The LIFE Study - Lifestyle Interventions and Independence for Elders
Condition: Sedentary Lifestyle; Risk of Disability; Aging
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Physical Activity; Successful Aging
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.
Other intervention name(s): Health Education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Aging; Physical Activity; Exercise; Sedentary Lifestyle; Mobility; Disability; Falls; Cost effectiveness; Behavioral counseling