Lifestyle Interventions and Independence for Elders (LIFE)

Short Study Name (acronym): LIFE – Main Study 

Long Name:Lifestyle Interventions and Independence for Elders

Investigators (list PI first):
Stephen Kritchevsky, PhD
Tina Brinkley, PhD
Pete Brubaker, PhD
Jamehl Demons, MD
Anthony Marsh, PhD
Barbara Nicklas, PhD
Kaycee Sink, MD
Jeff Williamson, MD 

Funding Agency:
National Institute on Aging 

Funding Dates:
2009-2015 

Research questions or aims:

Primary hypothesis:
Compared with a successful aging (SA) health education program, a long-term structured physical activity (PA) program reduces the risk of major mobility disability, defined as incapacity to walk 400 m.

After a thorough evaluation of possible alternative approaches, LIFE has selected as the primary outcome for the full-scale trial time to the onset of major mobility disability. This outcome is adjudicated as described below. The objective component of the major mobility disability outcome is defined as the inability to complete a 400 m walk test within 15 minutes without sitting or the help of another person. Individuals who complete the walk in more than 15 minutes have an extremely slow pace (<0.45 m/sec), which would make their walking capacity of little utility in daily life.91 Selecting a higher cut point, such as 30 or 60 minutes, makes the objective assessment impractical and does not add to the clinical significance of the outcome. Major mobility disability is assessed every six months by staff who are blinded to the intervention assignment.

Secondary and Tertiary Hypotheses

Secondary hypotheses:

Compared with random assignment to a successful aging program, random assignment to a long-term structured physical activity program:

  • Improves pre-specified measures of cognitive function based on the Digit Symbol Test (DSST) and the Hopkins Verbal Learning Test (HVLT);
  • Reduces the risk of serious fall injuries;
  • Reduces the risk of persistent major mobility disability and of the combined outcome of major mobility disability or death;
  • Reduces the risk of disability in activities of daily living (ADLs); and
  • Is cost-effective.

Tertiary hypotheses:
Compared with SA, the PA program

  • Reduces the risk of the combined outcome of all-cause mild cognitive impairment or dementia (MCI/D);
  • Improves performance on a composite measure of cognitive function;
  • Improves physical performance within subgroups defined on the basis of ethnicity/race, gender and baseline performance;
  • Results in improvements in measures of physical performance and walking speed that vary with the amount of intervention received;
  • Improves sleep-wake disturbances and leads to a lower incidence of sleep-wake disturbances;
  • Reduces dyspnea and improves ventilatory capacity;
  • Reduces the risk of hospital admissions for a combined set of cardiopulmonary disorders, including, congestive heart failure, COPD/asthma, pneumonia, and bronchitis; and
  • Reduces the risk of combined cardiovascular events including acute myocardial infarction, stroke, hospital admission for congestive heart failure, hospital admission for peripheral artery disease, coronary artery bypass surgery, angioplasty, abdominal aneurysm, carotid endarterectomy, and cardiovascular death.

Target population: 

Gender:
Men and women are eligible. The LIFE Study endeavors to recruit men and women in rough proportion to their representation in the catchment area population.

Age:
Individuals aged 70-<90 years old are eligible. This age group is selected because it is at high risk of major mobility disability,90 and it may have a sufficiently long life expectancy1 to participate in a full-scale RCT, which would have a duration of 3 to 4 years.

Ethnicity:
All ethnic groups are eligible for the study. The LIFE Study goal is for a study cohort that is at least 22.5% from minority populations (primarily African Americans and Hispanic Americans).

Residency:
Participants must be planning to reside in the area for at least 2 years.

Functional Status:
Summary score <10 on the Short Physical Performance Battery (SPPB).90 Ability to complete the 400 m walk test within 15 minutes without sitting  or the  help of another person. The LIFE Study goal is a target of 45% of randomized participants to have a score of < 8.

Cognitive functioning:
Persons are eligible if they do not report a diagnosis of dementia or score < 80 on the Modified Mini-Mental State (3MSE) Exam. Persons that score < 80 will be advised by the research staff to take the results to his/her PCP for additional review since our testing is for research purposes only.

Physical activity and exercise:

Sedentary lifestyle is operationally defined as spending less than 20 minutes per week in the past month getting regular physical activity. Physical activity includes activities like: brisk walking, jogging, weight lifting, cycling, aerobics, and dancing. In addition, reports less than 125 min/week of moderate physical activity based on the modified 18-item CHAMPS questionnaire.

Chronic disease status:
The LIFE Study recruits individuals both with and without chronic diseases, except for specific conditions described in the exclusion section that may be life-shortening or prevent the participation in a physical activity intervention.

Willingness to participate:
Participants must be willing to give informed consent, be willing to be randomized to either Physical Activity or the Successful Aging Program intervention, and to follow the protocol for the group to which they have been assigned.

Target # to enroll:
200 

Target Dates of enrollment:
4/2010 to 12/2011 

Types of assessments and questionnaires:
Medical history, medications, demographics, physical performance testing, cognitive testing, questionnaires, CHAMPS, Fatigue,  sleep, ECG,  400 Meter walk, vitals 

Other data collected:
Blood, urine, accelerometers, spirometry, ABI 

Study Website (if applicable):thelifestudy.org

Coordinator Contact Info:
Kim Kennedy
Email:  kkennedy@wakehealth.edu
Phone: 336-713-8567 

     

Last Updated: 12-12-2014
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