Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00092950
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2004-09-24
Brief Title:
Exercise in Women at Risk for Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Pilot Study of a Three Month Intervention for Increasing Physical Activity in Sedentary Women at Risk for Breast Cancer
Status:
COMPLETED
Status Verified Date:
2011-09-28
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:
This 2-part study will examine how much exercise people usually do in the course of their daily lives and how two different types of exercise-stretching and walking-affect the amount of fat in the body and certain hormones in the blood It will also examine whether exercise can be increased by physician counseling with and without the use of a pedometer and if exercising changes levels of stress anxiety and depression
Breast cancer survivors and women at high risk for breast cancer who are between 18 and 75 years of age and who exercise less than 3 times per week may be eligible for this study Candidates are screened with a medical history and physical examination and their endurance and flexibility are tested by stretching exercises and by a 6-minute walk or run
All participants complete study Part 1 Those who are eligible may also participate in Part 2
Part 1 Subjects wear a pedometer a small device that measures the number of steps taken on their waistband during all waking hours for 1 week without changing their usual level of activity Depending on their level of activity subjects may be invited to participate in Part 2 of the study
Part 2 Subjects are placed in either a walking group or a stretching group for 12 weeks At the end of the 12-week period those in the walking group are offered participation in the stretching group and those in the stretching group are offered participation in the walking group
Walking group participants wear a pedometer every day for 12 weeks They are asked to gradually increase the number of steps they take each day to keep a record of their daily step count and to report periodically to the study staff on their progress For 1 week during the study participants also wear a device called an accelerometer that is used to verify the accuracy of the pedometer step counts
Stretching group participants follow a program of stretching exercises for 12 weeks with their progress monitored periodically by staff During week 12 participants wear a pedometer and accelerometer
All Part 2 participants also have the following tests and procedures
Blood draw collected at the beginning and end of the study to test for certain hormones and HDL cholesterol levels
Questionnaires about stress anxiety and depression levels these are completed at the beginning and end of the study and a detailed questionnaire about diet is completed at home or during a clinic visit
Body composition measurement A bioelectrical impedance test which measures body fat is done at the beginning and end of the study For this test the subject lies on an examining table and a small electrical current is passed through electrodes placed on one hand and one foot Although a small electrical current is used this test is not painful
Endurance and flexibility testing At the end of the study participants repeat the 6-minute walk or run endurance test and the stretching flexibility test performed at screening
Breast cancer survivors and women at high risk for breast cancer who are between 18 and 75 years of age and who exercise less than 3 times per week may be eligible for this study Candidates are screened with a medical history and physical examination and their endurance and flexibility are tested by stretching exercises and by a 6-minute walk or run
All participants complete study Part 1 Those who are eligible may also participate in Part 2
Part 1 Subjects wear a pedometer a small device that measures the number of steps taken on their waistband during all waking hours for 1 week without changing their usual level of activity Depending on their level of activity subjects may be invited to participate in Part 2 of the study
Part 2 Subjects are placed in either a walking group or a stretching group for 12 weeks At the end of the 12-week period those in the walking group are offered participation in the stretching group and those in the stretching group are offered participation in the walking group
Walking group participants wear a pedometer every day for 12 weeks They are asked to gradually increase the number of steps they take each day to keep a record of their daily step count and to report periodically to the study staff on their progress For 1 week during the study participants also wear a device called an accelerometer that is used to verify the accuracy of the pedometer step counts
Stretching group participants follow a program of stretching exercises for 12 weeks with their progress monitored periodically by staff During week 12 participants wear a pedometer and accelerometer
All Part 2 participants also have the following tests and procedures
Blood draw collected at the beginning and end of the study to test for certain hormones and HDL cholesterol levels
Questionnaires about stress anxiety and depression levels these are completed at the beginning and end of the study and a detailed questionnaire about diet is completed at home or during a clinic visit
Body composition measurement A bioelectrical impedance test which measures body fat is done at the beginning and end of the study For this test the subject lies on an examining table and a small electrical current is passed through electrodes placed on one hand and one foot Although a small electrical current is used this test is not painful
Endurance and flexibility testing At the end of the study participants repeat the 6-minute walk or run endurance test and the stretching flexibility test performed at screening
Detailed Description:
Background
Evidence suggests that high levels of physical activity can decrease breast cancer risk
Physical activity could therefore represent a viable breast cancer prevention strategy
In order to study the effect of physical activity on breast cancer risk we must first develop feasible and efficacious physical activity interventions
Objectives
Primary
To determine the rate of compliance with a physical activity intervention using a pedometer a physician prescription and a motivational booklet
To determine whether this intervention is more effective than a control of stretching exercises at increasing physical activity
Secondary
To determine whether physical activity as measured by a pedometer correlates with other measures of physical activity
To assess the effect of the physical activity intervention on serum biomarkers quality of life functional capacity and body composition
To examine long-term compliance with a program of increased physical activity and assess post program exercise motivation and adherence
Eligibility
Eligible patients are women age 18-75 who meet one of the following criteria
History of breast cancer without evidence of recurrent disease
Gail model 5 year risk greater than 17
Claus model lifetime risk greater than 20
History of appropriately treated DCIS
History of high risk lesion on breast biopsy ADH ALH LCIS
Known or suspected BRCA1 or BRCA2 mutation
Patients must be sedentary at baseline and must be medically fit to exercise
Design
This is a randomized pilot study designed to assess the feasibility of a physical activity intervention in breast cancer survivors and women at high risk for breast cancer
Stage I Patients undergo a baseline activity evaluation for one week which involves wearing a sealed pedometer - those that have an average daily step count of less than 5000 steps are eligible for randomization
Stage II Patients are assigned to either a walking intervention including a pedometer a physician exercise prescription with a final goal of walking 10000 steps per day and a motivational booklet or a control of stretching exercise for a period of 12 weeks
Biomarkers functional capacity body composition and diet are assessed at the beginning and end of study
This study plans to randomize 80 subjects and has a greater than 90 power to detect a mean increase of 3000 steps per day in intervention subjects
Evidence suggests that high levels of physical activity can decrease breast cancer risk
Physical activity could therefore represent a viable breast cancer prevention strategy
In order to study the effect of physical activity on breast cancer risk we must first develop feasible and efficacious physical activity interventions
Objectives
Primary
To determine the rate of compliance with a physical activity intervention using a pedometer a physician prescription and a motivational booklet
To determine whether this intervention is more effective than a control of stretching exercises at increasing physical activity
Secondary
To determine whether physical activity as measured by a pedometer correlates with other measures of physical activity
To assess the effect of the physical activity intervention on serum biomarkers quality of life functional capacity and body composition
To examine long-term compliance with a program of increased physical activity and assess post program exercise motivation and adherence
Eligibility
Eligible patients are women age 18-75 who meet one of the following criteria
History of breast cancer without evidence of recurrent disease
Gail model 5 year risk greater than 17
Claus model lifetime risk greater than 20
History of appropriately treated DCIS
History of high risk lesion on breast biopsy ADH ALH LCIS
Known or suspected BRCA1 or BRCA2 mutation
Patients must be sedentary at baseline and must be medically fit to exercise
Design
This is a randomized pilot study designed to assess the feasibility of a physical activity intervention in breast cancer survivors and women at high risk for breast cancer
Stage I Patients undergo a baseline activity evaluation for one week which involves wearing a sealed pedometer - those that have an average daily step count of less than 5000 steps are eligible for randomization
Stage II Patients are assigned to either a walking intervention including a pedometer a physician exercise prescription with a final goal of walking 10000 steps per day and a motivational booklet or a control of stretching exercise for a period of 12 weeks
Biomarkers functional capacity body composition and diet are assessed at the beginning and end of study
This study plans to randomize 80 subjects and has a greater than 90 power to detect a mean increase of 3000 steps per day in intervention subjects
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 |
|---|---|---|---|
| 04-C-0276 | None | None | None |