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

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ClinicalTrials.gov Identifier: NCT01072500
Recruitment Status : Completed
First Posted : February 22, 2010
Results First Posted : April 18, 2016
Last Update Posted : May 7, 2018
Sponsor:
Collaborators:
National Institute on Aging (NIA)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Florida

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Conditions Sedentary Lifestyle
Risk of Disability
Aging
Interventions Behavioral: Physical Activity
Behavioral: Successful Aging
Enrollment 1635
Recruitment Details 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  
Arm/Group Title Physical Activity Successful Aging (Health Education)
Hide Arm/Group Description The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling. The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises.
Period Title: Overall Study
Started 818 817
Completed 794 803
Not Completed 24 14
Reason Not Completed
Death             2             2
Lost to Follow-up             5             2
Withdrawal by Subject             17             10
Arm/Group Title Physical Activity Successful Aging Total
Hide Arm/Group Description The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling. The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises. Total of all reporting groups
Overall Number of Baseline Participants 818 817 1635
Hide Baseline Analysis Population Description
Baseline characteristics were similar in the 2 groups.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 818 participants 817 participants 1635 participants
78.7  (5.2) 79.1  (5.2) 78.9  (5.2)
[1]
Measure Description: These represent data that was measured and analyzed. We have verified the standard deviation is the same in both arms.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 818 participants 817 participants 1635 participants
Female
547
  66.9%
551
  67.4%
1098
  67.2%
Male
271
  33.1%
266
  32.6%
537
  32.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 818 participants 817 participants 1635 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  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 818 participants 817 participants 1635 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] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 818 participants 817 participants 1635 participants
7.4  (1.6) 7.3  (1.6) 7.4  (1.6)
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 818 participants 817 participants 1635 participants
91.5  (5.6) 91.6  (5.5) 91.5  (5.5)
[1]
Measure Description: Modified Mini-Mental State Exam Higher scores indicate better cognition score
CHAMPS 18 Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Hours/week
Number Analyzed 818 participants 817 participants 1635 participants
15.9  (32.1) 18.2  (33.8) 17.0  (33.0)
[1]
Measure Description: 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  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 818 participants 817 participants 1635 participants
179.3  (39.6) 178.5  (39.9) 178.9  (39.8)
Systolic Blood Pressure   [1] 
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 818 participants 817 participants 1635 participants
127.9  (18.1) 127.0  (17.8) 127.4  (18.0)
[1]
Measure Description: mean of two measures
Diastolic Blood Pressure   [1] 
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 818 participants 817 participants 1635 participants
68.7  (10.3) 67.7  (10.1) 68.2  (10.2)
[1]
Measure Description: mean of two measures
Weight (kg)  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 818 participants 817 participants 1635 participants
81.9  (18.4) 82.0  (19.3) 81.9  (18.8)
Body Mass Index, mean  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 818 participants 817 participants 1635 participants
30.1  (5.9) 30.3  (6.2) 30.2  (6.1)
High blood pressure/hypertension   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 818 participants 817 participants 1635 participants
573 578 1151
[1]
Measure Description: The number of participants in this measurement (high blood pressure) are the ones who self-reported this history.
Heart Attack/Coronary/MI   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 818 participants 817 participants 1635 participants
60 69 129
[1]
Measure Description: 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] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 818 participants 817 participants 1635 participants
26 45 71
[1]
Measure Description: The number of participants in this measurement (heart failure/congestive heart failure) are the ones who self-reported this history.
Pacemaker   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 818 participants 817 participants 1635 participants
33 33 66
[1]
Measure Description: The number of participants in this measurement (pacemaker) are the ones who self-reported this history.
Stroke   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 818 participants 817 participants 1635 participants
57 52 109
[1]
Measure Description: The number of participants in this measurement (stroke) are the ones who self-reported this history.
Cancer   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 818 participants 817 participants 1635 participants
178 192 370
[1]
Measure Description: The number of participants in this measurement (cancer) are the ones who self-reported this history.
Diabetes/High Blood Sugar   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 818 participants 817 participants 1635 participants
198 216 414
[1]
Measure Description: The number of participants in this measurement (diabetes/high blood sugar) are the ones who self-reported this history.
Chronic lung disease   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 818 participants 817 participants 1635 participants
130 123 253
[1]
Measure Description: The number of participants in this measurement (chronic lung disease) are the ones who self-reported this history.
1.Primary Outcome
Title Major Mobility Disability, Defined as Incapacity to Walk 400 Meters
Hide Description The primary outcome of major mobility disability was defined as the inability to complete a 400-m walk test within 15 minutes without sitting and without the help of another person or walker. Use of a cane was acceptable. Participants were asked to walk 400 m at their usual pace, without overexerting, on a 20 meter course for 10 laps (40 meters/lap). Participants were allowed to stop for up to 1 minute for fatigue or related symptoms. When major mobility disability could not be objectively measured because of the inability of the participant to come to the clinic and absence of a suitable walking course at the participant’s home, institution, or hospital, an alternative adjudication of the outcome was based on objective inability to walk 4 meters in less than 10 seconds, or self-, proxy-, or medical record–reported inability to walk across a room. If participants met these alternative criteria, they would not be able to complete the 400 meter walk within 15 minutes.
Time Frame Median 2.7 years/Average 2.6 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Physical Activity Successful Aging
Hide Arm/Group Description:
The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling.
The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises.
Overall Number of Participants Analyzed 818 817
Measure Type: Number
Unit of Measure: participants
246 290
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Physical Activity, Successful Aging
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Regression, Cox
Comments To compare interventions, we used a likelihood ratio test from a Cox regression model, stratified by field center and sex.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.82
Confidence Interval (2-Sided) 95%
0.69 to 0.98
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Persistent Mobility Disability (Assessed Every 6 Months)
Hide Description The assessment of major mobility disability (the inability to complete a 400-m walk test within 15 minutes without sitting and without the help of another person or walker. Use of a cane was acceptable. Participants were asked to walk 400m at their usual pace, without overexerting, on a 20 meter course for 10 laps (40 meters/lap). Participants were allowed to stop for up to 1 minute for fatigue or related symptoms. When MMD could not be objectively measured because of the inability of the participant to come to the clinic and absence of a suitable walking course at the participant’s home, institution, or hospital, an alternative adjudication of the outcome was based on objective inability to walk 4 meters in less than 10 seconds, or self-, proxy-, or medical record–reported inability to walk across a room. If participants met these alternative criteria, they would not be able to complete the 400 m walk within 15 minutes.) at two consecutive time points or MMD followed by death.
Time Frame Median 2.7 years/Average 2.6 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Physical Activity Successful Aging
Hide Arm/Group Description:

The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling.

Physical Activity: The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling.

The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises.

Successful Aging: The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises.

Overall Number of Participants Analyzed 818 817
Measure Type: Number
Unit of Measure: participants
120 162
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Physical Activity, Successful Aging
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.72
Confidence Interval (2-Sided) 95%
0.57 to 0.91
Estimation Comments [Not Specified]
Time Frame Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years.
Adverse Event Reporting Description

To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months.

Non-serious AEs were collected without regard to the specific AE term.

 
Arm/Group Title Physical Activity Successful Aging
Hide Arm/Group Description The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling. The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises.
All-Cause Mortality
Physical Activity Successful Aging
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Physical Activity Successful Aging
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   404/818 (49.39%)      373/817 (45.65%)    
Blood and lymphatic system disorders     
ANEMIA   10/818 (1.22%)  15 6/817 (0.73%)  6
BLOOD AND LYMPHATIC SYSTEM DISORDERS - OTHER, SPECIFY   2/818 (0.24%)  2 2/817 (0.24%)  2
FEBRILE NEUTROPENIA   0/818 (0.00%)  0 1/817 (0.12%)  4
Cardiac disorders     
ACUTE CORONARY SYNDROME   6/818 (0.73%)  6 6/817 (0.73%)  6
AORTIC VALVE DISEASE   3/818 (0.37%)  3 2/817 (0.24%)  2
ASYSTOLE   1/818 (0.12%)  1 0/817 (0.00%)  0
ATRIAL FIBRILLATION   23/818 (2.81%)  28 19/817 (2.33%)  23
ATRIAL FLUTTER   1/818 (0.12%)  1 1/817 (0.12%)  1
ATRIOVENTRICULAR BLOCK COMPLETE   2/818 (0.24%)  2 0/817 (0.00%)  0
CARDIAC ARREST   6/818 (0.73%)  6 7/817 (0.86%)  7
CARDIAC DISORDERS - OTHER, SPECIFY   11/818 (1.34%)  11 8/817 (0.98%)  8
CHEST PAIN - CARDIAC   18/818 (2.20%)  24 12/817 (1.47%)  14
CONDUCTION DISORDER   1/818 (0.12%)  1 2/817 (0.24%)  2
HEART FAILURE   20/818 (2.44%)  24 16/817 (1.96%)  23
MYOCARDIAL INFARCTION   14/818 (1.71%)  14 12/817 (1.47%)  13
PALPITATIONS   1/818 (0.12%)  2 1/817 (0.12%)  1
PAROXYSMAL ATRIAL TACHYCARDIA   0/818 (0.00%)  0 1/817 (0.12%)  1
PERICARDITIS   1/818 (0.12%)  1 1/817 (0.12%)  1
RESTRICTIVE CARDIOMYOPATHY   0/818 (0.00%)  0 1/817 (0.12%)  1
SINUS BRADYCARDIA   3/818 (0.37%)  3 7/817 (0.86%)  7
SUPRAVENTRICULAR TACHYCARDIA   0/818 (0.00%)  0 1/817 (0.12%)  1
VENTRICULAR ARRHYTHMIA   0/818 (0.00%)  0 1/817 (0.12%)  1
VENTRICULAR TACHYCARDIA   2/818 (0.24%)  3 0/817 (0.00%)  0
Ear and labyrinth disorders     
VERTIGO   5/818 (0.61%)  5 6/817 (0.73%)  6
Endocrine disorders     
ADRENAL INSUFFICIENCY   1/818 (0.12%)  2 0/817 (0.00%)  0
ENDOCRINE DISORDERS - OTHER, SPECIFY   1/818 (0.12%)  1 1/817 (0.12%)  1
HYPERPARATHYROIDISM   1/818 (0.12%)  1 0/817 (0.00%)  0
HYPERTHYROIDISM   1/818 (0.12%)  1 0/817 (0.00%)  0
HYPOPARATHYROIDISM   0/818 (0.00%)  0 1/817 (0.12%)  1
Gastrointestinal disorders     
ABDOMINAL PAIN   12/818 (1.47%)  12 6/817 (0.73%)  7
COLITIS   4/818 (0.49%)  4 3/817 (0.37%)  3
COLONIC FISTULA   1/818 (0.12%)  1 0/817 (0.00%)  0
COLONIC HEMORRHAGE   1/818 (0.12%)  1 0/817 (0.00%)  0
COLONIC OBSTRUCTION   2/818 (0.24%)  2 0/817 (0.00%)  0
COLONIC PERFORATION   1/818 (0.12%)  1 2/817 (0.24%)  2
CONSTIPATION   1/818 (0.12%)  2 2/817 (0.24%)  2
DIARRHEA   3/818 (0.37%)  3 4/817 (0.49%)  4
DYSPEPSIA   1/818 (0.12%)  1 1/817 (0.12%)  1
DYSPHAGIA   1/818 (0.12%)  1 3/817 (0.37%)  3
ENTEROCOLITIS   0/818 (0.00%)  0 1/817 (0.12%)  1
ESOPHAGEAL OBSTRUCTION   1/818 (0.12%)  1 0/817 (0.00%)  0
ESOPHAGEAL STENOSIS   0/818 (0.00%)  0 1/817 (0.12%)  1
ESOPHAGEAL ULCER   1/818 (0.12%)  1 0/817 (0.00%)  0
GASTRIC HEMORRHAGE   4/818 (0.49%)  4 0/817 (0.00%)  0
GASTRIC ULCER   2/818 (0.24%)  2 4/817 (0.49%)  5
GASTRITIS   2/818 (0.24%)  2 1/817 (0.12%)  1
GASTROESOPHAGEAL REFLUX DISEASE   2/818 (0.24%)  2 1/817 (0.12%)  1
GASTROINTESTINAL DISORDERS - OTHER, SPECIFY   5/818 (0.61%)  8 3/817 (0.37%)  3
GASTROINTESTINAL PAIN   1/818 (0.12%)  1 1/817 (0.12%)  1
HEMORRHOIDS   0/818 (0.00%)  0 1/817 (0.12%)  1
ILEAL OBSTRUCTION   1/818 (0.12%)  1 1/817 (0.12%)  1
INTRA-ABDOMINAL HEMORRHAGE   3/818 (0.37%)  3 0/817 (0.00%)  0
JEJUNAL OBSTRUCTION   1/818 (0.12%)  1 0/817 (0.00%)  0
LOWER GASTROINTESTINAL HEMORRHAGE   2/818 (0.24%)  3 1/817 (0.12%)  1
NAUSEA   1/818 (0.12%)  1 1/817 (0.12%)  1
OBSTRUCTION GASTRIC   1/818 (0.12%)  1 0/817 (0.00%)  0
PANCREATIC NECROSIS   1/818 (0.12%)  1 0/817 (0.00%)  0
PANCREATITIS   2/818 (0.24%)  2 5/817 (0.61%)  5
RECTAL HEMORRHAGE   3/818 (0.37%)  3 2/817 (0.24%)  3
RECTAL PERFORATION   1/818 (0.12%)  1 0/817 (0.00%)  0
RECTAL STENOSIS   1/818 (0.12%)  1 0/817 (0.00%)  0
SMALL INTESTINAL OBSTRUCTION   8/818 (0.98%)  8 2/817 (0.24%)  2
STOMACH PAIN   0/818 (0.00%)  0 2/817 (0.24%)  2
VOMITING   4/818 (0.49%)  6 3/817 (0.37%)  3
General disorders     
DEATH NOS   4/818 (0.49%)  4 3/817 (0.37%)  3
EDEMA LIMBS   0/818 (0.00%)  0 3/817 (0.37%)  3
EDEMA TRUNK   0/818 (0.00%)  0 1/817 (0.12%)  1
FATIGUE   3/818 (0.37%)  3 1/817 (0.12%)  1
FEVER   1/818 (0.12%)  5 1/817 (0.12%)  2
FLU LIKE SYMPTOMS   0/818 (0.00%)  0 3/817 (0.37%)  3
GAIT DISTURBANCE   1/818 (0.12%)  2 0/817 (0.00%)  0
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - OTHER, SPECIFY   31/818 (3.79%)  49 27/817 (3.30%)  46
INJECTION SITE REACTION   1/818 (0.12%)  1 0/817 (0.00%)  0
MALAISE   0/818 (0.00%)  0 1/817 (0.12%)  1
NON-CARDIAC CHEST PAIN   11/818 (1.34%)  11 8/817 (0.98%)  9
PAIN   0/818 (0.00%)  0 1/817 (0.12%)  1
Hepatobiliary disorders     
CHOLECYSTITIS   3/818 (0.37%)  3 2/817 (0.24%)  2
GALLBLADDER NECROSIS   0/818 (0.00%)  0 1/817 (0.12%)  1
GALLBLADDER OBSTRUCTION   2/818 (0.24%)  2 1/817 (0.12%)  1
GALLBLADDER PAIN   2/818 (0.24%)  2 1/817 (0.12%)  1
HEPATIC FAILURE   1/818 (0.12%)  2 0/817 (0.00%)  0
HEPATIC HEMORRHAGE   0/818 (0.00%)  0 1/817 (0.12%)  1
HEPATOBILIARY DISORDERS - OTHER, SPECIFY   1/818 (0.12%)  1 1/817 (0.12%)  1
Immune system disorders     
ALLERGIC REACTION   5/818 (0.61%)  7 1/817 (0.12%)  1
ANAPHYLAXIS   0/818 (0.00%)  0 1/817 (0.12%)  1
IMMUNE SYSTEM DISORDERS - OTHER, SPECIFY   0/818 (0.00%)  0 1/817 (0.12%)  1
Infections and infestations     
ABDOMINAL INFECTION   0/818 (0.00%)  0 2/817 (0.24%)  2
ANORECTAL INFECTION   0/818 (0.00%)  0 1/817 (0.12%)  1
APPENDICITIS   1/818 (0.12%)  1 1/817 (0.12%)  1
APPENDICITIS PERFORATED   1/818 (0.12%)  1 0/817 (0.00%)  0
BILIARY TRACT INFECTION   1/818 (0.12%)  1 0/817 (0.00%)  0
BLADDER INFECTION   1/818 (0.12%)  1 0/817 (0.00%)  0
BONE INFECTION   1/818 (0.12%)  1 0/817 (0.00%)  0
BRONCHIAL INFECTION   8/818 (0.98%)  9 4/817 (0.49%)  4
CATHETER RELATED INFECTION   1/818 (0.12%)  1 0/817 (0.00%)  0
DEVICE RELATED INFECTION   1/818 (0.12%)  1 0/817 (0.00%)  0
ENCEPHALITIS INFECTION   1/818 (0.12%)  1 0/817 (0.00%)  0
ENTEROCOLITIS INFECTIOUS   1/818 (0.12%)  1 0/817 (0.00%)  0
GALLBLADDER INFECTION   1/818 (0.12%)  1 0/817 (0.00%)  0
INFECTIONS AND INFESTATIONS - OTHER, SPECIFY   6/818 (0.73%)  6 1/817 (0.12%)  1
JOINT INFECTION   0/818 (0.00%)  0 1/817 (0.12%)  1
KIDNEY INFECTION   1/818 (0.12%)  1 1/817 (0.12%)  1
LARYNGITIS   1/818 (0.12%)  1 0/817 (0.00%)  0
LUNG INFECTION   15/818 (1.83%)  17 15/817 (1.84%)  16
OVARIAN INFECTION   0/818 (0.00%)  0 1/817 (0.12%)  1
PHARYNGITIS   1/818 (0.12%)  1 0/817 (0.00%)  0
PROSTATE INFECTION   1/818 (0.12%)  1 1/817 (0.12%)  1
SALIVARY GLAND INFECTION   0/818 (0.00%)  0 1/817 (0.12%)  1
SEPSIS   7/818 (0.86%)  7 3/817 (0.37%)  3
SINUSITIS   1/818 (0.12%)  1 0/817 (0.00%)  0
SKIN INFECTION   6/818 (0.73%)  6 7/817 (0.86%)  9
SOFT TISSUE INFECTION   1/818 (0.12%)  1 0/817 (0.00%)  0
UPPER RESPIRATORY INFECTION   2/818 (0.24%)  2 1/817 (0.12%)  1
URINARY TRACT INFECTION   11/818 (1.34%)  11 13/817 (1.59%)  14
WOUND INFECTION   2/818 (0.24%)  2 1/817 (0.12%)  1
Injury, poisoning and procedural complications     
ANKLE FRACTURE   2/818 (0.24%)  2 1/817 (0.12%)  1
FALL   28/818 (3.42%)  29 31/817 (3.79%)  35
FRACTURE   18/818 (2.20%)  19 19/817 (2.33%)  19
HIP FRACTURE   4/818 (0.49%)  4 4/817 (0.49%)  4
INJURY, POISONING AND PROCEDURAL COMPLICATIONS - OTHER, SPECIFY   0/818 (0.00%)  0 1/817 (0.12%)  1
INTRAOPERATIVE CARDIAC INJURY   0/818 (0.00%)  0 1/817 (0.12%)  1
SEROMA   1/818 (0.12%)  1 0/817 (0.00%)  0
SPINAL FRACTURE   4/818 (0.49%)  4 3/817 (0.37%)  3
WOUND DEHISCENCE   1/818 (0.12%)  1 0/817 (0.00%)  0
WRIST FRACTURE   0/818 (0.00%)  0 1/817 (0.12%)  1
Investigations     
CREATININE INCREASED   1/818 (0.12%)  1 0/817 (0.00%)  0
INR INCREASED   0/818 (0.00%)  0 1/817 (0.12%)  1
PLATELET COUNT DECREASED   2/818 (0.24%)  3 0/817 (0.00%)  0
WHITE BLOOD CELL DECREASED   0/818 (0.00%)  0 1/817 (0.12%)  1
Metabolism and nutrition disorders     
DEHYDRATION   12/818 (1.47%)  12 9/817 (1.10%)  9
HYPERCALCEMIA   0/818 (0.00%)  0 1/817 (0.12%)  1
HYPERGLYCEMIA   6/818 (0.73%)  6 3/817 (0.37%)  3
HYPERKALEMIA   0/818 (0.00%)  0 2/817 (0.24%)  2
HYPERURICEMIA   1/818 (0.12%)  1 0/817 (0.00%)  0
HYPOCALCEMIA   1/818 (0.12%)  2 0/817 (0.00%)  0
HYPOGLYCEMIA   2/818 (0.24%)  2 4/817 (0.49%)  4
HYPONATREMIA   2/818 (0.24%)  2 0/817 (0.00%)  0
METABOLISM AND NUTRITION DISORDERS - OTHER, SPECIFY   0/818 (0.00%)  0 1/817 (0.12%)  1
TUMOR LYSIS SYNDROME   0/818 (0.00%)  0 1/817 (0.12%)  1
Musculoskeletal and connective tissue disorders     
ARTHRALGIA   1/818 (0.12%)  1 0/817 (0.00%)  0
ARTHRITIS   14/818 (1.71%)  15 15/817 (1.84%)  15
BACK PAIN   11/818 (1.34%)  11 7/817 (0.86%)  7
BONE PAIN   0/818 (0.00%)  0 2/817 (0.24%)  2
CHEST WALL PAIN   1/818 (0.12%)  1 2/817 (0.24%)  3
GENERALIZED MUSCLE WEAKNESS   1/818 (0.12%)  1 1/817 (0.12%)  1
JOINT EFFUSION   2/818 (0.24%)  2 0/817 (0.00%)  0
JOINT RANGE OF MOTION DECREASED   1/818 (0.12%)  1 3/817 (0.37%)  3
JOINT RANGE OF MOTION DECREASED CERVICAL SPINE   1/818 (0.12%)  1 0/817 (0.00%)  0
JOINT RANGE OF MOTION DECREASED LUMBAR SPINE   1/818 (0.12%)  1 0/817 (0.00%)  0
MUSCLE WEAKNESS LOWER LIMB   1/818 (0.12%)  1 0/817 (0.00%)  0
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER - OTHER, SPECIFY   9/818 (1.10%)  9 17/817 (2.08%)  18
MUSCULOSKELETAL DEFORMITY   0/818 (0.00%)  0 1/817 (0.12%)  1
MYALGIA   2/818 (0.24%)  2 0/817 (0.00%)  0
MYOSITIS   1/818 (0.12%)  1 1/817 (0.12%)  2
NECK PAIN   4/818 (0.49%)  4 2/817 (0.24%)  2
OSTEOPOROSIS   2/818 (0.24%)  2 0/817 (0.00%)  0
PAIN IN EXTREMITY   1/818 (0.12%)  1 8/817 (0.98%)  9
SOFT TISSUE NECROSIS UPPER LIMB   0/818 (0.00%)  0 1/817 (0.12%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
MYELODYSPLASTIC SYNDROME   1/818 (0.12%)  1 0/817 (0.00%)  0
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - OTHER, SPECIFY   24/818 (2.93%)  31 19/817 (2.33%)  31
Nervous system disorders     
ATAXIA   2/818 (0.24%)  3 0/817 (0.00%)  0
CENTRAL NERVOUS SYSTEM NECROSIS   1/818 (0.12%)  1 0/817 (0.00%)  0
CEREBROSPINAL FLUID LEAKAGE   0/818 (0.00%)  0 1/817 (0.12%)  1
COGNITIVE DISTURBANCE   0/818 (0.00%)  0 1/817 (0.12%)  1
DEPRESSED LEVEL OF CONSCIOUSNESS   1/818 (0.12%)  1 1/817 (0.12%)  1
DIZZINESS   10/818 (1.22%)  11 5/817 (0.61%)  5
DYSESTHESIA   0/818 (0.00%)  0 1/817 (0.12%)  1
ENCEPHALOPATHY   1/818 (0.12%)  1 0/817 (0.00%)  0
FACIAL MUSCLE WEAKNESS   1/818 (0.12%)  1 0/817 (0.00%)  0
FACIAL NERVE DISORDER   0/818 (0.00%)  0 1/817 (0.12%)  1
HEADACHE   1/818 (0.12%)  1 0/817 (0.00%)  0
HYDROCEPHALUS   1/818 (0.12%)  1 0/817 (0.00%)  0
INTRACRANIAL HEMORRHAGE   4/818 (0.49%)  5 3/817 (0.37%)  4
ISCHEMIA CEREBROVASCULAR   0/818 (0.00%)  0 2/817 (0.24%)  3
LETHARGY   0/818 (0.00%)  0 1/817 (0.12%)  1
NERVOUS SYSTEM DISORDERS - OTHER, SPECIFY   4/818 (0.49%)  5 1/817 (0.12%)  1
PERIPHERAL MOTOR NEUROPATHY   1/818 (0.12%)  1 0/817 (0.00%)  0
PERIPHERAL SENSORY NEUROPATHY   1/818 (0.12%)  1 1/817 (0.12%)  1
PRESYNCOPE   5/818 (0.61%)  6 0/817 (0.00%)  0
RADICULITIS   1/818 (0.12%)  1 0/817 (0.00%)  0
SEIZURE   3/818 (0.37%)  4 2/817 (0.24%)  2
STROKE   15/818 (1.83%)  19 22/817 (2.69%)  25
SYNCOPE   13/818 (1.59%)  15 15/817 (1.84%)  17
TRANSIENT ISCHEMIC ATTACKS   10/818 (1.22%)  10 8/817 (0.98%)  9
TREMOR   0/818 (0.00%)  0 1/817 (0.12%)  1
VASOVAGAL REACTION   1/818 (0.12%)  1 0/817 (0.00%)  0
Psychiatric disorders     
ANXIETY   1/818 (0.12%)  1 0/817 (0.00%)  0
CONFUSION   0/818 (0.00%)  0 2/817 (0.24%)  2
DELIRIUM   2/818 (0.24%)  2 0/817 (0.00%)  0
DEPRESSION   1/818 (0.12%)  1 1/817 (0.12%)  1
HALLUCINATIONS   1/818 (0.12%)  1 0/817 (0.00%)  0
MANIA   1/818 (0.12%)  1 0/817 (0.00%)  0
SUICIDE ATTEMPT   1/818 (0.12%)  1 0/817 (0.00%)  0
Renal and urinary disorders     
ACUTE KIDNEY INJURY   4/818 (0.49%)  5 4/817 (0.49%)  4
CHRONIC KIDNEY DISEASE   1/818 (0.12%)  1 0/817 (0.00%)  0
HEMATURIA   1/818 (0.12%)  1 3/817 (0.37%)  3
PROTEINURIA   1/818 (0.12%)  1 0/817 (0.00%)  0
RENAL AND URINARY DISORDERS - OTHER, SPECIFY   1/818 (0.12%)  1 5/817 (0.61%)  5
RENAL CALCULI   3/818 (0.37%)  3 2/817 (0.24%)  2
URINARY INCONTINENCE   1/818 (0.12%)  1 0/817 (0.00%)  0
URINARY RETENTION   2/818 (0.24%)  2 0/817 (0.00%)  0
URINARY TRACT OBSTRUCTION   1/818 (0.12%)  1 0/817 (0.00%)  0
URINARY TRACT PAIN   0/818 (0.00%)  0 2/817 (0.24%)  2
Reproductive system and breast disorders     
PROSTATIC OBSTRUCTION   2/818 (0.24%)  2 0/817 (0.00%)  0
REPRODUCTIVE SYSTEM AND BREAST DISORDERS - OTHER, SPECIFY   1/818 (0.12%)  1 2/817 (0.24%)  2
UTERINE PAIN   1/818 (0.12%)  1 0/817 (0.00%)  0
VAGINAL HEMORRHAGE   0/818 (0.00%)  0 1/817 (0.12%)  1
Respiratory, thoracic and mediastinal disorders     
APNEA   1/818 (0.12%)  1 0/817 (0.00%)  0
ASPIRATION   1/818 (0.12%)  2 1/817 (0.12%)  1
ATELECTASIS   1/818 (0.12%)  1 0/817 (0.00%)  0
BRONCHIAL OBSTRUCTION   1/818 (0.12%)  1 0/817 (0.00%)  0
BRONCHOSPASM   1/818 (0.12%)  1 2/817 (0.24%)  2
COUGH   4/818 (0.49%)  4 1/817 (0.12%)  1
DYSPNEA   12/818 (1.47%)  12 7/817 (0.86%)  8
HICCUPS   0/818 (0.00%)  0 1/817 (0.12%)  1
HYPOXIA   1/818 (0.12%)  1 0/817 (0.00%)  0
PLEURAL EFFUSION   3/818 (0.37%)  4 2/817 (0.24%)  3
PNEUMONITIS   17/818 (2.08%)  23 11/817 (1.35%)  11
PNEUMOTHORAX   0/818 (0.00%)  0 1/817 (0.12%)  1
PRODUCTIVE COUGH   0/818 (0.00%)  0 1/817 (0.12%)  1
PULMONARY FIBROSIS   0/818 (0.00%)  0 1/817 (0.12%)  1
PULMONARY HYPERTENSION   1/818 (0.12%)  1 1/817 (0.12%)  2
RESPIRATORY FAILURE   5/818 (0.61%)  7 4/817 (0.49%)  5
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY   7/818 (0.86%)  7 8/817 (0.98%)  9
WHEEZING   1/818 (0.12%)  1 0/817 (0.00%)  0
Skin and subcutaneous tissue disorders     
BULLOUS DERMATITIS   0/818 (0.00%)  0 1/817 (0.12%)  1
RASH MACULO-PAPULAR   0/818 (0.00%)  0 1/817 (0.12%)  1
SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY   2/818 (0.24%)  2 4/817 (0.49%)  5
SKIN ULCERATION   0/818 (0.00%)  0 1/817 (0.12%)  2
Surgical and medical procedures     
PROSTECTOMY   1/818 (0.12%)  1 0/817 (0.00%)  0
SURGICAL AND MEDICAL PROCEDURES - OTHER, SPECIFY   67/818 (8.19%)  75 74/817 (9.06%)  86
Vascular disorders     
HEMATOMA   3/818 (0.37%)  3 0/817 (0.00%)  0
HYPERTENSION   6/818 (0.73%)  7 8/817 (0.98%)  8
HYPOTENSION   8/818 (0.98%)  8 5/817 (0.61%)  5
PERIPHERAL ISCHEMIA   2/818 (0.24%)  3 1/817 (0.12%)  1
THROMBOEMBOLIC EVENT   11/818 (1.34%)  12 10/817 (1.22%)  12
VASCULAR DISORDERS - OTHER, SPECIFY   5/818 (0.61%)  6 3/817 (0.37%)  3
VISCERAL ARTERIAL ISCHEMIA   0/818 (0.00%)  0 1/817 (0.12%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Physical Activity Successful Aging
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   181/818 (22.13%)      88/817 (10.77%)    
General disorders     
non-serious AES   181/818 (22.13%)  181 88/817 (10.77%)  88
Indicates events were collected by systematic assessment
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
Publications of Results:
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: IRB201701066-N
3U01AG022376-05A2S1 ( U.S. NIH Grant/Contract )
U01AG022376 ( U.S. NIH Grant/Contract )
First Submitted: February 19, 2010
First Posted: February 22, 2010
Results First Submitted: December 8, 2015
Results First Posted: April 18, 2016
Last Update Posted: May 7, 2018