Streaming Web-based Exercise At Home: A Pilot Study

April 10, 2023 updated by: Celina Shirazipour

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Attendance
Time Frame: 12 weeks
Explore adherence to intervention delivery measured through attendance (frequency of Skype sessions attended and fully completed)
12 weeks
Adherence
Time Frame: 12 weeks
Explore adherence to intervention delivery measured through retention (participation from baseline through final assessment)
12 weeks
Patient consent
Time Frame: 1 day
Explore adherence to intervention delivery measured through percentage of patients approached who sign consent
1 day
Manipulation check
Time Frame: 12 weeks
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in oxygen uptake (baseline - mid-study visit)
Time Frame: 12 weeks
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)
Time Frame: 12 weeks
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)
Time Frame: 24 weeks
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)
Time Frame: 12 weeks
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)
Time Frame: 12 weeks
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)
Time Frame: 24 weeks
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)
Time Frame: 12 weeks
Changes in resting heart rate between Baseline & mid-study visits
12 weeks
Changes in resting heart rate (mid-study visit - end of study visit)
Time Frame: 12 weeks
Changes in resting heart rate between mid-study & end of study visits
12 weeks
Changes in resting heart rate (baseline - end of study visit)
Time Frame: 24 weeks
Changes in resting heart rate between Baseline & end of study visits
24 weeks
Changes in body composition (baseline - mid-study visit)
Time Frame: 12 weeks
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)
Time Frame: 12 weeks
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)
Time Frame: 24 weeks
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
Time Frame: 24 weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Celina Shirazipour

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Celina Shirazipour, PhD, Cedars-Sinai Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 7, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 25, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 11, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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