Streaming Web-based Exercise At Home: A Pilot Study

NCT ID: NCT04282967

Last Updated: 2023-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-07
• Study Completion Date: 2023-03-30

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.

Conditions

Prostate Cancer; Breast Cancer Female

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celina Shirazipour

OTHER

Sponsor Role: lead

Responsible Party

Celina Shirazipour

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Celina Shirazipour, PhD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars Sinai Medical Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

IIT2019-14-SHIRAZIP-SWEAT

Identifier Type: -

Identifier Source: org_study_id