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Prostate CancerEarly Phase 1NCT04282967

Streaming Web-based Exercise At Home: A Pilot Study

A Early Phase 1 study testing Exercise in people with Prostate Cancer and Breast Cancer Female, run by Celina Shirazipour at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Prostate Cancer, Breast Cancer Female
What is being tested?
Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
7 Jul 2020to 30 Mar 2023
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

Other trials in United States

About this study

Official title: 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.

Being tested
Exercise
Keywords
Exercise, Breast Cancer Survivor, Prostate Cancer Survivor
Medical subject headings
Prostatic Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseBehavioural

    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.

Study groups in NCT04282967
Study groupRoleWhat they receive
ExerciseExperimentalFor 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.
Receives: Behavioral: Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Attendance

    Explore adherence to intervention delivery measured through attendance (frequency of Skype sessions attended and fully completed)

    Measured: 12 weeks

  2. Adherence

    Explore adherence to intervention delivery measured through retention (participation from baseline through final assessment)

    Measured: 12 weeks

  3. Patient consent

    Explore adherence to intervention delivery measured through percentage of patients approached who sign consent

    Measured: 1 day

  4. 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)

    Measured: 12 weeks

Secondary outcomes (13)

  1. 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.

    Measured: 12 weeks

  2. 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.

    Measured: 12 weeks

  3. 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.

    Measured: 24 weeks

  4. 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.

    Measured: 12 weeks

  5. 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.

    Measured: 12 weeks

  6. 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.

    Measured: 24 weeks

  7. Changes in resting heart rate (baseline - mid-study visit)

    Changes in resting heart rate between Baseline \& mid-study visits

    Measured: 12 weeks

  8. Changes in resting heart rate (mid-study visit - end of study visit)

    Changes in resting heart rate between mid-study \& end of study visits

    Measured: 12 weeks

  9. Changes in resting heart rate (baseline - end of study visit)

    Changes in resting heart rate between Baseline \& end of study visits

    Measured: 24 weeks

  10. 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).

    Measured: 12 weeks

  11. 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).

    Measured: 12 weeks

  12. 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).

    Measured: 24 weeks

  13. Subjective impact

    Subjective impact of exercise intervention as measured by changes in participant-reported rating of exercise self-efficacy and intentions to remain active

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2020
  2. Study start7 Jul 2020
  3. Primary completion30 Mar 2023
  4. Study completion30 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04282967
Sponsor's protocol ID
IIT2019-14-SHIRAZIP-SWEAT
Status last verified
Apr 2023
First submitted
20 Feb 2020
Last updated
11 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Exercise in people with Prostate Cancer and Breast Cancer Female, run by Celina Shirazipour at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Attendance (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04282967.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2023.

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Streaming Web-based Exercise At Home: A Pilot Study | AzTrials