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The LIFE Study - Lifestyle Interventions and Independence for Elders (LIFE)

This study has been completed.
Sponsor:
Collaborators:
National Institute on Aging (NIA)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01072500
First received: February 19, 2010
Last updated: March 21, 2016
Last verified: March 2016
Results First Received: December 8, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Sedentary Lifestyle
Risk of Disability
Aging
Interventions: Behavioral: Physical Activity
Behavioral: Successful Aging

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
1,635 participants were randomized over 21-months, with the target of 1,600 reached late Nov 2011. The 1st randomization occurred 3/12/10, and the final randomization on 12/27/11. Participants in the recruitment pipeline completed screening and testing visits and were randomized; hence, the total randomized exceeded the target.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Physical Activity The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling.
Successful Aging (Health Education) The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises.

Participant Flow:   Overall Study
    Physical Activity   Successful Aging (Health Education)
STARTED   818   817 
COMPLETED   794   803 
NOT COMPLETED   24   14 
Death                2                2 
Lost to Follow-up                5                2 
Withdrawal by Subject                17                10 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline characteristics were similar in the 2 groups.

Reporting Groups
  Description
Physical Activity The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling.
Successful Aging The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises.
Total Total of all reporting groups

Baseline Measures
   Physical Activity   Successful Aging   Total 
Overall Participants Analyzed 
[Units: Participants]
 818   817   1635 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 78.7  (5.2)   79.1  (5.2)   78.9  (5.2) 
[1] These represent data that was measured and analyzed. We have verified the standard deviation is the same in both arms.
Gender 
[Units: Participants]
     
Female   547   551   1098 
Male   271   266   537 
Race/Ethnicity, Customized 
[Units: Participants]
     
Hispanic   31   30   61 
White   604   635   1239 
African American   163   125   288 
Asian   7   8   15 
Other/Mixed   10   17   27 
Refused/Missing   3   2   5 
Education 
[Units: Participants]
     
No formal eduction   7   6   13 
Elementary School (k-8)   15   17   32 
High school/equivalent (9-12)   248   236   484 
College (13-17)   321   320   641 
Post Graduate   194   208   402 
Other   32   26   58 
Unknown   1   4   5 
Total SPPB Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 7.4  (1.6)   7.3  (1.6)   7.4  (1.6) 
[1] This is the Short Physical Performance Battery with a Scale from 0-12. Lower scores represent worse physical performance. Three subscales (balance, gait speed, and chair stand) are summed to create the total score.
3MSE Score, 0-100 scale, mean [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 91.5  (5.6)   91.6  (5.5)   91.5  (5.5) 
[1] Modified Mini-Mental State Exam Higher scores indicate better cognition score
CHAMPS 18 Total Score [1] 
[Units: Hours/week]
Mean (Standard Deviation)
 15.9  (32.1)   18.2  (33.8)   17.0  (33.0) 
[1] Community Health Activities Model Program for Seniors - Activity Questionnaire Score is based on hours of moderate-intensity exercise-related activities per week (frequency/week) Total score is the sum of each activity's frequency. The minimum total score is 0 and the maximum is 168.
Total Cholesterol 
[Units: mg/dL]
Mean (Standard Deviation)
 179.3  (39.6)   178.5  (39.9)   178.9  (39.8) 
Systolic Blood Pressure [1] 
[Units: mmHg]
Mean (Standard Deviation)
 127.9  (18.1)   127.0  (17.8)   127.4  (18.0) 
[1] mean of two measures
Diastolic Blood Pressure [1] 
[Units: mmHg]
Mean (Standard Deviation)
 68.7  (10.3)   67.7  (10.1)   68.2  (10.2) 
[1] mean of two measures
Weight (kg) 
[Units: Kg]
Mean (Standard Deviation)
 81.9  (18.4)   82.0  (19.3)   81.9  (18.8) 
Body Mass Index, mean 
[Units: Kg/m^2]
Mean (Standard Deviation)
 30.1  (5.9)   30.3  (6.2)   30.2  (6.1) 
High blood pressure/hypertension [1] 
[Units: Participants]
 573   578   1151 
[1] The number of participants in this measurement (high blood pressure) are the ones who self-reported this history.
Heart Attack/Coronary/MI [1] 
[Units: Participants]
 60   69   129 
[1] The number of participants in this measurement (heart attack/coronary/MI) are the ones who self-reported this history.
Heart failure/congestive heart failure [1] 
[Units: Participants]
 26   45   71 
[1] The number of participants in this measurement (heart failure/congestive heart failure) are the ones who self-reported this history.
Pacemaker [1] 
[Units: Participants]
 33   33   66 
[1] The number of participants in this measurement (pacemaker) are the ones who self-reported this history.
Stroke [1] 
[Units: Participants]
 57   52   109 
[1] The number of participants in this measurement (stroke) are the ones who self-reported this history.
Cancer [1] 
[Units: Participants]
 178   192   370 
[1] The number of participants in this measurement (cancer) are the ones who self-reported this history.
Diabetes/High Blood Sugar [1] 
[Units: Participants]
 198   216   414 
[1] The number of participants in this measurement (diabetes/high blood sugar) are the ones who self-reported this history.
Chronic lung disease [1] 
[Units: Participants]
 130   123   253 
[1] The number of participants in this measurement (chronic lung disease) are the ones who self-reported this history.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Major Mobility Disability, Defined as Incapacity to Walk 400 Meters   [ Time Frame: Median 2.7 years/Average 2.6 years ]

2.  Secondary:   Persistent Mobility Disability (Assessed Every 6 Months)   [ Time Frame: Median 2.7 years/Average 2.6 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Michael Miller
Organization: Wake Forest School of Medicine
phone: 336-716-6837
e-mail: mmiller@wakehealth.edu


Publications of Results:

Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01072500     History of Changes
Other Study ID Numbers: U01AG022376 ( US NIH Grant/Contract Award Number )
3U01AG022376-05A2S1 ( US NIH Grant/Contract Award Number )
Study First Received: February 19, 2010
Results First Received: December 8, 2015
Last Updated: March 21, 2016
Health Authority: United States: Institutional Review Board