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Streaming Web-based Exercise At Home: A Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04282967
Recruitment Status : Not yet recruiting
First Posted : February 25, 2020
Last Update Posted : May 21, 2020
Sponsor:
Information provided by (Responsible Party):
Celina Shirazipour, Cedars-Sinai Medical Center

Brief Summary:
This is a single-arm pilot study to evaluate the use of web-based video conferencing as a method of exercise training delivery. This study will include 10 female breast cancer survivors and 10 male prostate cancer survivors. For the first 12 weeks on study (Part 1), participants will train with an exercise physiologist (EP) for 150 minutes/week. This training will be delivered by web-based video conferencing. For the next 12 weeks (Part 2), participants will be instructed to do patient-directed exercise.

Condition or disease Intervention/treatment Phase
Prostate Cancer Breast Cancer Female Behavioral: Exercise Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: IIT2019-14-SHIRAZIP-SWEAT: Streaming Web-based Exercise At Home: A Pilot Study
Estimated Study Start Date : August 1, 2020
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise
For the first 12 weeks on study (Part 1), participants will train with an exercise physiologist (EP) for 150 minutes/week. This training will be delivered by web-based video conferencing. For the next 12 weeks (Part 2), participants will be instructed to do patient-directed exercise.
Behavioral: Exercise
For the first 12 weeks on study (Part 1), participants will train with an exercise physiologist for 150 minutes/week. This training will be delivered by web-based video conferencing. For the next 12 weeks (Part 2), participants will be instructed to do patient-directed exercise.




Primary Outcome Measures :
  1. Attendance [ Time Frame: 12 weeks ]
    Explore adherence to intervention delivery measured through attendance (frequency of Skype sessions attended and fully completed)

  2. Adherence [ Time Frame: 12 weeks ]
    Explore adherence to intervention delivery measured through retention (participation from baseline through final assessment)

  3. Patient consent [ Time Frame: 1 day ]
    Explore adherence to intervention delivery measured through percentage of patients approached who sign consent

  4. Manipulation check [ Time Frame: 12 weeks ]
    Explore adherence to intervention delivery measured through scores on manipulation check after each session (2 questions asked by exercise physiologist on sound and visual clarity of the session)


Secondary Outcome Measures :
  1. Changes in oxygen uptake (baseline - mid-study visit) [ Time Frame: 12 weeks ]
    Change in vO2 submax measurement (rate of oxygen uptake during exercise) between baseline & mid-study visits as measured by Bruce submaximal treadmill test.

  2. Changes in oxygen uptake (mid-study visit - end of study visit) [ Time Frame: 12 weeks ]
    Change in vO2 submax measurement (rate of oxygen uptake during exercise) between mid-study & end of study visits as measured by Bruce submaximal treadmill test.

  3. Changes in oxygen uptake (baseline - end of study visit) [ Time Frame: 24 weeks ]
    Change in vO2 submax measurement (rate of oxygen uptake during exercise) between baseline & end of study visits as measured by Bruce submaximal treadmill test.

  4. Changes in strength test (baseline - mid-study visit) [ Time Frame: 12 weeks ]
    Change in muscle strength measurement between baseline & mid-study visits as measured by grip strength test and leg press.

  5. Changes in strength test (mid-study visit - end of study visit) [ Time Frame: 12 weeks ]
    Change in muscle strength measurement between mid-study & end of study visits as measured by grip strength test and leg press.

  6. Changes in strength test (baseline - end of study visit) [ Time Frame: 24 weeks ]
    Change in muscle strength measurement between baseline & end of study visits as measured by grip strength test and leg press.

  7. Changes in resting heart rate (baseline - mid-study visit) [ Time Frame: 12 weeks ]
    Changes in resting heart rate between Baseline & mid-study visits

  8. Changes in resting heart rate (mid-study visit - end of study visit) [ Time Frame: 12 weeks ]
    Changes in resting heart rate between mid-study & end of study visits

  9. Changes in resting heart rate (baseline - end of study visit) [ Time Frame: 24 weeks ]
    Changes in resting heart rate between Baseline & end of study visits

  10. Changes in body composition (baseline - mid-study visit) [ Time Frame: 12 weeks ]
    Changes in body composition between baseline & mid-study visits as measured by InBody (non-invasive body composition analysis that calculates weight, skeletal muscle mass, fat mass, BMI, and body fat percent using Bio-Electrical Impedance Analysis).

  11. Changes in body composition (mid-study visit - end of study visit) [ Time Frame: 12 weeks ]
    Changes in body composition between mid-study & end of study visits as measured by InBody (non-invasive body composition analysis that calculates weight, skeletal muscle mass, fat mass, BMI, and body fat percent using Bio-Electrical Impedance Analysis).

  12. Changes in body composition (baseline - end of study visit) [ Time Frame: 24 weeks ]
    Change in body composition between baseline & end of study visits as measured by InBody (non-invasive body composition analysis that calculates weight, skeletal muscle mass, fat mass, BMI, and body fat percent using Bio-Electrical Impedance Analysis).

  13. Subjective impact [ Time Frame: 24 weeks ]
    Subjective impact of exercise intervention as measured by changes in participant-reported rating of exercise self-efficacy and intentions to remain active



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male previously diagnosed with prostate cancer or female previously diagnosed with breast cancer.
  • For breast cancer, minimum of 3 months post-active treatment completion. Active treatment includes chemotherapy, biologic therapy, radiation therapy, surgery, and any combination. Long-term hormonal/biologic treatments are acceptable.
  • For prostate cancer, minimum of 3 months post-active treatment completion. Active treatment includes chemotherapy, biologic therapy, radiation therapy, surgery, and any combination. Long-term hormonal/biologic treatments are acceptable, except for androgen receptor-targeted therapies (such as enzalutamide, apalutamide, darolutamide, or abiraterone).
  • Has access to tablet, laptop, or desktop computer with video capabilities connected to the internet with a screen at least 13 inches across.
  • Physically able to complete Bruce submaximal treadmill test, leg strength test, grip strength test, and InBody per patient self-assessment.
  • Physician clearance to participate in this study. Can be done through review of patients' medical records.
  • Ability to read, write, and understand English.
  • Has a chair at home to use for exercise that is not on wheels and has a solid back (not a reclining chair).
  • Ambulatory without assistance.
  • Has a clear 5 x 6-foot space at home in which to exercise.
  • Age >18 years.
  • Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

  • Active treatment planned within the next 6 months. Active treatment includes chemotherapy, biologic therapy, radiation therapy, surgery, and any combination. Long-term hormonal/biologic treatments are acceptable, except for AR-targeted therapies for prostate cancer.
  • Known metastatic disease.
  • Grade 3 or higher peripheral neuropathy.
  • Major surgery within 3 months of baseline visit.
  • Positive pregnancy test for women of child-bearing potential.
  • Answers yes to any question on the Physical Activity Readiness Questionnaire unless study participation is cleared by a physician.
  • Known allergy to Fitbit device.
  • Currently meeting physical activity guidelines (score of >23 on Godin-Shephard Leisure-Time Physical Activity Questionnaire).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04282967


Contacts
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Contact: Laura Lockshon 424-315-2219 laura.lockshon@cshs.org

Locations
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United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Celina Shirazipour
Investigators
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Principal Investigator: Celina Shirazipour, PhD Cedars-Sinai Medical Center
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Responsible Party: Celina Shirazipour, Assistant Professor, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT04282967    
Other Study ID Numbers: IIT2019-14-SHIRAZIP-SWEAT
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: May 21, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Celina Shirazipour, Cedars-Sinai Medical Center:
Exercise
Breast Cancer Survivor
Prostate Cancer Survivor
Additional relevant MeSH terms:
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Prostatic Neoplasms
Neoplasms by Site
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases