The LIFE Study - Lifestyle Interventions and Independence for Elders

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01072500
• Date of registration: 19/02/2010
• Primary sponsor: University of Florida
• Public title: The LIFE Study - Lifestyle Interventions and Independence for Elders LIFE
• Scientific title: The LIFE Study - Lifestyle Interventions and Independence for Elders
• Date of first enrolment: February 2010
• Target sample size: 1635
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01072500
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Countries of recruitment

United States

Contacts

• Name: Marco Pahor, MD
• Affiliation: University of Florida

Key inclusion & exclusion criteria

Inclusion Criteria:

1. age 70 to 89 years; (2) summary score <10 on the EPESE 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

- 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 NYHA 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



Age minimum: 70 Years
Age maximum: 89 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Aging

Risk of Disability

Sedentary Lifestyle

Intervention(s)

Behavioral: Lifestyle modification

Primary Outcome(s)

Major mobility disability, defined as incapacity to walk 400 m [Time Frame: Average 2.7 years]

Secondary Outcome(s)

Cognitive Function [Time Frame: 2 years]

combined outcome of major mobility disability or death [Time Frame: 2.7 years]

cost effectiveness [Time Frame: 2.7 years]

disability in activities of daily living (ADLs) [Time Frame: 2.7 years]

persistent major mobility disability [Time Frame: 2.7 years]

Serious fall injuries [Time Frame: Average 2.7 years]

Secondary ID(s)

2U01AG022376-05A2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Heart, Lung, and Blood Institute (NHLBI)

National Institute on Aging (NIA)