Home-based Exercise Intervention for Patients With Metastatic Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
This single arm, multi-site pilot study aims to evaluate the feasibility of recruiting and adherence to a 12 week home-based exercise intervention to be conducted in men with metastatic castration resistant prostate cancer (mCRPC) receiving androgen deprivation therapy (ADT). Thirty patients will be enrolled, with the expectation that 20-25 will complete all follow-up measures.

Detailed Description
-----------------
The purpose of this trial is to evaluate the feasibility and adherence to a home-based 12 week exercise intervention in mCRPC patients receiving ADT. It will also examine if a home-based exercise intervention can improve muscle strength, body composition, physical function, cardiopulmonary function fatigue, and patient reported outcomes (fatigue, depression, quality of life (QoL)).

Official Title
-----------------
Feasibility Study of a Home-Based Exercise Intervention Program for Patients With Metastatic Castration-Resistant Prostate Cancer Receiving Androgen Deprivation Therapy (ADT)

Conditions
-----------------
Castration-resistant Prostate Cancer, Androgen Deprivation Therapy

Intervention / Treatment
-----------------
* Behavioral: Home-based exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Metastatic disease that has progressed despite castrate levels of testosterone (surgically or medically castrated, with testosterone levels of < 50 ng/dL) receiving ADT. This will be verified by assessing total testosterone levels within 4 weeks prior to enrollment. No current chemotherapy. Patients may be receiving additional hormonal therapy agents including but not limited to antiandrogens (e.g. bicalutamide, enzalutamide) and CYP17 inhibitors (e.g. abiraterone). Ability to engage safely in moderate exercise as determined by their treating physician. Not previously engaged in regular exercise training (<3 or more d/wk for > 30 min/d or <90 mins per week total including strength training, aerobic training, or walking) in the past 6 months. Access to a computer or a smart phone for syncing and uploading wearable activity data. Be able to speak and read English. Exclusion Criteria: Any condition that causes severe pain with exertion. History of bone fractures. Active cardiovascular disease including any of the following: New York Heart Association (NYHA) Grade II or greater congestive heart failure . History of myocardial infarction or unstable angina within 6 months prior to Day 1. History of stroke or transient ischemic attack within 6 months prior to Day 1. Acute or chronic respiratory disease that is severe enough to compromise the ability of the participant to safely engage in exercise training protocol. Acute or chronic bone/joint/muscular abnormalities compromising their ability to exercise. Neurological conditions that affect balance and, or muscle strength. Dementia, altered mental status or any psychiatric condition prohibiting the understanding or rendering of informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: Single-arm study with  30 men being recruited and 20-25 who complete all aspects of the study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home-based Exercise<br>The sole intervention group will complete a combination of aerobic and strength training  3 times per week for 12 weeks with each session lasting 1 hour. | Behavioral: Home-based exercise<br>* The intervention consists of aerobic and strength training  3 times per week for 12 weeks with each session lasting 1 hour. The progressive aerobic exercise will involve walking that varies from from 15 to 30 minutes done 2-4 times per week at an intensity from 40% to 65% of heart rate reserve. Therabands elastic bands will be used to perform 12 to 15 repetitions per exercise. Once a participant can comfortably complete 15 repetitions for all prescribed sets, they will increase resistance by moving up to the next band. The training volume increased from 1 set per exercise on week 1 to 3 sets by week 12.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients Who Complete the Pre/Post Exercise Intervention Testing. | 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. | 12 weeks after baseline testing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to the Intervention | 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. | 12 weeks after baseline testing | 
| Physical Function: 6m Walk | The time to complete (in sec) the 6m rapid walk test will be performed. | 12 weeks after baseline testing | 
| Physical Function: Timed Up and Go | 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. | 12 weeks after baseline testing | 
| Physical Function: Stair Climb | 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. | 12 weeks after baseline testing | 
| Physical Function: 400m Walk | 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). | 12 weeks after baseline testing | 
| Patient Reported Outcomes: Fatigue | 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). | 12 weeks after baseline testing | 
| Patient Reported Outcomes: Quality of Life | 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. | 12 weeks after baseline testing | 
| Patient Reported Outcomes: Depression | 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. | 12 weeks after baseline testing | 
| Patient Reported Outcomes: Anxiety | 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. | 12 weeks after baseline testing | 
| Muscle Size (Cross-sectional Area) | 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. | 12 weeks after baseline testing | 
| Muscle Quality | 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. | 12 weeks after baseline testing | 
| Chest Press Maximal Strength | 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. | 12 weeks after baseline testing | 
| Chest Press Muscle Endurance | 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. | 12 weeks after baseline testing | 
| Leg Press Maximal Strength | 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. | 12 weeks after baseline testing | 
| Leg Press Muscle Endurance | 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. | 12 weeks after baseline testing | 
| Cardiopulmonary Function | 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. | 12 weeks after baseline testing | 
| Lean Mass | 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. | 12 weeks after baseline testing | 
| Fat Mass | 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. | 12 weeks after baseline testing | 
| Percent Body Fat | 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. | 12 weeks after baseline testing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
exercise, hormone therapy