Recruiting

Home Exercise Technology

Sponsor:

University of Utah

Code:

NCT07032584

Conditions

Prostate Cancer

Metastatic Prostate Cancer

Androgen Deprivation Therapy

Eligibility Criteria

Sex: Male

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Telerehabilitation Intervention

Study Details

Brief summary:

People with prostate cancer may have a decreased quality of life due to the cancer itself and due to a lifesaving cancer treatment. Physical therapy, including regular exercise, helps patients with cancer to reduce disease symptoms and improve their quality of life. However, cancer rehabilitation programs in rural areas are not readily available and may require constant travel and significant financial resources, which may limit access to these services on a continuous basis.

Technology can allow patients residing in rural areas to exercise at home under the supervision of their rehabilitation team. However, it is unclear how effective this approach is. This research team will conduct a clinical trial in which half of the randomly chosen participants receiving hormonal prostate cancer therapy will use this new technology to exercise at home. Another half - will exercise at home without this new technology. After six months, the study will compare the quality of life and cancer symptoms in these two groups.

The investigators hope that this study will demonstrate that the patients who were helped by the new technology to exercise at home will have better fitness, fewer symptoms, and better quality of life. If the study demonstrates this in this project, other patients with cancer residing in rural areas will be able to take advantage of this technology. This approach can be extended to people with different diseases who have difficulties accessing medical care in rural areas to undergo required physical, cognitive, and occupational rehabilitation, and improve their quality of life.

Conditions

Prostate Cancer

Metastatic Prostate Cancer

Androgen Deprivation Therapy

Study ID

NCT07032584

Start date

May 27, 2025

Status verified date

Jul, 2025

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age 21 years or older
2. Confirmed diagnosis of prostate cancer
3. Men receiving standard-of-care ADT either for high-risk, locally advanced prostate cancer or as a part of multicomponent management of metastatic prostate cancer;
4. Residing in a rural community defined by the Rural-Urban Commuting Area (RUCA) codes from the Federal Office of Rural Health Policy (4 and higher).

Exclusion Criteria:

1. Have unstable angina, uncontrolled hypertension, recent myocardial infarction, pacemakers, painful or unstable bony metastases, or recent skeletal fractures.
2. Are engaged in a regular exercise rehabilitation program.
3. Have relocation plans within the next 6 months
4. Participate in another clinical trial related to prostate cancer or rehabilitation. The patients will also be required to have a working telephone line in their home or a cell phone.

Study Design

Enrollment

74 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Telerehabilitation Intervention

Participants in the Telerehabilitation Intervention group (TR) will receive a comprehensive baseline examination conducted by the blinded assessment team. They will also be evaluated by the clinical PT who will prescribe an individualized exercise plan and train them how to perform the exercises. Patients will be mailed exercise equipment (portable bike, elastic bands, pulse oximeter, and activity tracker) with the necessary instructions. Additionally, the TR group will also receive a touchscreen tablet for computer-mediated support in following their individualized exercise plans at their homes daily. The tablet will contain multimedia instructional materials on how to set up and use the telerehab unit.

other: Best Available Care

Participants in the Best Available Care (BAC) group will receive a comprehensive baseline examination conducted by the blinded assessment team. They will also be evaluated by the clinical PT who will prescribe an individualized exercise plan and train them how to perform the exercises. Patients will be mailed exercise equipment (portable bike, elastic bands, pulse oximeter, and activity tracker) with the necessary instructions.

Interventions

Telerehabilitation Intervention

TheTelerehabilitation Intervention (TR) group utilizes a touchscreen tablet equipped with a computer-guided rehabilitation program that provides ongoing support and feedback for home-based rehabilitation.

Primary outcome measure

  • Functional Assessment of Cancer Therapy-Prostate (FACT-P) [ Time Frame: up to 6 months from baseline ]

Central Contacts and Locations

Locations

University of Utah Huntsman Cancer Institute

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

More Information

Sponsor

University of Utah

Last update posted

Aug 1, 2025

Last verified

Jul, 2025

Keywords

  • Telerehabilitation
  • Rural Health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Utah on 2025-08-01.