Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005494
Status:
COMPLETED
Last Update Posted:
2016-02-29
First Post:
2000-05-25
Brief Title:
Prospective Study of Health in Runners and Walkers
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-07
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:
To compare rates of coronary heart disease CHD cancer total mortality and exercise injuries in 68000 runners and 68000 walkers during four years of surveillance
Detailed Description:
BACKGROUND
Current government physical fitness guidelines state that 1 the majority of the health benefits from physical activity can be obtained by walking two miles briskly on most days of the week and 2 the health benefits of physical activity depend principally on the total amount of activity rather than the intensity of the activity Nevertheless there are currently no prospective epidemiological studies extant designed specifically to directly contrast the health benefits and costs of moderate exercise eg walking versus vigorous exercise eg running
DESIGN NARRATIVE
Before the start of the study 233000 person-years of follow-up had been accumulated in 56000 runners between 1991 and 1997 The runners were resurveyed in 1997 along with 68000 walkers The walkers were also solicited through the publication of the questionnaire in Walking magazine followed by a direct mailing of the questionnaire to 425000 subscribers Total and cause-specific mortality will be determined from the National Death Index fatal and nonfatal cancers will be identified from the National Cancer Institutes Surveillance Epidemiology and End Results SEER and 46 state registries nonfatal coronary heart disease and injuries will be determined from questionnaires Survival analyses will be used to test whether runners have greater reduction in heart disease total mortality and cancer per unit of exercise Exercise-related injuries from walking and running will also be examined Power calculations suggest that detection of differences between runners and walkers as small as 11 for total mortality 16 for CHD 12 for total cancers and 36 for breast cancer will be possible The differences will be adjusted for weekly kilocalories expended by walking and running for walking and running distance and for time spent on each activity to test whether these variables account for differences in disease rates between walkers and runners
By the end of the study 517000 person years in 68000 runners between 1991 and 2001 will be available for analysis Survival analysis will be used to test for a dose-response relationship between running mileage and CHD and cancer risk and whether this relationship is affected by running intensity running frequency running history gender adiposity age or medication use Using conservative rates 25 below published values statistical power calculations suggest that detectable reduction in coronary heart disease risk as small as 071 per mile will be possible which is far below the estimated reduction from other published studies 21 Additionally a detectable reduction in breast cancer risk as small as 15 per mile run in women is calculated which is below the 17 reduction in risk estimated from other published data
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Current government physical fitness guidelines state that 1 the majority of the health benefits from physical activity can be obtained by walking two miles briskly on most days of the week and 2 the health benefits of physical activity depend principally on the total amount of activity rather than the intensity of the activity Nevertheless there are currently no prospective epidemiological studies extant designed specifically to directly contrast the health benefits and costs of moderate exercise eg walking versus vigorous exercise eg running
DESIGN NARRATIVE
Before the start of the study 233000 person-years of follow-up had been accumulated in 56000 runners between 1991 and 1997 The runners were resurveyed in 1997 along with 68000 walkers The walkers were also solicited through the publication of the questionnaire in Walking magazine followed by a direct mailing of the questionnaire to 425000 subscribers Total and cause-specific mortality will be determined from the National Death Index fatal and nonfatal cancers will be identified from the National Cancer Institutes Surveillance Epidemiology and End Results SEER and 46 state registries nonfatal coronary heart disease and injuries will be determined from questionnaires Survival analyses will be used to test whether runners have greater reduction in heart disease total mortality and cancer per unit of exercise Exercise-related injuries from walking and running will also be examined Power calculations suggest that detection of differences between runners and walkers as small as 11 for total mortality 16 for CHD 12 for total cancers and 36 for breast cancer will be possible The differences will be adjusted for weekly kilocalories expended by walking and running for walking and running distance and for time spent on each activity to test whether these variables account for differences in disease rates between walkers and runners
By the end of the study 517000 person years in 68000 runners between 1991 and 2001 will be available for analysis Survival analysis will be used to test for a dose-response relationship between running mileage and CHD and cancer risk and whether this relationship is affected by running intensity running frequency running history gender adiposity age or medication use Using conservative rates 25 below published values statistical power calculations suggest that detectable reduction in coronary heart disease risk as small as 071 per mile will be possible which is far below the estimated reduction from other published studies 21 Additionally a detectable reduction in breast cancer risk as small as 15 per mile run in women is calculated which is below the 17 reduction in risk estimated from other published data
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL058621 | NIH | None | httpsreporternihgovquickSearchR01HL058621 |