Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00116194
Status:
COMPLETED
Last Update Posted:
2010-03-25
First Post:
2005-06-27
Brief Title:
The LIFE Study Lifestyle Interventions and Independence for Elders Pilot
Sponsor:
National Institute on Aging NIA
Organization:
National Institute on Aging NIA
Study Overview
Official Title:
Physical Exercise to Prevent Disability Pilot Study
Status:
COMPLETED
Status Verified Date:
2008-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to gather preliminary data that will determine the feasibility of conducting a Phase III randomized controlled trial RCT that will provide definite evidence in the use of physical exercise to prevent mobility disability in older persons
Detailed Description:
As the life expectancy of older Americans increases prevention of age-associated physical function decline and disabilities has emerged as a major clinical and public health priority A critical factor in an older persons ability to function independently is mobility the ability to move without assistance 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 While several studies suggest that physical activity may prevent physical disability including mobility disability in both healthy and frail older adults definitive evidence is lacking A Phase 3 randomized controlled trial is needed to fill this evidence gap Currently data to estimate sample size needs for such a trial are insufficient and further feasibility data should be gathered before such a trial can be effectively designed and implemented
To refine key trial design benchmarks including sample size calculations to demonstrate the feasibility of a full-scale trial and refiningdeveloping recruitment procedures materials and organizational infrastructure the LIFE Lifestyle Interventions for Independence in Elders study conducts a pilot single-blind randomized controlled trial involving comparison of a physical activity program of moderate intensity to a successful aging program Approximately 400 sedentary persons aged 70 to 90 years who are at risk of disability are followed for at least one year at four intervention sites Wake Forest University School of Medicine in Winston Salem NC the University of Pittsburgh in Pittsburgh PA the Cooper Institute in Dallas TX and the Stanford University in Palo Alto CA The Administrative Coordinating Center and the Data Management and Quality Control Center are at Wake Forest University School of Medicine
The LIFE study assesses the combined outcome of major mobility disability defined as the incapacity to walk 400 meters m or death which will be the primary outcome of the full-scale study This outcome has not been used in previous randomized controlled trials and therefore a pilot study is needed to assess its incidence rate Secondary outcomes include ADL disability major fall injuries and cardiovascular events LIFE explores the effects of the intervention on physical performance measures cognitive function health-related quality of life and use of health care services In addition LIFE explores and performs cost-effectiveness analyses of the intervention
This pilot study will yield the necessary preliminary data to design a definitive Phase 3 randomized controlled trial By providing a conclusive answer regarding whether physical activity is effective for preventing major mobility disability or death the results of the full-scale trial will have relevant clinical and public health implications and will fill an important gap in knowledge for practicing evidence-based geriatric medicine
To refine key trial design benchmarks including sample size calculations to demonstrate the feasibility of a full-scale trial and refiningdeveloping recruitment procedures materials and organizational infrastructure the LIFE Lifestyle Interventions for Independence in Elders study conducts a pilot single-blind randomized controlled trial involving comparison of a physical activity program of moderate intensity to a successful aging program Approximately 400 sedentary persons aged 70 to 90 years who are at risk of disability are followed for at least one year at four intervention sites Wake Forest University School of Medicine in Winston Salem NC the University of Pittsburgh in Pittsburgh PA the Cooper Institute in Dallas TX and the Stanford University in Palo Alto CA The Administrative Coordinating Center and the Data Management and Quality Control Center are at Wake Forest University School of Medicine
The LIFE study assesses the combined outcome of major mobility disability defined as the incapacity to walk 400 meters m or death which will be the primary outcome of the full-scale study This outcome has not been used in previous randomized controlled trials and therefore a pilot study is needed to assess its incidence rate Secondary outcomes include ADL disability major fall injuries and cardiovascular events LIFE explores the effects of the intervention on physical performance measures cognitive function health-related quality of life and use of health care services In addition LIFE explores and performs cost-effectiveness analyses of the intervention
This pilot study will yield the necessary preliminary data to design a definitive Phase 3 randomized controlled trial By providing a conclusive answer regarding whether physical activity is effective for preventing major mobility disability or death the results of the full-scale trial will have relevant clinical and public health implications and will fill an important gap in knowledge for practicing evidence-based geriatric medicine
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01AG022376 | NIH | None | httpsreporternihgovquickSearchU01AG022376 |