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Completed

NCT Number: NCT04282967

Streaming Web-based Exercise At Home: A Pilot Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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). Patients currently on active surveillance are eligible even if they have not received prior anti-cancer treatment.
  • 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 modified 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).

Treatment and study plan

Exercise

Behavioral

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Celina Shirazipour

Other

Registry information

Official study title

IIT2019-14-SHIRAZIP-SWEAT: Streaming Web-based Exercise At Home: A Pilot Study

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 25, 2020
Registry last updated
Apr 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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