GET FIT Prostate: A Randomized Controlled Exercise Trial

PRIMARY OBJECTIVES:

I. To determine and compare the efficacy of tai ji quan training and strength training in
reducing the incidence of falls in prostate cancer survivors on androgen deprivation therapy
(ADT).

SECONDARY OBJECTIVES:

I. To determine and compare the efficacy of tai ji quan training and strength training to
reduce frailty and dysfunction in prostate cancer survivors on ADT.

TERTIARY OBJECTIVES:

I. To determine how well the benefits of tai ji quan and strength interventions persist over
a 6-month period.

OUTLINE:

The study is a 3-group, single-blind, parallel design randomized controlled trial in prostate
cancer survivors treated with ADT. Participants in each study group will attend supervised
1-hr classes, 3 days a week for 6 months.

ARM 1: Tai ji quan, an integrated exercise routine consisting of 8 purposeful movement forms
and a set of therapeutic movements, specifically designed to challenge limits of stability
and train gait patterns, as reflected in movements such as upright trunk positioning,
displacement of body's center of mass over the weight-bearing leg, and step initiation,
locomotion, and termination.

ARM 2: Strength training. Participants wear a weighted vest while performing exercises using
functional movement patterns that challenge balance by using muscle groups and movement
involved in everyday activities (chair rises, 90°squats, side-to-side squats, toe raises,
lunges (forward, lateral, backward, walking), multi-directional step ups).

ARM 3: Stretching control. Participants in the control group will attend a supervised
flexibility program of the same total weekly duration as the experimental arms (e.g., 3,
60-min sessions per week). Control participants will perform a series of whole body
stretching exercises, according to the ACSM guidelines for flexibility training, with a focus
on developing and maintaining a healthy back.

Six Month Follow-Up: Participants will be followed for an additional 6 months after the
6-month supervised intervention stops to track falls (using same monthly report used during
intervention phase). Exercise questionnaires to track participation in home or community
exercise programs and will be collected at the 9- and 12-month time periods.

Inclusion Criteria:

- Diagnosed with histologically confirmed prostate cancer.

- Currently on ADT for >= 6 months OR not currently receiving ADT, but received >=
6-month course within the last 10 years.

- Completed any surgery, radiation or chemotherapy ≥ 6 weeks prior to enrollment and no
concurrent adjuvant therapy other than ADT for prostate cancer

- Meets criteria for having experienced ≥1 fall in the last year (confirmed by
self-report on Health History Questionnaire) or if no falls, meets criteria for slow
TUG time (≥12.0 seconds) OR slow chair stand time (≥10.0 seconds).

Exclusion Criteria:

- Current participation in moderate-vigorous intensity lower-body strength training two
or more times per week for 30 minutes or more or participating in tai chi two or more
times per week for 30 minutes or more.

- Cognitive difficulties that preclude answering the survey questions, participating in
the exercise classes or performance tests, or providing informed consent.

- A medical condition, movement or neurological disorder, or medication use that
contraindicates participation in moderate intensity exercise.

- Not medically cleared for participation in moderate intensity exercise.