Streaming Web-based Exercise At Home: A Pilot Study

NCT04282967 | Completed Early Phase 1 DMC

• 1 other identifier: IIT2019-14-SHIRAZIP-SWEAT
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Keywords

Exercise; Breast Cancer Survivor; Prostate Cancer Survivor

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (13)

• Changes in oxygen uptake (baseline - mid-study visit)

  12 weeks

• Changes in oxygen uptake (mid-study visit - end of study visit)

  12 weeks

• Changes in oxygen uptake (baseline - end of study visit)

  24 weeks

• Changes in strength test (baseline - mid-study visit)

  12 weeks

• Changes in strength test (mid-study visit - end of study visit)

  12 weeks

Study Arms (1)

Exercise

EXPERIMENTAL

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

Interventions

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.

Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Celina Shirazipour: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Celina Shirazipour, PhD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 20, 2020
• First Posted: February 25, 2020
• Study Start: July 7, 2020
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2023
• Last Updated: April 11, 2023

Record last verified: 2023-04

Locations

US (1)