusion at the discretion of the clinical site
- Temporary Exclusion Criteria
- Uncontrolled hypertension (systolic blood pressure > 200 mmHg and/or diastolic blood pressure > 110 mmHg).
- Uncontrolled diabetes with recent weight loss, diabetic coma or frequent insulin reactions.
- Stroke, hip fracture, hip or knee replacement, or spinal surgery in the past 6 months.
- Serious conduction disorder (e.g., 3rd degree heart block), uncontrolled arrhythmia, or new Q waves or ST-segment depressions (>3 mm) on ECG.
- Myocardial infarction, major heart surgery (i.e., valve replacement or bypass surgery), stroke, deep vein thrombosis or pulmonary embolus in the past 6 months.
- Undergoing physical therapy or cardiopulmonary rehabilitation
- Currently enrolled in another randomized trial involving lifestyle or pharmaceutical interventions
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Pennington Biodmedical Research
Baton Rouge, Louisiana, 70808
Tufts University
Boston, Massachusetts, 02111
Northwestern University
Chicago, Illinois, 60611
University of Florida
Gainesville, Florida, 32608
Yale University
New Haven, Connecticut, 06510
Stanford University
Palo Alto, California, 94304
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Based upon promising results from a pilot study among 424 sedentary older adults who were randomized to a physical activity intervention or a successful aging health education intervention, a Phase 3 multi-center randomized controlled trial is being conducted to compare a moderate-intensity physical activity program to a successful aging health education program in 1,600 sedentary older adults who are followed for an average of 2.7 years.
The primary aim was to assess the long-term effects of the proposed interventions on the primary outcome of major mobility disability, defined as inability to walk 400 m.
Read the detailed description
As life expectancy in the United States continues to rise, the maintenance of physical independence among older Americans has emerged as a major clinical and public health priority. Efficient and reliable locomotion, or the ability to move without assistance, is a fundamental feature of human functioning. Older people who lose mobility are less likely to remain in the community, have higher rates of morbidity, mortality, and hospitalizations and experience a poorer quality of life. Several studies have shown that regular physical activity improves physical performance, but definitive evidence showing that mobility disability can be prevented was lacking. A Phase 3 randomized controlled trial was needed to fill this evidence gap.
The LIFE Study was a Phase 3, multicenter randomized controlled trial (RCT) designed to compare a moderate-intensity physical activity program to a successful aging health education program in 1,600 sedentary older persons who are followed for an average of 2.7 years. The primary outcome was major mobility disability, defined as inability to walk 400 m. Secondary outcomes include cognitive function based on the Digit Symbol Substitution Test (DSST) and the Hopkins Verbal Learning Test (HVLT); serious fall injuries; persistent mobility disability; the combined outcome of major mobility disability or death; disability in activities of daily living; and cost-effectiveness. Tertiary outcomes include the combined outcome of mild cognitive impairment or dementia, a composite measure of the cognitive assessment battery, physical performance within pre-specified subgroups defined on the basis of race, gender and baseline physical performance, sleep-wake disturbances, dyspnea, ventilatory capacity, cardiopulmonary events, and cardiovascular events.
The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling. The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises. This trial provides definitive evidence regarding whether physical activity is effective and practical for preventing major mobility disability. These results will have crucial implications for public health prevention in a rapidly aging society, and will fill an important gap in knowledge for practicing evidence-based geriatric medicine. The study will also yield valuable information concerning the efficacy and effectiveness of physical activity across a broad spectrum of important health outcomes. The study will impact both clinical practice and public health policy, and will, therefore, benefit individuals and society.
The Coordinating Center was at the University of Florida and the Data Management Analysis and Quality Control Center (DMAQC) was at Wake Forest University School of Medicine. The 8 field sites participating in the LIFE Study are University of Florida, Gainesville, Florida; Northwestern University, Chicago, Illinois; Pennington Biomedical Research Center, Baton Rouge, Louisiana; University of Pittsburgh, Pittsburgh, Pennsylvania; Stanford University, Palo Alto, California; Tufts University, Boston, Massachusetts; Wake Forest University, Winston-Salem, North Carolina; and Yale University, New Haven, Connecticut.
- Conditions
- Sedentary Lifestyle, Risk of Disability, Aging
- Being tested
- Physical Activity, Successful Aging
- Keywords
- Aging, Physical Activity, Exercise, Sedentary Lifestyle, Mobility, Disability, Falls, Cost effectiveness, Behavioral counseling
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityBehavioural
The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling.
Successful AgingBehavioural
Also called Health Education
The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises.
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity | Active comparator | The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling. Receives: Behavioral: Physical Activity |
| Successful Aging | Active comparator | The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises. Receives: Behavioral: Successful Aging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Mobility Disability, Defined as Incapacity to Walk 400 Meters
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.
Measured: Median 2.7 years/Average 2.6 years
Secondary outcomes (1)
Persistent Mobility Disability (Assessed Every 6 Months)
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.
Measured: Median 2.7 years/Average 2.6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionDec 2013
- Study completionDec 2014
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 (39)Papers the sponsor has linked to this study.
- Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,635 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Marco Pahor, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01072500
- Sponsor's protocol ID
- IRB201701066-N
- Other IDs
- 3U01AG022376-05A2S1, U01AG022376
- Acronym
- LIFE
- Status last verified
- Apr 2018
- First submitted
- 19 Feb 2010
- Last updated
- 7 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: If an investigator outside of a LIFE study team would like access to the LIFE coded dataset, this individual must go through the following steps: 1. Request access to the LIFE website for the purposes of submitting a P\&P proposal to obtain access to the Coded Datasets by going to the LIFE website (www.thelifestudy.org) and clicking on the button "Request for Non-LIFE investigator Access" and completing the request form. 2. Access would be granted to the LIFE website where access to would be provided to the data dictionary, data documentation, and protocol, in addition to the Manuscript Proposal Submission Form. 3. A proposal would be submitted (per current guidelines) to LIFE and reviewed through the usual channels. 4. If approved the Investigator would be sent a Coded Data Use Agreement document to be signed and sent back to the DMAQC for filing. 5. Access to the Coded Datasets would be granted for a period of 10 days.
Publications
LIFE Study Investigators; Pahor M, Blair SN, Espeland M, Fielding R, Gill TM, Guralnik JM, Hadley EC, King AC, Kritchevsky SB, Maraldi C, Miller ME, Newman AB, Rejeski WJ, Romashkan S, Studenski S. Effects of a physical activity intervention on measures of physical performance: Results of the lifestyle interventions and independence for Elders Pilot (LIFE-P) study. J Gerontol A Biol Sci Med Sci. 2006 Nov;61(11):1157-65. doi: 10.1093/gerona/61.11.1157.
PubMed 17167156Fielding RA, Rejeski WJ, Blair S, Church T, Espeland MA, Gill TM, Guralnik JM, Hsu FC, Katula J, King AC, Kritchevsky SB, McDermott MM, Miller ME, Nayfield S, Newman AB, Williamson JD, Bonds D, Romashkan S, Hadley E, Pahor M; LIFE Research Group. The Lifestyle Interventions and Independence for Elders Study: design and methods. J Gerontol A Biol Sci Med Sci. 2011 Nov;66(11):1226-37. doi: 10.1093/gerona/glr123. Epub 2011 Aug 8.
PubMed 21825283Rejeski WJ, Marsh AP, Anton S, Chen SH, Church T, Gill TM, Guralnik JM, Glynn NW, King AC, Rushing J, Ip EH; LIFE Research Group. The MAT-sf: clinical relevance and validity. J Gerontol A Biol Sci Med Sci. 2013 Dec;68(12):1567-74. doi: 10.1093/gerona/glt068. Epub 2013 May 17.
PubMed 23685766Espeland MA, Katula JA, Rushing J, Kramer AF, Jennings JM, Sink KM, Nadkarni NK, Reid KF, Castro CM, Church T, Kerwin DR, Williamson JD, Marottoli RA, Rushing S, Marsiske M, Rapp SR; LIFE Study Group. Performance of a computer-based assessment of cognitive function measures in two cohorts of seniors. Int J Geriatr Psychiatry. 2013 Dec;28(12):1239-50. doi: 10.1002/gps.3949. Epub 2013 Apr 16.
PubMed 23589390Marsh AP, Lovato LC, Glynn NW, Kennedy K, Castro C, Domanchuk K, McDavitt E, Rodate R, Marsiske M, McGloin J, Groessl EJ, Pahor M, Guralnik JM; LIFE Study Research Group. Lifestyle interventions and independence for elders study: recruitment and baseline characteristics. J Gerontol A Biol Sci Med Sci. 2013 Dec;68(12):1549-58. doi: 10.1093/gerona/glt064. Epub 2013 May 28.
PubMed 23716501McDermott MM, Applegate WB, Bonds DE, Buford TW, Church T, Espeland MA, Gill TM, Guralnik JM, Haskell W, Lovato LC, Pahor M, Pepine CJ, Reid KF, Newman A. Ankle brachial index values, leg symptoms, and functional performance among community-dwelling older men and women in the lifestyle interventions and independence for elders study. J Am Heart Assoc. 2013 Nov 12;2(6):e000257. doi: 10.1161/JAHA.113.000257.
PubMed 24222666Rejeski WJ, Axtell R, Fielding R, Katula J, King AC, Manini TM, Marsh AP, Pahor M, Rego A, Tudor-Locke C, Newman M, Walkup MP, Miller ME; LIFE Study Investigator Group. Promoting physical activity for elders with compromised function: the lifestyle interventions and independence for elders (LIFE) study physical activity intervention. Clin Interv Aging. 2013;8:1119-31. doi: 10.2147/CIA.S49737. Epub 2013 Sep 12.
PubMed 24049442Levati E, Zazzara MB, Iurlaro A, Marzetti E, Calvani R, Pahor M, Picca A, Tosato M, Landi F, Bernabei R, Onder G. Lifestyle interventions and medication burden in older adults: insights from the Lifestyle Intervention and Independence for Elders (LIFE) and the Sarcopenia and Physical fRailty iN older people: multi-componenT Treatment strategies (SPRINTT) trials. Eur Geriatr Med. 2025 Oct;16(5):1591-1598. doi: 10.1007/s41999-025-01266-0. Epub 2025 Jul 15.
PubMed 40665144Fielding RA, Atkinson EJ, Aversa Z, White TA, Heeren AA, Mielke MM, Cummings SR, Pahor M, Leeuwenburgh C, LeBrasseur NK. Biomarkers of Cellular Senescence Predict the Onset of Mobility Disability and Are Reduced by Physical Activity in Older Adults. J Gerontol A Biol Sci Med Sci. 2024 Mar 1;79(3):glad257. doi: 10.1093/gerona/glad257.
PubMed 37948612Custodero C, Agosti P, Anton SD, Manini TM, Lozupone M, Panza F, Pahor M, Sabba C, Solfrizzi V. Effect of Physical Activity Intervention on Gait Speed by Frailty Condition: A Randomized Clinical Trial. J Am Med Dir Assoc. 2023 Apr;24(4):489-496. doi: 10.1016/j.jamda.2023.01.023. Epub 2023 Mar 3.
PubMed 36878264Fielding RA, Atkinson EJ, Aversa Z, White TA, Heeren AA, Achenbach SJ, Mielke MM, Cummings SR, Pahor M, Leeuwenburgh C, LeBrasseur NK. Associations between biomarkers of cellular senescence and physical function in humans: observations from the lifestyle interventions for elders (LIFE) study. Geroscience. 2022 Dec;44(6):2757-2770. doi: 10.1007/s11357-022-00685-2. Epub 2022 Nov 11.
PubMed 36367600Shlipak MG, Sheshadri A, Hsu FC, Chen SH, Jotwani V, Tranah G, Fielding RA, Liu CK, Ix J, Coca SG; LIFE Investigators. Effect of Structured, Moderate Exercise on Kidney Function Decline in Sedentary Older Adults: An Ancillary Analysis of the LIFE Study Randomized Clinical Trial. JAMA Intern Med. 2022 Jun 1;182(6):650-659. doi: 10.1001/jamainternmed.2022.1449.
PubMed 35499834Botoseneanu A, Chen H, Ambrosius WT, Allore HG, Anton S, Folta SC, King AC, Nicklas BJ, Spring B, Strotmeyer ES, Gill TM. Metabolic syndrome and the benefit of a physical activity intervention on lower-extremity function: Results from a randomized clinical trial. Exp Gerontol. 2021 Jul 15;150:111343. doi: 10.1016/j.exger.2021.111343. Epub 2021 Apr 10.
PubMed 33848565Fanning J, Rejeski WJ, Chen SH, Guralnik J, Pahor M, Miller ME. Relationships Between Profiles of Physical Activity and Major Mobility Disability in the LIFE Study. J Am Geriatr Soc. 2020 Jul;68(7):1476-1483. doi: 10.1111/jgs.16386. Epub 2020 Mar 20.
PubMed 32196636Fanning J, Rejeski WJ, Chen SH, Nicklas BJ, Walkup MP, Axtell RS, Fielding RA, Glynn NW, King AC, Manini TM, McDermott MM, Newman AB, Pahor M, Tudor-Locke C, Miller ME; LIFE Study Investigators. A Case for Promoting Movement Medicine: Preventing Disability in the LIFE Randomized Controlled Trial. J Gerontol A Biol Sci Med Sci. 2019 Oct 4;74(11):1821-1827. doi: 10.1093/gerona/glz050.
PubMed 30778518
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The LIFE Study - Lifestyle Interventions and Independence for Elders
- ClinicalTrials.gov ID
- NCT01072500
- Acronym / sponsor ID
- LIFE / IRB201701066-N
- Conditions
- Sedentary Lifestyle, Risk of Disability, Aging
- Keywords
- Aging, Physical Activity, Exercise, Sedentary Lifestyle, Mobility, Disability, Falls, Cost effectiveness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,635 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Feb 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 22 Feb 2010 (estimated)
- Results
- Posted 18 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Based upon promising results from a pilot study among 424 sedentary older adults who were randomized to a physical activity intervention or a successful aging health education intervention, a Phase 3 multi-center randomized controlled trial is being conducted to compare a moderate-intensity physical activity program to a successful aging health education program in 1,600 sedentary older adults who are followed for an average of 2.7 years.
The primary aim was to assess the long-term effects of the proposed interventions on the primary outcome of major mobility disability, defined as inability to walk 400 m.
Detailed description
As life expectancy in the United States continues to rise, the maintenance of physical independence among older Americans has emerged as a major clinical and public health priority. Efficient and reliable locomotion, or the ability to move without assistance, is a fundamental feature of human functioning. Older people who lose mobility are less likely to remain in the community, have higher rates of morbidity, mortality, and hospitalizations and experience a poorer quality of life. Several studies have shown that regular physical activity improves physical performance, but definitive evidence showing that mobility disability can be prevented was lacking. A Phase 3 randomized controlled trial was needed to fill this evidence gap.
The LIFE Study was a Phase 3, multicenter randomized controlled trial (RCT) designed to compare a moderate-intensity physical activity program to a successful aging health education program in 1,600 sedentary older persons who are followed for an average of 2.7 years. The primary outcome was major mobility disability, defined as inability to walk 400 m. Secondary outcomes include cognitive function based on the Digit Symbol Substitution Test (DSST) and the Hopkins Verbal Learning Test (HVLT); serious fall injuries; persistent mobility disability; the combined outcome of major mobility disability or death; disability in activities of daily living; and cost-effectiveness. Tertiary outcomes include the combined outcome of mild cognitive impairment or dementia, a composite measure of the cognitive assessment battery, physical performance within pre-specified subgroups defined on the basis of race, gender and baseline physical performance, sleep-wake disturbances, dyspnea, ventilatory capacity, cardiopulmonary events, and cardiovascular events.
The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling. The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises. This trial provides definitive evidence regarding whether physical activity is effective and practical for preventing major mobility disability. These results will have crucial implications for public health prevention in a rapidly aging society, and will fill an important gap in knowledge for practicing evidence-based geriatric medicine. The study will also yield valuable information concerning the efficacy and effectiveness of physical activity across a broad spectrum of important health outcomes. The study will impact both clinical practice and public health policy, and will, therefore, benefit individuals and society.
The Coordinating Center was at the University of Florida and the Data Management Analysis and Quality Control Center (DMAQC) was at Wake Forest University School of Medicine. The 8 field sites participating in the LIFE Study are University of Florida, Gainesville, Florida; Northwestern University, Chicago, Illinois; Pennington Biomedical Research Center, Baton Rouge, Louisiana; University of Pittsburgh, Pittsburgh, Pennsylvania; Stanford University, Palo Alto, California; Tufts University, Boston, Massachusetts; Wake Forest University, Winston-Salem, North Carolina; and Yale University, New Haven, Connecticut.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Activity | Active comparator | Behavioral: Physical ActivityThe physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling. |
| Successful Aging | Active comparator | Behavioral: Successful AgingThe successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises. |
Who may qualify
- Ages
- 70 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- age 70 to 89 years; (2) summary score <10 on the short physical performance battery (SPPB) (45% are <8);90 (3) sedentary lifestyle; (4) ability to complete the 400 m walk test without an assistive device; and (5) willingness to be randomized to either intervention group.
Key exclusion criteria (31 listed)
- Exclusion Criteria for Factors that May Limit Adherence to Interventions or Affect Conduct of the Trial • Unable or unwilling to give informed consent or accept randomization in either study group • Current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder
- African American, 9+ yrs 76, <9 yrs 70; English Speaking Non-African American, 9+ yrs 80, <9 yrs 76; Spanish Speaking, 9+ yrs 80, <9 yrs 70
- Exclusion Criteria for Underlying Diseases Likely to Limit Lifespan and/or Affect the Safety of the Interventions
- Temporary Exclusion Criteria
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 |
|---|---|---|
| Physical ActivityThe physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling. | Behavioural | Physical Activity |
| Successful AgingAlso: Health EducationThe successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises. | Behavioural | Successful Aging |
Primary outcome
Major Mobility Disability, Defined as Incapacity to Walk 400 Meters
Time frame: 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.
1 secondary outcome
Persistent Mobility Disability (Assessed Every 6 Months)
Time frame: Median 2.7 years/Average 2.6 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17167156LIFE Study Investigators; Pahor M, Blair SN, Espeland M, Fielding R, Gill TM, Guralnik JM, Hadley EC, King AC, Kritchevsky SB, Maraldi C, Miller ME, Newman AB, Rejeski WJ, Romashkan S, Studenski S. Effects of a physical activity intervention on measures of physical performance: Results of the lifestyle interventions and independence for Elders Pilot (LIFE-P) study. J Gerontol A Biol Sci Med Sci. 2006 Nov;61(11):1157-65. doi: 10.1093/gerona/61.11.1157.
- Background: PubMed 21825283Fielding RA, Rejeski WJ, Blair S, Church T, Espeland MA, Gill TM, Guralnik JM, Hsu FC, Katula J, King AC, Kritchevsky SB, McDermott MM, Miller ME, Nayfield S, Newman AB, Williamson JD, Bonds D, Romashkan S, Hadley E, Pahor M; LIFE Research Group. The Lifestyle Interventions and Independence for Elders Study: design and methods. J Gerontol A Biol Sci Med Sci. 2011 Nov;66(11):1226-37. doi: 10.1093/gerona/glr123. Epub 2011 Aug 8.
- Results publication: PubMed 23685766Rejeski WJ, Marsh AP, Anton S, Chen SH, Church T, Gill TM, Guralnik JM, Glynn NW, King AC, Rushing J, Ip EH; LIFE Research Group. The MAT-sf: clinical relevance and validity. J Gerontol A Biol Sci Med Sci. 2013 Dec;68(12):1567-74. doi: 10.1093/gerona/glt068. Epub 2013 May 17.
- Results publication: PubMed 23589390Espeland MA, Katula JA, Rushing J, Kramer AF, Jennings JM, Sink KM, Nadkarni NK, Reid KF, Castro CM, Church T, Kerwin DR, Williamson JD, Marottoli RA, Rushing S, Marsiske M, Rapp SR; LIFE Study Group. Performance of a computer-based assessment of cognitive function measures in two cohorts of seniors. Int J Geriatr Psychiatry. 2013 Dec;28(12):1239-50. doi: 10.1002/gps.3949. Epub 2013 Apr 16.
- Results publication: PubMed 23716501Marsh AP, Lovato LC, Glynn NW, Kennedy K, Castro C, Domanchuk K, McDavitt E, Rodate R, Marsiske M, McGloin J, Groessl EJ, Pahor M, Guralnik JM; LIFE Study Research Group. Lifestyle interventions and independence for elders study: recruitment and baseline characteristics. J Gerontol A Biol Sci Med Sci. 2013 Dec;68(12):1549-58. doi: 10.1093/gerona/glt064. Epub 2013 May 28.
- Results publication: PubMed 24222666McDermott MM, Applegate WB, Bonds DE, Buford TW, Church T, Espeland MA, Gill TM, Guralnik JM, Haskell W, Lovato LC, Pahor M, Pepine CJ, Reid KF, Newman A. Ankle brachial index values, leg symptoms, and functional performance among community-dwelling older men and women in the lifestyle interventions and independence for elders study. J Am Heart Assoc. 2013 Nov 12;2(6):e000257. doi: 10.1161/JAHA.113.000257.
- Results publication: PubMed 24049442Rejeski WJ, Axtell R, Fielding R, Katula J, King AC, Manini TM, Marsh AP, Pahor M, Rego A, Tudor-Locke C, Newman M, Walkup MP, Miller ME; LIFE Study Investigator Group. Promoting physical activity for elders with compromised function: the lifestyle interventions and independence for elders (LIFE) study physical activity intervention. Clin Interv Aging. 2013;8:1119-31. doi: 10.2147/CIA.S49737. Epub 2013 Sep 12.
- Derived from this study: PubMed 40665144Levati E, Zazzara MB, Iurlaro A, Marzetti E, Calvani R, Pahor M, Picca A, Tosato M, Landi F, Bernabei R, Onder G. Lifestyle interventions and medication burden in older adults: insights from the Lifestyle Intervention and Independence for Elders (LIFE) and the Sarcopenia and Physical fRailty iN older people: multi-componenT Treatment strategies (SPRINTT) trials. Eur Geriatr Med. 2025 Oct;16(5):1591-1598. doi: 10.1007/s41999-025-01266-0. Epub 2025 Jul 15.
- Derived from this study: PubMed 37948612Fielding RA, Atkinson EJ, Aversa Z, White TA, Heeren AA, Mielke MM, Cummings SR, Pahor M, Leeuwenburgh C, LeBrasseur NK. Biomarkers of Cellular Senescence Predict the Onset of Mobility Disability and Are Reduced by Physical Activity in Older Adults. J Gerontol A Biol Sci Med Sci. 2024 Mar 1;79(3):glad257. doi: 10.1093/gerona/glad257.
- Derived from this study: PubMed 36878264Custodero C, Agosti P, Anton SD, Manini TM, Lozupone M, Panza F, Pahor M, Sabba C, Solfrizzi V. Effect of Physical Activity Intervention on Gait Speed by Frailty Condition: A Randomized Clinical Trial. J Am Med Dir Assoc. 2023 Apr;24(4):489-496. doi: 10.1016/j.jamda.2023.01.023. Epub 2023 Mar 3.
- Derived from this study: PubMed 36367600Fielding RA, Atkinson EJ, Aversa Z, White TA, Heeren AA, Achenbach SJ, Mielke MM, Cummings SR, Pahor M, Leeuwenburgh C, LeBrasseur NK. Associations between biomarkers of cellular senescence and physical function in humans: observations from the lifestyle interventions for elders (LIFE) study. Geroscience. 2022 Dec;44(6):2757-2770. doi: 10.1007/s11357-022-00685-2. Epub 2022 Nov 11.
- Derived from this study: PubMed 35499834Shlipak MG, Sheshadri A, Hsu FC, Chen SH, Jotwani V, Tranah G, Fielding RA, Liu CK, Ix J, Coca SG; LIFE Investigators. Effect of Structured, Moderate Exercise on Kidney Function Decline in Sedentary Older Adults: An Ancillary Analysis of the LIFE Study Randomized Clinical Trial. JAMA Intern Med. 2022 Jun 1;182(6):650-659. doi: 10.1001/jamainternmed.2022.1449.
- Individual participant dataSharing planned: Yes. If an investigator outside of a LIFE study team would like access to the LIFE coded dataset, this individual must go through the following steps: 1. Request access to the LIFE website for the purposes of submitting a P\&P proposal to obtain access to the Coded Datasets by going to the LIFE website (www.thelifestudy.org) and clicking on the button "Request for Non-LIFE investigator Access" and completing the request form. 2. Access would be granted to the LIFE website where access to would be provided to the data dictionary, data documentation, and protocol, in addition to the Manuscript Proposal Submission Form. 3. A proposal would be submitted (per current guidelines) to LIFE and reviewed through the usual channels. 4. If approved the Investigator would be sent a Coded Data Use Agreement document to be signed and sent back to the DMAQC for filing. 5. Access to the Coded Datasets would be granted for a period of 10 days.
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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.
Marco Pahor, MD principal investigator
University of Florida
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Physical Activity and Successful Aging in people with Sedentary Lifestyle and Risk of Disability, run by University of Florida at 8 sites 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 1 inclusion and 31 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 7 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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.
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?
Yes. Results are posted in the registry (first posted 18 Apr 2016). 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?
Major Mobility Disability, Defined as Incapacity to Walk 400 Meters (time frame: Median 2.7 years/Average 2.6 years). 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 NCT01072500, which also lists 39 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 7 May 2018.