Streaming Web-based Exercise At Home: A Pilot Study

IIT2019-14-SHIRAZIP-SWEAT: 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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer; Breast Cancer Female
• Intervention / Treatment: Behavioral: Exercise

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Chris Waring; Phone Number: 424-315-2215; Email: Christopher.Waring@cshs.org

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attendance	Explore adherence to intervention delivery measured through attendance (frequency of Skype sessions attended and fully completed)	12 weeks
Adherence	Explore adherence to intervention delivery measured through retention (participation from baseline through final assessment)	12 weeks
Patient consent	Explore adherence to intervention delivery measured through percentage of patients approached who sign consent	1 day
Manipulation check	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)	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in oxygen uptake (baseline - mid-study visit)	Change in vO2 submax measurement (rate of oxygen uptake during exercise) between baseline & mid-study visits as measured by Bruce submaximal treadmill test.	12 weeks
Changes in oxygen uptake (mid-study visit - end of study visit)	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.	12 weeks
Changes in oxygen uptake (baseline - end of study visit)	Change in vO2 submax measurement (rate of oxygen uptake during exercise) between baseline & end of study visits as measured by Bruce submaximal treadmill test.	24 weeks
Changes in strength test (baseline - mid-study visit)	Change in muscle strength measurement between baseline & mid-study visits as measured by grip strength test and leg press.	12 weeks
Changes in strength test (mid-study visit - end of study visit)	Change in muscle strength measurement between mid-study & end of study visits as measured by grip strength test and leg press.	12 weeks
Changes in strength test (baseline - end of study visit)	Change in muscle strength measurement between baseline & end of study visits as measured by grip strength test and leg press.	24 weeks
Changes in resting heart rate (baseline - mid-study visit)	Changes in resting heart rate between Baseline & mid-study visits	12 weeks
Changes in resting heart rate (mid-study visit - end of study visit)	Changes in resting heart rate between mid-study & end of study visits	12 weeks
Changes in resting heart rate (baseline - end of study visit)	Changes in resting heart rate between Baseline & end of study visits	24 weeks
Changes in body composition (baseline - mid-study visit)	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).	12 weeks
Changes in body composition (mid-study visit - end of study visit)	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 weeks
Changes in body composition (baseline - end of study visit)	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).	24 weeks
Subjective impact	Subjective impact of exercise intervention as measured by changes in participant-reported rating of exercise self-efficacy and intentions to remain active	24 weeks

Collaborators and Investigators

• Sponsor: Celina Shirazipour
• Investigators: Principal Investigator: Celina Shirazipour, PhD, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2020
• Primary Completion (Actual): March 30, 2023
• Study Completion (Actual): March 30, 2023

Study Registration Dates

• First Submitted: February 20, 2020
• First Submitted That Met QC Criteria: February 21, 2020
• First Posted (Actual): February 25, 2020

Study Record Updates

• Last Update Posted (Actual): April 11, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Exercise; Breast Cancer Survivor; Prostate Cancer Survivor
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: IIT2019-14-SHIRAZIP-SWEAT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No