Combined Strength Training and Functional Endurance Exercise Regimen on Cancer -Related Fatigue and Physical Performance
Condition: Breast Cancer; Fatigue
MeSH terms: Fatigue
Study type: Observational

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.

      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.
    

Intervention name(s): Combined Strength Training and Functional Endurance Exercise; Questionnaire
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; Questionnaires taking approximately 30 minutes total to complete.
Other intervention name(s): Survey; Schwartz Fatigue Scale; Karnofsky Performance Scale; International Physical Activity Questionnaire; IPAQ
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants with breast cancer that will be receiving chemotherapy.
      
Keywords: Breast Cancer; Cancer-Related Fatigue; Fatigue; Exercise; Strength Training; Endurance Exercise; Questionnaire; Survey