Clinical trial NCT01072500: The LIFE Study - Lifestyle Interventions and Independence for Elders
Official title: The LIFE Study - Lifestyle Interventions and Independence for Elders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sedentary Lifestyle
Risk of Disability
Aging
Keywords: Aging
Physical Activity
Exercise
Sedentary Lifestyle
Mobility
Disability
Falls
Cost effectiveness
Behavioral counseling
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2010-02-22
Enrollment: 1635
Sex: ALL
Minimum age (years): 70
Maximum age (years): 89
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

1. 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.

   Exclusion Criteria:

   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
   * 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

Primary outcomes:
measure: Major Mobility Disability, Defined as Incapacity to Walk 400 Meters
timeFrame: Median 2.7 years/Average 2.6 years
Secondary outcomes:
measure: Persistent Mobility Disability (Assessed Every 6 Months)
timeFrame: Median 2.7 years/Average 2.6 years
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Baton Rouge
country: United States
facility: Pennington Biodmedical Research
state: Louisiana
city: Boston
country: United States
facility: Tufts University
state: Massachusetts
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Florida
name: Marco Pahor, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Fielding 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.
citation: Rejeski 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.
citation: Espeland 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.
citation: Marsh 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.
citation: McDermott 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.
citation: Rejeski 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.
citation: Fielding 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.
citation: Shlipak 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.
citation: Botoseneanu 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.
citation: Fanning 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.
citation: Fanning 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.
citation: Liu Z, Hsu FC, Trombetti A, King AC, Liu CK, Manini TM, Fielding RA, Pahor M, Newman AB, Kritchevsky S, Gill TM; LIFE Study investigators. Effect of 24-month physical activity on cognitive frailty and the role of inflammation: the LIFE randomized clinical trial. BMC Med. 2018 Oct 24;16(1):185. doi: 10.1186/s12916-018-1174-8.
citation: Datta R, Trentalange M, Van Ness PH, McGloin JM, Guralnik JM, Miller ME, Walkup MP, Nadkarni N, Pahor M, Gill TM, Quagliarello V, Juthani-Mehta M; LIFE Study Group. Serious adverse events of older adults in nursing home and community intervention trials. Contemp Clin Trials Commun. 2017 Dec 21;9:77-80. doi: 10.1016/j.conctc.2017.12.004. eCollection 2018 Mar.
citation: Rosso AL, Metti AL, Glynn NW, Boudreau RM, Rejeski WJ, Bohnen N, Chen H, Johannsen NM, King AC, Manini TM, Pahor M, Studenski SA, Fragoso CAV, Rosano C; LIFE Study Group. Dopamine-Related Genotypes and Physical Activity Change During an Intervention: The Lifestyle Interventions and Independence for Elders Study. J Am Geriatr Soc. 2018 Jul;66(6):1172-1179. doi: 10.1111/jgs.15369. Epub 2018 Apr 10.
citation: Cochrane SK, Chen SH, Fitzgerald JD, Dodson JA, Fielding RA, King AC, McDermott MM, Manini TM, Marsh AP, Newman AB, Pahor M, Tudor-Locke C, Ambrosius WT, Buford TW; LIFE Study Research Group. Association of Accelerometry-Measured Physical Activity and Cardiovascular Events in Mobility-Limited Older Adults: The LIFE (Lifestyle Interventions and Independence for Elders) Study. J Am Heart Assoc. 2017 Dec 2;6(12):e007215. doi: 10.1161/JAHA.117.007215.
citation: Kritchevsky SB, Lovato L, Handing EP, Blair S, Botoseneanu A, Guralnik JM, Liu C, King A, Marsh AP, Pahor M, Rejeski WJ, Spring B, Manini T. Exercise's effect on mobility disability in older adults with and without obesity: The LIFE study randomized clinical trial. Obesity (Silver Spring). 2017 Jul;25(7):1199-1205. doi: 10.1002/oby.21860.
citation: Gill TM, Beavers DP, Guralnik JM, Pahor M, Fielding RA, Hauser M, Manini TM, Marsh AP, McDermott MM, Newman AB, Allore HG, Miller ME; LIFE Study Investigators. The effect of intervening hospitalizations on the benefit of structured physical activity in promoting independent mobility among community-living older persons: secondary analysis of a randomized controlled trial. BMC Med. 2017 Mar 28;15(1):65. doi: 10.1186/s12916-017-0824-6.
citation: King AC, Salvo D, Banda JA, Ahn DK, Chapman JE, Gill TM, Fielding RA, Demons J, Tudor-Locke C, Rosso A, Pahor M, Frank LD. Preserving older adults' routine outdoor activities in contrasting neighborhood environments through a physical activity intervention. Prev Med. 2017 Mar;96:87-93. doi: 10.1016/j.ypmed.2016.12.049. Epub 2016 Dec 28.
citation: O Hartaigh B, Lovato LC, Pahor M, Buford TW, Dodson JA, Forman DE, Buman MP, Demons JL, Santanasto AJ, Liu C, Miller ME, McDermott MM, Gill TM; LIFE Study Group. Effect of a Long-Term Physical Activity Intervention on Resting Pulse Rate in Older Persons: Results from the Lifestyle Interventions and Independence for Elders Study. J Am Geriatr Soc. 2016 Dec;64(12):2511-2516. doi: 10.1111/jgs.14380. Epub 2016 Oct 27.
citation: Gill TM, Guralnik JM, Pahor M, Church T, Fielding RA, King AC, Marsh AP, Newman AB, Pellegrini CA, Chen SH, Allore HG, Miller ME; LIFE Study Investigators. Effect of Structured Physical Activity on Overall Burden and Transitions Between States of Major Mobility Disability in Older Persons: Secondary Analysis of a Randomized Trial. Ann Intern Med. 2016 Dec 20;165(12):833-840. doi: 10.7326/M16-0529. Epub 2016 Sep 27.
citation: Marsh AP, Applegate WB, Guralnik JM, Jack Rejeski W, Church TS, Fielding RA, Gill TM, King AC, Kritchevsky SB, Manini TM, McDermott MM, Newman AB, Stowe CL, Walkup MP, Pahor M, Miller ME; LIFE Study Investigators. Hospitalizations During a Physical Activity Intervention in Older Adults at Risk of Mobility Disability: Analyses from the Lifestyle Interventions and Independence for Elders Randomized Clinical Trial. J Am Geriatr Soc. 2016 May;64(5):933-43. doi: 10.1111/jgs.14114.
citation: Bann D, Chen H, Bonell C, Glynn NW, Fielding RA, Manini T, King AC, Pahor M, Mihalko SL, Gill TM; Life Study investigators. Socioeconomic differences in the benefits of structured physical activity compared with health education on the prevention of major mobility disability in older adults: the LIFE study. J Epidemiol Community Health. 2016 Sep;70(9):930-3. doi: 10.1136/jech-2016-207321. Epub 2016 Apr 8.
citation: Vaz Fragoso CA, Beavers DP, Anton SD, Liu CK, McDermott MM, Newman AB, Pahor M, Stafford RS, Gill TM; Lifestyle Interventions and Independence in Elders Investigators. Effect of Structured Physical Activity on Respiratory Outcomes in Sedentary Elderly Adults with Mobility Limitations. J Am Geriatr Soc. 2016 Mar;64(3):501-9. doi: 10.1111/jgs.14013.
citation: Groessl EJ, Kaplan RM, Castro Sweet CM, Church T, Espeland MA, Gill TM, Glynn NW, King AC, Kritchevsky S, Manini T, McDermott MM, Reid KF, Rushing J, Pahor M; LIFE Study Group. Cost-effectiveness of the LIFE Physical Activity Intervention for Older Adults at Increased Risk for Mobility Disability. J Gerontol A Biol Sci Med Sci. 2016 May;71(5):656-62. doi: 10.1093/gerona/glw001. Epub 2016 Feb 17.
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citation: King AC, Salvo D, Banda JA, Ahn DK, Gill TM, Miller M, Newman AB, Fielding RA, Siordia C, Moore S, Folta S, Spring B, Manini T, Pahor M; LIFE Study Investigators. An observational study identifying obese subgroups among older adults at increased risk of mobility disability: do perceptions of the neighborhood environment matter? Int J Behav Nutr Phys Act. 2015 Dec 18;12:157. doi: 10.1186/s12966-015-0322-1.
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citation: Bann D, Hire D, Manini T, Cooper R, Botoseneanu A, McDermott MM, Pahor M, Glynn NW, Fielding R, King AC, Church T, Ambrosius WT, Gill TM; LIFE Study Group. Light Intensity physical activity and sedentary behavior in relation to body mass index and grip strength in older adults: cross-sectional findings from the Lifestyle Interventions and Independence for Elders (LIFE) study. PLoS One. 2015 Feb 3;10(2):e0116058. doi: 10.1371/journal.pone.0116058. eCollection 2015.
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citation: Pahor M, Guralnik JM, Ambrosius WT, Blair S, Bonds DE, Church TS, Espeland MA, Fielding RA, Gill TM, Groessl EJ, King AC, Kritchevsky SB, Manini TM, McDermott MM, Miller ME, Newman AB, Rejeski WJ, Sink KM, Williamson JD; LIFE study investigators. Effect of structured physical activity on prevention of major mobility disability in older adults: the LIFE study randomized clinical trial. JAMA. 2014 Jun 18;311(23):2387-96. doi: 10.1001/jama.2014.5616.
citation: Vaz Fragoso CA, Beavers DP, Hankinson JL, Flynn G, Berra K, Kritchevsky SB, Liu CK, McDermott MM, Manini TM, Rejeski WJ, Gill TM; Lifestyle Interventions Independence for Elders Study Investigators. Respiratory impairment and dyspnea and their associations with physical inactivity and mobility in sedentary community-dwelling older persons. J Am Geriatr Soc. 2014 Apr;62(4):622-8. doi: 10.1111/jgs.12738. Epub 2014 Mar 17.