Prospective Study of EXErcise Regimens After Treatment for Breast Cancer for Hypertrophy and Conditioning

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age20-89
SponsorAllegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

About this trial

This study investigates the impact of four standard of care, monitored group exercise regimens (resistance training) on conditioning and hypertrophy in women previously treated for breast cancer. The study will compare two conditioning regimens (6-12-25 and 8x8) and two hypertrophy regimens (5/5/5 cluster sets and double training) to assess changes in VO2 max, muscle mass, and fat mass.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 20-89 years

Women prescribed exercise as a Standard of Care

Women with a biopsy proven diagnosis of ductal carcinoma in situ (DCIS) or invasive carcinoma of the breast

Women must have undergone treatment for breast cancer, including one or more of the following: surgery, radiation therapy, chemotherapy, immunotherapy, or hormonal therapy.

Disqualifiers

Any current treatment with cytotoxic chemotherapy for breast cancer

Inability to safely engage in group sessions of resistance training as deemed by study Pl

Severe arthritic, joint, cardiovascular, or musculoskeletal condition deemed by Pl to be unsafe to engage in resistance training

Beta blocker or GLP-1 inhibitor medications

Trial population

Participants will be recruited via convenience sampling from the Study Investigators' practice patient population, referrals from other physicians' practices, or identifiable medical record review (e.g., EPIC).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 6-12-25 Training Regimen

    Other intervention

    A conditioning regimen involving three exercises performed consecutively with minimal rest. Includes 4-6 repetitions at 4-0-1-0 tempo, 10-12 repetitions at 3-0-1-0 tempo, and 20-25 repetitions at 2-0-1-0 tempo.

  • 8x8 Training Regimen

    Other intervention

    A conditioning regimen optimizing high volume with short rest periods. Six exercises are performed consecutively with a 2-0-1-0 tempo and no rest between sets.

  • 5/5/5 Cluster Set Training Regimen

    Other intervention

    A hypertrophy regimen where an individual performs 5 repetitions at a tempo of 4 seconds during the eccentric movement of the exercise, while performing the concentric motion in 1 second then resting for 20 seconds and repeating the sequence two additional times to total three clusters of 5 repetitions.

  • Double Training Regimen

    Other intervention

    A hypertrophy regimen adding an additional set of lesser repetitions for a specified exercise at the end of a tri-set of exercises.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Change in VO2 max

Change in maximal oxygen consumption (VO2 max) measured during and after each exercise regimen.

Time frame
Measured monthly during the 5-month exercise program at weeks 4, 8, 12, 16, and 20.
2

Change in Muscle and Fat Mass

Change in muscle mass and fat mass in pounds as measured by InBody 970.

Time frame
Baseline, at the completion of the 5-month exercise program (Week 20), and monthly during the exercise program at weeks 4, 8, 12, and 16.
3

Change in Muscle and Fat Mass

Change in muscle mass and fat mass in pounds as measured by ultrasound.

Time frame
Baseline, at the completion of the 5-month exercise program (Week 20), and monthly during the exercise program at weeks 4, 8, 12, and 16.

Secondary outcomes

1

Change in Hand Grip Strength

Measurement of hand grip strength using a dynamometer to assess upper body strength and function.

Time frame
Baseline, at the completion of the 5-month exercise program (Week 20), and monthly during the exercise program at weeks 4, 8, 12, and 16.
2

Change in Psychology Questionnaire Scores

Assessment of psychological well-being, including confidence, motivation (intrinsic \& extrinsic), anxiety, and depression, using a Psychological Screen for Strength Training questionnaire. The responses to the variables will be calculated. The rating scale will be calculated 0-3. Not at all (0), some of the time (1), most of the time (2), and all the time (3).

Time frame
Baseline, at the completion of the 5-month exercise program (Week 20), and monthly during the exercise program at weeks 4, 8, 12, and 16.

Other outcomes

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