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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00421057
First received: January 9, 2007
Last updated: July 27, 2012
Last verified: July 2012
  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: Observational Model: Case-Only
Time Perspective: 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:


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

Primary Outcome Measures:
  • Patient Fatigue Scores [ Time Frame: Approximately 6 months ] [ Designated as safety issue: No ]
    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).


Enrollment: 25
Study Start Date: January 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
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.
Other Names:
  • Survey
  • Schwartz Fatigue Scale
  • Karnofsky Performance Scale
  • International Physical Activity Questionnaire
  • IPAQ

  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 Criteria:

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

Exclusion Criteria:

  1. Exclusion criteria include presence of concomitant major health problems in which an exercise regimen is contraindicated (e.g. cardiac, pulmonary, and orthopedic)
  2. 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.
  3. Women who have had breast reconstructive surgery.
  4. Men diagnosed with breast cancer.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00421057     History of Changes
Other Study ID Numbers: 2006-0309
Study First Received: January 9, 2007
Last Updated: July 27, 2012
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

Additional relevant MeSH terms:
Breast Neoplasms
Fatigue
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 28, 2014