Streaming Web-based Exercise At Home: A Pilot Study

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04282967
• Other study ID #: IIT2019-14-SHIRAZIP-SWEAT
• Status: Completed
• Phase: Early Phase 1
• Start date: July 7, 2020
• Est. completion date: March 30, 2023

Study information

• Verified date: April 2023
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 30, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Breast Cancer Female
• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Cedars Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Celina Shirazipour

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attendance	Explore adherence to intervention delivery measured through attendance (frequency of Skype sessions attended and fully completed)	12 weeks
Primary	Adherence	Explore adherence to intervention delivery measured through retention (participation from baseline through final assessment)	12 weeks
Primary	Patient consent	Explore adherence to intervention delivery measured through percentage of patients approached who sign consent	1 day
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Changes in resting heart rate (baseline - mid-study visit)	Changes in resting heart rate between Baseline & mid-study visits	12 weeks
Secondary	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
Secondary	Changes in resting heart rate (baseline - end of study visit)	Changes in resting heart rate between Baseline & end of study visits	24 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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