Back to resultsStreaming Web-based Exercise At Home: A Pilot Study
Primary Purpose
Prostate Cancer, Breast Cancer Female
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional supportive care trial for Prostate Cancer focused on measuring Exercise, Breast Cancer Survivor, Prostate Cancer Survivor
Eligibility 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). 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).
Sites / Locations
- Cedars Sinai Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Exercise
Arm Description
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.
Outcomes
Primary Outcome Measures
Attendance
Explore adherence to intervention delivery measured through attendance (frequency of Skype sessions attended and fully completed)
Adherence
Explore adherence to intervention delivery measured through retention (participation from baseline through final assessment)
Patient consent
Explore adherence to intervention delivery measured through percentage of patients approached who sign consent
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)
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
Changes in resting heart rate (baseline - mid-study visit)
Changes in resting heart rate between Baseline & mid-study visits
Changes in resting heart rate (mid-study visit - end of study visit)
Changes in resting heart rate between mid-study & end of study visits
Changes in resting heart rate (baseline - end of study visit)
Changes in resting heart rate between Baseline & end of study visits
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).
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).
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).
Subjective impact
Subjective impact of exercise intervention as measured by changes in participant-reported rating of exercise self-efficacy and intentions to remain active
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04282967
Brief Title
Streaming Web-based Exercise At Home: A Pilot Study
Official Title
IIT2019-14-SHIRAZIP-SWEAT: Streaming Web-based Exercise At Home: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
July 7, 2020 (Actual)
Primary Completion Date
March 30, 2023 (Actual)
Study Completion Date
March 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Celina Shirazipour
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Breast Cancer Female
Keywords
Exercise, Breast Cancer Survivor, Prostate Cancer Survivor
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
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 Measure Information:
Title
Attendance
Description
Explore adherence to intervention delivery measured through attendance (frequency of Skype sessions attended and fully completed)
Time Frame
12 weeks
Title
Adherence
Description
Explore adherence to intervention delivery measured through retention (participation from baseline through final assessment)
Time Frame
12 weeks
Title
Patient consent
Description
Explore adherence to intervention delivery measured through percentage of patients approached who sign consent
Time Frame
1 day
Title
Manipulation check
Description
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)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Changes in oxygen uptake (baseline - mid-study visit)
Description
Change in vO2 submax measurement (rate of oxygen uptake during exercise) between baseline & mid-study visits as measured by Bruce submaximal treadmill test.
Time Frame
12 weeks
Title
Changes in oxygen uptake (mid-study visit - end of study visit)
Description
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.
Time Frame
12 weeks
Title
Changes in oxygen uptake (baseline - end of study visit)
Description
Change in vO2 submax measurement (rate of oxygen uptake during exercise) between baseline & end of study visits as measured by Bruce submaximal treadmill test.
Time Frame
24 weeks
Title
Changes in strength test (baseline - mid-study visit)
Description
Change in muscle strength measurement between baseline & mid-study visits as measured by grip strength test and leg press.
Time Frame
12 weeks
Title
Changes in strength test (mid-study visit - end of study visit)
Description
Change in muscle strength measurement between mid-study & end of study visits as measured by grip strength test and leg press.
Time Frame
12 weeks
Title
Changes in strength test (baseline - end of study visit)
Description
Change in muscle strength measurement between baseline & end of study visits as measured by grip strength test and leg press.
Time Frame
24 weeks
Title
Changes in resting heart rate (baseline - mid-study visit)
Description
Changes in resting heart rate between Baseline & mid-study visits
Time Frame
12 weeks
Title
Changes in resting heart rate (mid-study visit - end of study visit)
Description
Changes in resting heart rate between mid-study & end of study visits
Time Frame
12 weeks
Title
Changes in resting heart rate (baseline - end of study visit)
Description
Changes in resting heart rate between Baseline & end of study visits
Time Frame
24 weeks
Title
Changes in body composition (baseline - mid-study visit)
Description
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).
Time Frame
12 weeks
Title
Changes in body composition (mid-study visit - end of study visit)
Description
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).
Time Frame
12 weeks
Title
Changes in body composition (baseline - end of study visit)
Description
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).
Time Frame
24 weeks
Title
Subjective impact
Description
Subjective impact of exercise intervention as measured by changes in participant-reported rating of exercise self-efficacy and intentions to remain active
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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). 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Celina Shirazipour, PhD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Streaming Web-based Exercise At Home: A Pilot Study
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