Home-based Exercise Intervention for Patients With Metastatic Prostate Cancer

To estimate the feasibility of a 12 week, home-based exercise intervention in metastatic castrate resistant prostate cancer (mCPRC) patients undergoing androgen deprivation therapy by reporting the percentage of patients who complete the pre/post testing following the intervention. This was calculated as the number of subjects who completed the trial compared to the total number who completed baseline testing.

Time frame: 12 weeks after baseline testing

Population: All participants in the trial.

To report the level of adherence to the exercise intervention in patients completing pre/post testing. Successful adherence to the program is completion of 75% of all prescribed exercise and will be assessed using wearable technology to track walking and exercise logs to track resistance training adherence. Adherence was determined as the number of exercise sessions attempted/completed over the total number of session prescribed.

Time frame: 12 weeks after baseline testing

Population: This analysis was restricted to subjects who completed the intervention and returned their training logs.

To report changes in cardiopulmonary function following the intervention. Cardiopulmonary function (VO2 peak) will be assessed using a graded exercise test on a treadmill. Patients will begin the test walking slowly on the treadmill and every two minutes, the grade and speed of the treadmill will be increased in a progressive manner until fatigue occurs. Respiratory gases will be collected throughout the test and analyzed using a metabolic cart to determine oxygen utilization and carbon dioxide production. The maximal oxygen uptake that is recorded will be used as a marker of aerobic fitness.

Time frame: 12 weeks after baseline testing

Population: Data from pre vs. post intervention were analyzed using a paired t-test only in subjects who completed all aspects of the trial.

Upper and lower body muscle strength will be assessed using the chest and leg presses. Maximal strength is defined as the highest load (kilograms) that the participant can successfully lift one time. Greater maximal strength is associated with greater physical function and QoL.

Time frame: 12 weeks after baseline testing

Population: Data from pre vs. post intervention were analyzed using a paired t-test only in subjects who completed all aspects of the trial and were tested at the UNC site.

Upper and lower body muscle endurance will be assessed using the chest and leg presses. Muscle endurance is the total number of repetitions completed using 70% of maximal load determined during muscle strength testing (outcome 12). Greater muscle endurance are associated with greater physical function and QoL.

Time frame: 12 weeks after baseline testing

Population: Data from pre vs. post intervention were analyzed using a paired t-test only in subjects who completed all aspects of the trial and were tested at the UNC site.

To report changes in total fat mass following the intervention. Total fat mass will be measured using dual-energy x-ray absorptiometry (DXA) before and after the intervention.

Time frame: 12 weeks after baseline testing

Population: Data from pre vs. post intervention were analyzed using a paired t-test only in subjects who completed all aspects of the trial and completed the body composition scans.

To report changes in total lean mass following the intervention. Total body lean mass will be measured using dual-energy x-ray absorptiometry (DXA) before and after the intervention.

Time frame: 12 weeks after baseline testing

Population: Data from pre vs. post intervention were analyzed using a paired t-test only in subjects who completed all aspects of the trial and the body composition scans.

Upper and lower body muscle strength will be assessed using the chest and leg presses. Maximal strength is defined as the highest load (kilograms) that the participant can successfully lift one time. Greater maximal strength is associated with greater physical function and QoL.

Time frame: 12 weeks after baseline testing

Population: Data from pre vs. post intervention were analyzed using a paired t-test only in subjects who completed all aspects of the trial and were tested at the UNC site.

Upper and lower body muscle endurance will be assessed using the chest and leg presses. Muscle endurance is the total number of repetitions completed using 70% of maximal load determined during muscle strength testing (outcome 12). Greater muscle endurance are associated with greater physical function and QoL.

Time frame: 12 weeks after baseline testing

Population: Data from pre vs. post intervention were analyzed using a paired t-test only in subjects who completed all aspects of the trial and were tested at the UNC site.

Muscle architecture will be analyzed using ultrasound of the vastus lateralis of the dominant leg. All assessments will be completed before and after the intervention to determine the muscle quality. Higher muscle mass and quality are associated with greater muscle strength, physical function, QoL, and mortality. Muscle quality is reported in arbitrary units, where a lower value indicates a higher/better muscle quality.

Time frame: 12 weeks after baseline testing

Population: Data from pre vs. post intervention were analyzed using a paired t-test only in subjects who completed all aspects of the trial and were tested at the UNC site.

Muscle size will be analyzed using ultrasound of the vastus lateralis of the dominant leg. All assessments will be completed before and after the intervention to determine the muscle size. Higher muscle mass and quality are associated with greater muscle strength, physical function, QoL, and mortality.

Time frame: 12 weeks after baseline testing

Population: Data from pre vs. post intervention were analyzed using a paired t-test only in subjects who completed all aspects of the trial and were tested at the University of North Carolina (UNC) site only. Equipment to perform this analysis at the Wake Forest site was not available.

Depression will be measured using the Hospital Anxiety and Depression Scale, a concise, self-administered 1 page form that categorizes anxiety and depression. The total score goes from 0-21, and scores are categorized from minimal to severe depression/anxiety. Higher total scores indicate greater levels of depression.

Time frame: 12 weeks after baseline testing

Population: Data from pre vs. post intervention were analyzed using a paired t-test only in subjects who completed all aspects of the trial and returned the questionnaires.

Depression will be measured using the Hospital Anxiety and Depression Scale, a concise, self-administered 1 page form that categorizes anxiety and depression. The total score goes from 0-21, and scores are categorized from minimal to severe depression/anxiety. Higher total scores indicate greater levels of depression.

Time frame: 12 weeks after baseline testing

Population: Data from pre vs. post intervention were analyzed using a paired t-test only in subjects who completed all aspects of the trial and returned the questionnaires.

Fatigue will be measure using the Functional Assessment of Chronic Illness Therapy Fatigue, a 1 page form that uses a rating scale that goes from 0 to 52. It assesses the patient's fatigue levels in the last 7 days. It also measures how usual activities, performing work, walking, relationship, and enjoyment of life are affected by fatigue. A higher score indicates higher quality of life (and lower fatigue).

Time frame: 12 weeks after baseline testing

Population: Data from pre vs. post intervention were analyzed using a paired t-test only in subjects who completed all aspects of the trial and returned the questionnaires.

Quality of life will be measured using the Functional Assessment of Cancer Therapy-Prostate (FACT-P). The FACT-P is composed of both multi-item scales and single-item measures. These include physical, social, emotional, and functional well-being, along with an assessment of prostate-specific health status. five functional scales, three symptom scales, a global health status / QoL scale, and six single items. All of the individual questions are scored from 0-4 with total scores ranging between 0 and 156 where a higher number represents higher QoL.

Time frame: 12 weeks after baseline testing

Population: Data from pre vs. post intervention were analyzed using a paired t-test only in subjects who completed all aspects of the trial and returned the questionnaires.

To report changes in relative fat mass following the intervention. Total body percent fat (percentage of fat mass relative to total mass) will be measured using dual-energy x-ray absorptiometry (DXA) before and after the intervention.

Time frame: 12 weeks after baseline testing

Population: Data from pre vs. post intervention were analyzed using a paired t-test only in subjects who completed all aspects of the trial and the body composition scans.

The time to walk 400m (in sec) will be performed as an indicator of walking endurance and gait speed will be determined. A lower total time and higher gait speed indicates greater cardiorespiratory capacity and will be correlated with cardiopulmonary function scores (outcome 14).

Time frame: 12 weeks after baseline testing

Population: Data from pre vs. post intervention were analyzed using a paired t-test only in subjects who completed all aspects of the trial.

The time to complete (in sec) the 6m rapid walk test will be performed.

Time frame: 12 weeks after baseline testing

Population: Data from pre vs. post intervention were analyzed using a paired t-test only in subjects who completed all aspects of the trial.

The time to climb a flight of stairs (in sec) will be performed as an indicator of functional strength, muscle power, and balance. A lower total time (and higher calculated power output) is indicative of greater performance.

Time frame: 12 weeks after baseline testing

Population: Data from pre vs. post intervention were analyzed using a paired t-test only in subjects who completed all aspects of the trial.

The time to complete (in sec) the 2.44m (8 ft) timed up and go test will be performed as an indicator of agility, balance, and physical function. A lower total time is indicative of greater performance.

Time frame: 12 weeks after baseline testing

Population: Data from pre vs. post intervention were analyzed using a paired t-test only in subjects who completed all aspects of the trial.