Recruiting

Exercise vs. Exercise

Sponsor:

OHSU Knight Cancer Institute

Code:

NCT07504835

Conditions

Prostate Carcinoma

Eligibility Criteria

Sex: Male

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Socially enhanced supervised group exercise

Exercise Intervention

Unsupervised independent exercise

Study Details

Brief summary:

This clinical trial tests the impact of different levels of social support on the benefits of exercise in older men with prostate cancer. This trial compares a socially-enhanced supervised group exercise program to a supervised group exercise program with no social enhancement, and an unsupervised home-based program on cancer loneliness, social isolation, mental and physical health in older prostate cancer survivors. All study arms exercise for 6 months and outcomes are measured at baseline, 3 and 6 months. The primary outcome is cancer loneliness with secondary outcomes of mental and physical health.

Conditions

Prostate Carcinoma

Study ID

NCT07504835

Start date

Apr 15, 2026

Status verified date

Apr, 2026

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Sep 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 65+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 65 years of age or older.
  • Diagnosed with histologically confirmed prostate cancer.
  • Completed surgery, chemotherapy, radiation and/or systemic treatment (other than ADT) for cancer > 3 months ago.
  • Experiencing cancer loneliness.
  • Able to ambulate independently; reliance on assistive devices other than a wheelchair is allowed.
  • Willing to be randomized into any of the three study arms and attend 80% or more of planned exercise sessions.
  • Home internet sufficient for videoconferencing.

Exclusion Criteria:

  • Participating in regular group exercise and/or structured resistance training with other cancer survivors (> 1 exercise partner or groups of 3 or more).
  • Health or medical condition that affects movement or neurological disorder, or medication that contraindicates participation in live remote resistance exercise.
  • Cognitive difficulties that preclude answering the survey questions, participating in the intervention, or giving informed consent.
  • Not fluent in English and therefore incapable of answer survey questions, following directions during exercise or performance testing, and providing informed consent in English.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Arm I (Socially enhanced supervised group exercise)

PCS participate in online supervised group exercise training led by a certified exercise instructor over 60 minutes with additional 15-minute pre-exercise social time 3 times weekly over 6 months.

active comparator: Arm II (Supervised group exercise)

PCS participate in online supervised group exercise training led by a certified exercise instructor over 60 minutes 3 times weekly over 6 months.

active comparator: Arm III (Unsupervised independent exercise)

PCS participate in independent exercise training following written manual and/or video over 60 minutes 3 times weekly over 6 months. Men have two one-hour training sessions with the trainer to learn the exercises and then the trainer will check in monthly.

Interventions

Socially enhanced supervised group exercise

Participate in online 15 minute social time prior to participating in a one hour online supervised group exercise session

Exercise Intervention

Participate in a one hour online supervised group exercise session

Unsupervised independent exercise

Participate a one hour exercise session at home by following a written manual and video

Primary outcome measure

  • Cancer loneliness [ Time Frame: Baseline, 3- and 6-months ]

Central Contacts and Locations

Locations

OHSU Knight Cancer Institute

Recruiting

Portland, Oregon, United States, 97239

Contacts

Carolyn Guidarelli, MPH

503-346-0307borsch@ohsu.edu

Principal Investigator:

Kerri Winters-Stone

More Information

Sponsor

OHSU Knight Cancer Institute

Last update posted

May 6, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by OHSU Knight Cancer Institute on 2026-05-06.