Combined Strength Training and Functional Endurance Exercise Regimen on Cancer -Related Fatigue and Physical Performance - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00421057

Purpose

Primary Objective:

Determine if a specific exercise regimen (combined strength training/functional 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 training/functional 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 training/functional endurance) increases endurance in women with breast cancer while undergoing adjuvant or neoadjuvant chemotherapy as compared to a control group.

Condition	Intervention
Breast Cancer Fatigue	Behavioral: Combined Strength Training and Functional Endurance Exercise Behavioral: Questionnaire

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	The Effects of Combined Strength Training and Functional Endurance Exercise Regimen on Cancer-Related Fatigue and Physical Performance

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Exercise and Physical Fitness

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To find out if exercise (specific strength training and walking) can help reduce fatigue (decreased strength and energy) that is caused by cancer and cancer treatment. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Researchers want to try to find ways to help improve patients' ability to perform day-to-day physical activities. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	58
Study Start Date:	January 2007
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Exercise group: Taught to perform a specific regimen for strength-training and walking exercises.	Behavioral: Combined Strength Training and Functional Endurance Exercise Participants will be taught to stretch a Theraband as far as your arms or legs can stretch and the proper posture for walking for exercise. The Estimated Timed-Get-Up and Go test (ETGUPGo) and a 6-minute walk test will be performed to check your level of fatigue and physical ability. Behavioral: Questionnaire Questionnaires taking approximately 30 minutes total to complete.
2 Nonexercise group: Follow usual routines of standard care but not taught to perform a specific regimen for strength-training and walking exercises; will keep record of any exercises done that are not a part of this study.	Behavioral: Questionnaire Questionnaires taking approximately 30 minutes total to complete.

Groups/Cohorts

Assigned Interventions

1

Exercise group: Taught to perform a specific regimen for strength-training and walking exercises.

Behavioral: Combined Strength Training and Functional Endurance Exercise

Participants will be taught to stretch a Theraband as far as your arms or legs can stretch and the proper posture for walking for exercise. The Estimated Timed-Get-Up and Go test (ETGUPGo) and a 6-minute walk test will be performed to check your level of fatigue and physical ability.

Behavioral: Questionnaire

Questionnaires taking approximately 30 minutes total to complete.

2

Nonexercise group: Follow usual routines of standard care but not taught to perform a specific regimen for strength-training and walking exercises; will keep record of any exercises done that are not a part of this study.

Behavioral: Questionnaire

Questionnaires taking approximately 30 minutes total to complete.

Show Detailed Description

Eligibility

Ages Eligible for Study:	21 Years to 60 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Participants with breast cancer that will be receiving chemotherapy.

Criteria

Inclusion:

Subjects must have a clinical diagnosis of breast cancer (Stages I - III),
be between the ages of 21 and 60 years;
may have undergone definitive surgical procedure (lumpectomy or mastectomy), and
be scheduled to receive any chemotherapy/hormonal blocker regimen that is appropriate for treatment of breast cancer (neoadjuvant or adjuvant)
approval of the Oncologist responsible for overseeing the cancer treatment plan for the patient to participate in this study.

Exclusion:

Exclusion criteria include presence of concomitant major health problems in which an exercise regimen is contraindicated (e.g. cardiac, pulmonary, and orthopedic)
Currently participating in a structured exercise program which is defined as a regular walking, stretching, and or dance type exercise that is performed at least 30 minutes or greater each time and more than 3 times per week.
Women who have had breast reconstructive surgery.
Men diagnosed with breast cancer.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00421057

Locations

United States, Texas
U.T. M.D. Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Geneva Caldwell, MSN, RN

U.T. M.D. Anderson Cancer

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Geneva Caldwell, MSN, RN/Dir, Clinical Nursing )
Study ID Numbers:	2006-0309
Study First Received:	January 9, 2007
Last Updated:	September 29, 2008
ClinicalTrials.gov Identifier:	NCT00421057 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Breast Cancer
Cancer-Related Fatigue
Fatigue
Exercise

Strength Training
Endurance Exercise
Questionnaire
Survey

Study placed in the following topic categories:

Signs and Symptoms
Fatigue
Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Signs and Symptoms
Neoplasms
Neoplasms by Site
Fatigue

Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on September 09, 2009