The LIFE Study - Lifestyle Interventions and Independence for Elders

Not Recruiting

Trial ID: NCT01072500


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.

Official Title

The LIFE Study - Lifestyle Interventions and Independence for Elders

Stanford Investigator(s)


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

      - 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

   • 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

   • 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

      - Stroke, hip fracture, hip or knee replacement, or spinal surgery in the past 6

      - 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


behavioral: Physical Activity

behavioral: Successful Aging

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cynthia Castro