Conditions:
As life expectancy in the United States continues to rise, the maintenance of physical independence among older Americans has emerged as a major clinical and public health priority. Efficient and reliable locomotion, or the ability to move without assistance, is a fundamental feature of human functioning. Older people who lose mobility are less likely to remain in the community, have higher rates of morbidity, mortality, and hospitalizations and experience a poorer quality of life. Several studies have shown that regular physical activity improves physical performance, but definitive evidence showing that mobility disability can be prevented is lacking. A Phase 3 randomized controlled trial is needed to fill this evidence gap.
The LIFE Study is a Phase 3, multicenter randomized controlled trial (RCT) designed to compare a moderate-intensity physical activity program to a successful aging health education program in 1,600 sedentary older persons who are followed for an average of 2.7 years. The primary outcome is major mobility disability, defined as inability to walk 400 m. Secondary outcomes include cognitive function based on the Digit Symbol Substitution Test (DSST) and the Hopkins Verbal Learning Test (HVLT); serious fall injuries; persistent mobility disability; the combined outcome of major mobility disability or death; disability in activities of daily living; and cost-effectiveness. Tertiary outcomes include the combined outcome of mild cognitive impairment or dementia, a composite measure of the cognitive assessment battery, physical performance within pre-specified subgroups defined on the basis of race, gender and baseline physical performance, sleep-wake disturbances, dyspnea, ventilatory capacity, cardiopulmonary events, and cardiovascular events.
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.
This trial will provide definitive evidence regarding whether physical activity is effective and practical for preventing major mobility disability. These results will have crucial implications for public health prevention in a rapidly aging society, and will fill an important gap in knowledge for practicing evidence-based geriatric medicine. The study will also yield valuable information concerning the efficacy and effectiveness of physical activity across a broad spectrum of important health outcomes. The study will impact both clinical practice and public health policy, and will, therefore, benefit individuals and society.
The Coordinating Center is at the University of Florida and the Data Management Analysis and Quality Control Center (DMAQC) is at Wake Forest University School of Medicine. The 8 field sites participating in the LIFE Study are University of Florida, Gainesville, FL; Northwestern University, Chicago, IL; Pennington Biomedical Research Center, Baton Rouge, LA; IL; University of Pittsburgh, Pittsburgh, PA; Stanford University, Palo Alto, CA; Tufts University, Boston, MA; Wake Forest University, Winston-Salem, NC; and Yale University, New Haven, CT.
Start
Date: February 2010
Study Status: Recruiting
Ages Eligible: 70 Years - 89 Years
Gender Eligible: Both
Inclusion Criteria:
1. age 70 to 89 years; (2) summary score <10 on the EPESE short physical performance
battery (SPPB);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 3 months in the next year
- Self-reported inability to walk one block
- The use of a walker or assistive device to complete the 400 m walk
- 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
- 3MS score < 80
- 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
Sponsors:
Phase: Phase 3
First Received: February 19, 2010
Last Updated: Apr 13, 2010
Clinicaltrials.gov ID:
NCT01072500
Study HIC # 0911005926
Conditions:
Intervention: Behavioral: Lifestyle modification
As life expectancy in the United States continues to rise, the maintenance of physical independence among older Americans has emerged as a major clinical and public health priority. Efficient and reliable locomotion, or the ability to move without assistance, is a fundamental feature of human functioning. Older people who lose mobility are less likely to remain in the community, have higher rates of morbidity, mortality, and hospitalizations and experience a poorer quality of life. Several studies have shown that regular physical activity improves physical performance, but definitive evidence showing that mobility disability can be prevented is lacking. A Phase 3 randomized controlled trial is needed to fill this evidence gap.
The LIFE Study is a Phase 3, multicenter randomized controlled trial (RCT) designed to compare a moderate-intensity physical activity program to a successful aging health education program in 1,600 sedentary older persons who are followed for an average of 2.7 years. The primary outcome is major mobility disability, defined as inability to walk 400 m. Secondary outcomes include cognitive function based on the Digit Symbol Substitution Test (DSST) and the Hopkins Verbal Learning Test (HVLT); serious fall injuries; persistent mobility disability; the combined outcome of major mobility disability or death; disability in activities of daily living; and cost-effectiveness. Tertiary outcomes include the combined outcome of mild cognitive impairment or dementia, a composite measure of the cognitive assessment battery, physical performance within pre-specified subgroups defined on the basis of race, gender and baseline physical performance, sleep-wake disturbances, dyspnea, ventilatory capacity, cardiopulmonary events, and cardiovascular events.
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.
This trial will provide definitive evidence regarding whether physical activity is effective and practical for preventing major mobility disability. These results will have crucial implications for public health prevention in a rapidly aging society, and will fill an important gap in knowledge for practicing evidence-based geriatric medicine. The study will also yield valuable information concerning the efficacy and effectiveness of physical activity across a broad spectrum of important health outcomes. The study will impact both clinical practice and public health policy, and will, therefore, benefit individuals and society.
The Coordinating Center is at the University of Florida and the Data Management Analysis and Quality Control Center (DMAQC) is at Wake Forest University School of Medicine. The 8 field sites participating in the LIFE Study are University of Florida, Gainesville, FL; Northwestern University, Chicago, IL; Pennington Biomedical Research Center, Baton Rouge, LA; IL; University of Pittsburgh, Pittsburgh, PA; Stanford University, Palo Alto, CA; Tufts University, Boston, MA; Wake Forest University, Winston-Salem, NC; and Yale University, New Haven, CT.
Date: February 2010
Study Status: Recruiting
Ages Eligible: 70 Years - 89 Years
Gender Eligible: Both
Inclusion Criteria:
1. age 70 to 89 years; (2) summary score <10 on the EPESE short physical performance
battery (SPPB);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 3 months in the next year
- Self-reported inability to walk one block
- The use of a walker or assistive device to complete the 400 m walk
- 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
- 3MS score < 80
- 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
Sponsors:
Phase: Phase 3
First Received: February 19, 2010
Last Updated: Apr 13, 2010
Clinicaltrials.gov ID:
NCT01072500
Study HIC # 0911005926
Joanne McGloin
203-764-9800
joanne.mcgloin@yale.edu
Thomas Gill, MD
Principal Investigator
HIC # 0805003779
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