The LIFE Study - Lifestyle Interventions and Independence for Elders
Condition: Sedentary Lifestyle; Risk of Disability; Aging
Intervention: Physical Activity; Successful Aging
Intervention description: 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.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 1635.0
Sex: All
Minimum age: 70 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: Aging; Physical Activity; Exercise; Sedentary Lifestyle; Mobility; Disability; Falls; Cost effectiveness; Behavioral counseling

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.
    

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