Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00249015
Status:
COMPLETED
Last Update Posted:
2016-07-18
First Post:
2005-11-04
Brief Title:
Trial of Combined Aerobic and Resistance Exercise in Breast Cancer Survivors
Sponsor:
AHS Cancer Control Alberta
Organization:
AHS Cancer Control Alberta
Study Overview
Official Title:
Randomized Controlled Trial of Combined Aerobic and Resistance Exercise in Breast Cancer Survivors The CARE Trial
Status:
COMPLETED
Status Verified Date:
2014-06
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:
Endurance exercise such as walking has been shown to help breast cancer survivors maintain their energy and quality of life while they are receiving chemotherapy but there have not been any studies on weight training In this study the researchers want to determine if a combined program of endurance and weight training exercises is better than a standard amount of endurance exercise or even a higher amount of endurance exercise in breast cancer survivors receiving chemotherapy The study will be an experimental design in which the researchers have breast cancer survivors participate in one of the three different exercise programs The researchers main interest is in patient rated physical functioning and quality of life which they will measure before and after the exercise programs by asking participants how they feel on various rating scales The researchers will also measure their aerobic fitness on a treadmill and how strong they are by having them lift weights
Detailed Description:
BACKGROUND Aerobic exercise has been shown to improve physical fitness and quality of life QoL in breast cancer survivors receiving chemotherapy but no study to date has examined the addition of resistance exercise to aerobic exercise in this population Resistance exercise has proven to be an important adjunct to aerobic exercise in the cardiac rehabilitation population although few trials have controlled for the total volume of exercise
PURPOSE The primary purpose of the present trial is to compare the effects of a combined aerobic and resistance exercise program COMB to a standard moderate volume of aerobic exercise STAN and a higher volume of aerobic exercise HIGH that controls for the total volume of exercise in the COMB arm
METHODS The study will be a prospective three-armed randomized controlled trial conducted in Edmonton coordinating center Ottawa and Vancouver Participants will be 300 breast cancer survivors scheduled to receive adjuvant chemotherapy All three exercise groups will be asked to perform supervised exercise 3 daysweek for the length of their chemotherapy treatment The STAN group will be asked to perform approximately 500 kilocaloriesweek of self-selected aerobic activities eg treadmill cycle ergometer elliptical This arm of the trial is considered standard care based on the emerging consensus of recent systematic reviews and recommendations from major cancer agencies The HIGH group will be asked to complete approximately 1000 kilocaloriesweek of self-selected aerobic activities The COMB group will be asked to complete 1000 kilocaloriesweek split equally between aerobic and resistance exercise The primary endpoint in the trial will be change in physical functioning between baseline and post intervention as assessed by the physical functioning subscale of the Short Form SF 36 scale Secondary endpoints will include cardiorespiratory fitness maximal treadmill test muscular strength 8 repetition maximum tests muscular endurance standard load test at 50 of estimated baseline maximum body composition DEXA scans psychological distress sleep quality exercise adherence and chemotherapy completion rates
RELEVANCE An important issue for breast cancer survivors receiving chemotherapy is whether there is any advantage to increasing the volume of aerobic exercise or adding resistance exercise to a standard aerobic exercise program If there is an advantage then it is important that breast cancer survivors receive this optimal exercise prescription to maximize their ability to cope with their chemotherapy treatments and maintain their physical function and QoL during this difficult time
PURPOSE The primary purpose of the present trial is to compare the effects of a combined aerobic and resistance exercise program COMB to a standard moderate volume of aerobic exercise STAN and a higher volume of aerobic exercise HIGH that controls for the total volume of exercise in the COMB arm
METHODS The study will be a prospective three-armed randomized controlled trial conducted in Edmonton coordinating center Ottawa and Vancouver Participants will be 300 breast cancer survivors scheduled to receive adjuvant chemotherapy All three exercise groups will be asked to perform supervised exercise 3 daysweek for the length of their chemotherapy treatment The STAN group will be asked to perform approximately 500 kilocaloriesweek of self-selected aerobic activities eg treadmill cycle ergometer elliptical This arm of the trial is considered standard care based on the emerging consensus of recent systematic reviews and recommendations from major cancer agencies The HIGH group will be asked to complete approximately 1000 kilocaloriesweek of self-selected aerobic activities The COMB group will be asked to complete 1000 kilocaloriesweek split equally between aerobic and resistance exercise The primary endpoint in the trial will be change in physical functioning between baseline and post intervention as assessed by the physical functioning subscale of the Short Form SF 36 scale Secondary endpoints will include cardiorespiratory fitness maximal treadmill test muscular strength 8 repetition maximum tests muscular endurance standard load test at 50 of estimated baseline maximum body composition DEXA scans psychological distress sleep quality exercise adherence and chemotherapy completion rates
RELEVANCE An important issue for breast cancer survivors receiving chemotherapy is whether there is any advantage to increasing the volume of aerobic exercise or adding resistance exercise to a standard aerobic exercise program If there is an advantage then it is important that breast cancer survivors receive this optimal exercise prescription to maximize their ability to cope with their chemotherapy treatments and maintain their physical function and QoL during this difficult time
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