Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005555
Status:
COMPLETED
Last Update Posted:
2016-01-08
First Post:
2000-05-25
Brief Title:
Dose Response to Exercise and Cardiovascular Health
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2016-01
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 determine the minimal dose of physical activity necessary to improve cardiovascular CV health by evaluating and aerobically training 500 healthy men and women 30-65 years of age
Detailed Description:
BACKGROUND
Results from the study will provide important data regarding the dose of exercise required to improve cardiovascular health as described both by the NIH Consensus Conference on Physical Activity and CV Health and by the recent Report of the Surgeon General The study was initiated in response to a Program Announcement released in October 1994 on Physical Activity and Cardiopulmonary Health
DESIGN NARRATIVE
Subjects were randomized into one of five groups in a 2x2 factorial design plus a usual care control group n100 in each of 5 groups Subjects trained at a moderate 45-55 percent or high 65-75 percent of maximum heart rate reserve intensity and at a frequency of 3-4 or 5-7 daysweek viz Group 1 65-75 percent at 5-7 daysweek Group 2 65-75 percent at 3-4 daysweek Group 3 45-55 percent at 5-7 daysweekk Group 4 45-55 percent at 3-4 daysweek and Group 5 usual care control Controls received advice from a physician to increase their physical activity The subjects in Groups 1-4 participated in an exercise intervention using walking as the mode of training for a total of 24 months A lifestyle model of physical activity was used in that subjects could accumulate exercise minutes during the day in 10-minute increments or more continuously for a total duration of 30 minutesday and training was conducted where it was most convenient for the subject ie at home work or some combination thereof Tests occurred at baseline 0 12 and 24 months of the intervention
The hypothesis was that Groups 1-4 would show a significant reduction in systolic and diastolic blood pressure and an increase in HDL-cholesterol compared to the usual care control group A second hypothesis was that that there would be significant main effects for both frequency and intensity with the higher levels of each producing greater improvement on the major outcome variables compared to the lower levels of each dose The study also planned to determine the minimal dose response to exercise necessary to elicit significant improvement in cardiovascular and behavioral health factors Finally the project included examination of the effects of age and level of initial test values on outcome variables to determine if their interactions affected the results of the intervention
The study also includes assessment of the effect of specific doses of exercise on the reduction in systolic and diastolic blood pressure and increase in HDL-cholesterol primary outcomes in addition to changes in levels of physical activity aerobic fitness VO2 max body composition percent fat and waist-to-hip ratio triglycerides and LDL-cholesterol secondary outcomes Psychological variables depression anxiety anger and perceived stress and health-related quality of life are also evaluated and the important issue of adherence to exercise is examined with respect to the effect of dose of exercise
Results from the study will provide important data regarding the dose of exercise required to improve cardiovascular health as described both by the NIH Consensus Conference on Physical Activity and CV Health and by the recent Report of the Surgeon General The study was initiated in response to a Program Announcement released in October 1994 on Physical Activity and Cardiopulmonary Health
DESIGN NARRATIVE
Subjects were randomized into one of five groups in a 2x2 factorial design plus a usual care control group n100 in each of 5 groups Subjects trained at a moderate 45-55 percent or high 65-75 percent of maximum heart rate reserve intensity and at a frequency of 3-4 or 5-7 daysweek viz Group 1 65-75 percent at 5-7 daysweek Group 2 65-75 percent at 3-4 daysweek Group 3 45-55 percent at 5-7 daysweekk Group 4 45-55 percent at 3-4 daysweek and Group 5 usual care control Controls received advice from a physician to increase their physical activity The subjects in Groups 1-4 participated in an exercise intervention using walking as the mode of training for a total of 24 months A lifestyle model of physical activity was used in that subjects could accumulate exercise minutes during the day in 10-minute increments or more continuously for a total duration of 30 minutesday and training was conducted where it was most convenient for the subject ie at home work or some combination thereof Tests occurred at baseline 0 12 and 24 months of the intervention
The hypothesis was that Groups 1-4 would show a significant reduction in systolic and diastolic blood pressure and an increase in HDL-cholesterol compared to the usual care control group A second hypothesis was that that there would be significant main effects for both frequency and intensity with the higher levels of each producing greater improvement on the major outcome variables compared to the lower levels of each dose The study also planned to determine the minimal dose response to exercise necessary to elicit significant improvement in cardiovascular and behavioral health factors Finally the project included examination of the effects of age and level of initial test values on outcome variables to determine if their interactions affected the results of the intervention
The study also includes assessment of the effect of specific doses of exercise on the reduction in systolic and diastolic blood pressure and increase in HDL-cholesterol primary outcomes in addition to changes in levels of physical activity aerobic fitness VO2 max body composition percent fat and waist-to-hip ratio triglycerides and LDL-cholesterol secondary outcomes Psychological variables depression anxiety anger and perceived stress and health-related quality of life are also evaluated and the important issue of adherence to exercise is examined with respect to the effect of dose of exercise
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 |
|---|---|---|---|
| R01HL058873 | NIH | None | httpsreporternihgovquickSearchR01HL058873 |