Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00421057
Status:
COMPLETED
Last Update Posted:
2012-07-31
First Post:
2007-01-09
Brief Title:
Combined Strength Training and Functional Endurance Exercise Regimen on Cancer -Related Fatigue and Physical Performance
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
The Effects of Combined Strength Training and Functional Endurance Exercise Regimen on Cancer-Related Fatigue and Physical Performance
Status:
COMPLETED
Status Verified Date:
2012-07
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:
Primary Objective
-Determine if a specific exercise regimen combined strength trainingfunctional endurance reduces the level of fatigue among women with breast cancer while undergoing adjuvant or neoadjuvant chemotherapy treatment as compared to a control group
Secondary Objectives
Determine if a specific exercise regimen combined strength trainingfunctional endurance increases the overall ability to perform daily physical activities ADLs among women with breast cancer while undergoing adjuvant or neoadjuvant chemotherapy treatment as compared to a control group
Determine if a specific exercise regimen combined strength training functional endurance increases mobility in women with breast cancer while undergoing adjuvant or neoadjuvant chemotherapy treatment as compared to a control group
Determine if a specific exercise regimen combined strength trainingfunctional endurance increases endurance in women with breast cancer while undergoing adjuvant or neoadjuvant chemotherapy as compared to a control group
-Determine if a specific exercise regimen combined strength trainingfunctional endurance reduces the level of fatigue among women with breast cancer while undergoing adjuvant or neoadjuvant chemotherapy treatment as compared to a control group
Secondary Objectives
Determine if a specific exercise regimen combined strength trainingfunctional endurance increases the overall ability to perform daily physical activities ADLs among women with breast cancer while undergoing adjuvant or neoadjuvant chemotherapy treatment as compared to a control group
Determine if a specific exercise regimen combined strength training functional endurance increases mobility in women with breast cancer while undergoing adjuvant or neoadjuvant chemotherapy treatment as compared to a control group
Determine if a specific exercise regimen combined strength trainingfunctional endurance increases endurance in women with breast cancer while undergoing adjuvant or neoadjuvant chemotherapy as compared to a control group
Detailed Description:
Cancer-related fatigue has been described as the most common and troubling side effect of cancer and cancer treatment Researchers want to see if a strength-training and walking exercise regimen may help reduce severe fatigue and increase patients ability to perform activities of daily living
If you agree to take part in this study you will complete a questionnaire provide contact information and participate in 1 of 2 groups For the questionnaire you will be asked information about your age ethnic origin marital status education exercise habits and cancer diagnosis It should take about 5 minutes to complete For the contact information you will be asked to provide the name address and telephone number of someone to call in case of an emergency
After completing the questionnaire and providing the contact information you will be randomly assigned as in the toss of a coin to 1 of 2 groups Participants in the exercise group will be taught to perform a specific regimen for strength-training and walking exercises Participants in the nonexercise group will follow the usual routines of standard care but will not be taught to perform a specific regimen for strength-training and walking exercises Participants in the nonexercise group will be asked to keep a record of any exercises that are done for the participants personal regimen that are not a part of this study You will have an equal chance of being assigned to either group
All participants in this study will be asked to complete questionnaires the Schwartz Fatigue Scale Karnofsky Performance Scale and the International Physical Activity Questionnaire IPAQ in the Breast Center Clinic before beginning chemotherapy treatment The Schwartz Fatigue Scale and IPAQ will also be completed after chemotherapy treatment All of these questionnaires will be used to provide information about your physical activities and how much time you spend doing them It should take about 25-30 minutes to complete all 3 questionnaires
No matter what group you are in after these questionnaires are completed a physical therapist will then escort you to the exercise room located in the Physical Therapy and Rehabilitation Clinic The therapist will perform a lymphedema excess fluid collection evaluation that will involve measuring the size of your arms and hands by placing a tape measure around your arms and hands at 5 different points The lymphedema evaluation will be done at each clinic visit when you come in for chemotherapy and 2 weeks after completing your therapy You will also be asked to complete exercise testing the Estimated Timed-Get-Up and Go test ETGUPGo and a 6-minute walk test to check your level of fatigue and physical ability This exercise testing will be performed before you begin chemotherapy and within 2 weeks after you finish your last chemotherapy treatment The exercise testing will be done after your chemotherapy treatment so that researchers can compare your level of fatigue and physical performance to what you were experiencing before your therapy began
The ETGUPGo test will measure how fast you can rise from a chair walk about 4 yards turnaround and return to the chair and sit down For the 6-minute walk test the therapist will ask you to walk around in the exercise room at your own pace while the therapist counts the total time you were able to walk Two 2 weeks after you have finished all of your treatments you will re-take the Schwartz Fatigue Scale Karnofsky Scale IPAQ ETGUPGo and 6-minute walk test Your exercise testing will be done in private which means that no one other than the study staff will be allowed to enter the room while you are being tested
If you are assigned to the group that will have a specific exercise regimen you will be taught a strengthening and walking exercise For the strengthening regimen you will be taught to stretch a Theraband material that looks like a big rubber band as far as your arms or legs can stretch You will be taught to perform this exercise at home You will be able to look at pictures of these exercises in a booklet that will be provided to you You will be asked to perform these exercises 3-5 times per week For the walking regimen you will be taught the proper posture for walking for exercise You must walk at least once per day but otherwise you may walk as often and as long as you feel like
You will also have exercise testing The therapist will measure the length of your arms and legs to see how much force it takes for you to stretch the rubber band beyond the length of your arms and legs The therapist will test your current muscle strength by asking you to sit and rise from a chair walk a certain distance and return to the chair You will also be asked to walk a certain distance until you get tired The therapist will record how much time it takes you to complete both exercises strengthening and walking
After you begin the exercises at home the research nurse will call you every 2 weeks and ask you how many times you performed the strengthening exercises throughout the week as well as the average amount of time you walked each day The phone call should last about 10-15 minutes each time You will be asked to check the box on an exercise calendar that will be provided to you showing which exercises you were able to perform each day
All exercise testing will be given on the day of your routine visits to the clinic
Your participation will be complete in this study after you perform your last exercise testing about 2 weeks after your last chemotherapy treatment
This is an investigational study However if you begin to experience some emotional distress that is directly related to this study you may be referred for professional counseling here at M D Anderson in the Social Work Department The social services staff will be available to assist you with the referral outside of the M D Anderson system Up to 58 patients will take part in this study All will be enrolled at M D Anderson
If you agree to take part in this study you will complete a questionnaire provide contact information and participate in 1 of 2 groups For the questionnaire you will be asked information about your age ethnic origin marital status education exercise habits and cancer diagnosis It should take about 5 minutes to complete For the contact information you will be asked to provide the name address and telephone number of someone to call in case of an emergency
After completing the questionnaire and providing the contact information you will be randomly assigned as in the toss of a coin to 1 of 2 groups Participants in the exercise group will be taught to perform a specific regimen for strength-training and walking exercises Participants in the nonexercise group will follow the usual routines of standard care but will not be taught to perform a specific regimen for strength-training and walking exercises Participants in the nonexercise group will be asked to keep a record of any exercises that are done for the participants personal regimen that are not a part of this study You will have an equal chance of being assigned to either group
All participants in this study will be asked to complete questionnaires the Schwartz Fatigue Scale Karnofsky Performance Scale and the International Physical Activity Questionnaire IPAQ in the Breast Center Clinic before beginning chemotherapy treatment The Schwartz Fatigue Scale and IPAQ will also be completed after chemotherapy treatment All of these questionnaires will be used to provide information about your physical activities and how much time you spend doing them It should take about 25-30 minutes to complete all 3 questionnaires
No matter what group you are in after these questionnaires are completed a physical therapist will then escort you to the exercise room located in the Physical Therapy and Rehabilitation Clinic The therapist will perform a lymphedema excess fluid collection evaluation that will involve measuring the size of your arms and hands by placing a tape measure around your arms and hands at 5 different points The lymphedema evaluation will be done at each clinic visit when you come in for chemotherapy and 2 weeks after completing your therapy You will also be asked to complete exercise testing the Estimated Timed-Get-Up and Go test ETGUPGo and a 6-minute walk test to check your level of fatigue and physical ability This exercise testing will be performed before you begin chemotherapy and within 2 weeks after you finish your last chemotherapy treatment The exercise testing will be done after your chemotherapy treatment so that researchers can compare your level of fatigue and physical performance to what you were experiencing before your therapy began
The ETGUPGo test will measure how fast you can rise from a chair walk about 4 yards turnaround and return to the chair and sit down For the 6-minute walk test the therapist will ask you to walk around in the exercise room at your own pace while the therapist counts the total time you were able to walk Two 2 weeks after you have finished all of your treatments you will re-take the Schwartz Fatigue Scale Karnofsky Scale IPAQ ETGUPGo and 6-minute walk test Your exercise testing will be done in private which means that no one other than the study staff will be allowed to enter the room while you are being tested
If you are assigned to the group that will have a specific exercise regimen you will be taught a strengthening and walking exercise For the strengthening regimen you will be taught to stretch a Theraband material that looks like a big rubber band as far as your arms or legs can stretch You will be taught to perform this exercise at home You will be able to look at pictures of these exercises in a booklet that will be provided to you You will be asked to perform these exercises 3-5 times per week For the walking regimen you will be taught the proper posture for walking for exercise You must walk at least once per day but otherwise you may walk as often and as long as you feel like
You will also have exercise testing The therapist will measure the length of your arms and legs to see how much force it takes for you to stretch the rubber band beyond the length of your arms and legs The therapist will test your current muscle strength by asking you to sit and rise from a chair walk a certain distance and return to the chair You will also be asked to walk a certain distance until you get tired The therapist will record how much time it takes you to complete both exercises strengthening and walking
After you begin the exercises at home the research nurse will call you every 2 weeks and ask you how many times you performed the strengthening exercises throughout the week as well as the average amount of time you walked each day The phone call should last about 10-15 minutes each time You will be asked to check the box on an exercise calendar that will be provided to you showing which exercises you were able to perform each day
All exercise testing will be given on the day of your routine visits to the clinic
Your participation will be complete in this study after you perform your last exercise testing about 2 weeks after your last chemotherapy treatment
This is an investigational study However if you begin to experience some emotional distress that is directly related to this study you may be referred for professional counseling here at M D Anderson in the Social Work Department The social services staff will be available to assist you with the referral outside of the M D Anderson system Up to 58 patients will take part in this study All will be enrolled at M D Anderson
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