The LIFE Study - Lifestyle Interventions and Independence for Elders

Completed · Phase 3

Conditions studied: Sedentary Lifestyle, Risk of Disability, Aging

In brief

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.

Key facts

Study ID

NCT01072500

Run by

University of Florida

People needed

1635

Starts

2010-02-01

Expected to finish

2014-12-01

Last updated by the study team

2018-05-07

Who can join

Age: 70 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Stanford University — Palo Alto, California, United States
• Yale University — New Haven, Connecticut, United States
• University of Florida — Gainesville, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• Pennington Biodmedical Research — Baton Rouge, Louisiana, United States
• Tufts University — Boston, Massachusetts, United States
• Wake Forest University Baptist Medical Center — Winston-Salem, North Carolina, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.