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Clinical Trials/NCT00421057
NCT00421057CompletedNot Applicable

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

M.D. Anderson Cancer Center1 site in 1 country25 target enrollmentStarted: January 2007Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
25
Locations
1
Primary Endpoint
Patient Fatigue Scores

Study Overview

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.

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 participant's 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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
21 Years to 60 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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 Criteria

  • 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.

Outcomes

Primary Outcomes

Patient Fatigue Scores

Time Frame: Approximately 6 months

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).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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