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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  
Number of Participants  
[units: participants]
  818     817     1635  
Age [1]
[units: years]
Mean (Standard Deviation)
  78.7  (5.2)     79.1  (5.2)     78.9  (5.2)  
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 [2]
[units: units on a scale]
Mean (Standard Deviation)
  7.4  (1.6)     7.3  (1.6)     7.4  (1.6)  
3MSE Score, 0-100 scale, mean [3]
[units: units on a scale]
Mean (Standard Deviation)
  91.5  (5.6)     91.6  (5.5)     91.5  (5.5)  
CHAMPS 18 Total Score [4]
[units: hours/week]
Mean (Standard Deviation)
  15.9  (32.1)     18.2  (33.8)     17.0  (33.0)  
Total Cholesterol  
[units: mg/dL]
Mean (Standard Deviation)
  179.3  (39.6)     178.5  (39.9)     178.9  (39.8)  
Systolic Blood Pressure [5]
[units: mmHg]
Mean (Standard Deviation)
  127.9  (18.1)     127.0  (17.8)     127.4  (18.0)  
Diastolic Blood Pressure [5]
[units: mmHg]
Mean (Standard Deviation)
  68.7  (10.3)     67.7  (10.1)     68.2  (10.2)  
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 [6]
[units: participants]
  573     578     1151  
Heart Attack/Coronary/MI [7]
[units: participants]
  60     69     129  
Heart failure/congestive heart failure [8]
[units: participants]
  26     45     71  
Pacemaker [9]
[units: participants]
  33     33     66  
Stroke [10]
[units: participants]
  57     52     109  
Cancer [11]
[units: participants]
  178     192     370  
Diabetes/High Blood Sugar [12]
[units: participants]
  198     216     414  
Chronic lung disease [13]
[units: participants]
  130     123     253  
[1] These represent data that was measured and analyzed. We have verified the standard deviation is the same in both arms.
[2] 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.
[3] Modified Mini-Mental State Exam Higher scores indicate better cognition score
[4] 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.
[5] mean of two measures
[6] The number of participants in this measurement (high blood pressure) are the ones who self-reported this history.
[7] The number of participants in this measurement (heart attack/coronary/MI) are the ones who self-reported this history.
[8] The number of participants in this measurement (heart failure/congestive heart failure) are the ones who self-reported this history.
[9] The number of participants in this measurement (pacemaker) are the ones who self-reported this history.
[10] The number of participants in this measurement (stroke) are the ones who self-reported this history.
[11] The number of participants in this measurement (cancer) are the ones who self-reported this history.
[12] The number of participants in this measurement (diabetes/high blood sugar) are the ones who self-reported this history.
[13] The number of participants in this measurement (chronic lung disease) are the ones who self-reported this history.



  Outcome Measures
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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