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

NCT00421057 | Completed DMC

• 1 other identifier: 2006-0309
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Fatigue

Keywords

Breast Cancer; Cancer-Related Fatigue; Fatigue; Exercise; Strength Training; Endurance Exercise; Questionnaire; Survey

Outcome Measures

Primary Outcomes (1)

• Patient Fatigue Scores

  Self-reported score that measures subjective perceptions of fatigue in which respondents rate their experience of feeling tired. It ranges from 1 (not at all) to 5 (extremely) and describes discomforts of cancer related fatigue in four dimensions (physical, mental, emotional, and temporal) (Schwartz and Meek, 1999).

  Approximately 6 months

Study Arms (2)

Exercise Group

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

Behavioral: Combined Strength Training and Functional Endurance Exercise

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

Interventions

Combined Strength Training and Functional Endurance Exercise BEHAVIORAL

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.

Exercise Group

Questionnaire BEHAVIORAL

Questionnaires taking approximately 30 minutes total to complete.

Also known as: Survey, Schwartz Fatigue Scale, Karnofsky Performance Scale, International Physical Activity Questionnaire, IPAQ

Nonexercise Group

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants with breast cancer that will be receiving chemotherapy.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

U.T. M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Breast Neoplasms; Fatigue; Motor Activity

Interventions

Surveys and Questionnaires; Karnofsky Performance Status

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Severity of Illness Index; Patient Acuity; Health Status Indicators; Health Surveys

Study Officials

• Geneva Caldwell, MSN, RN

  U.T. M.D. Anderson Cancer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2007
• First Posted: January 11, 2007
• Study Start: January 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: July 31, 2012

Record last verified: 2012-07

Locations

US (1)