Home-based Exercise Intervention for Patients With Metastatic Prostate Cancer

Not Applicable

Completed

Conditions: Castration-resistant Prostate Cancer
Androgen Deprivation Therapy

Interventions: Behavioral: Home-based exercise

Registration Number: NCT03672396

Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

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)).

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 22

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Home-based Exercise	Home-based exercise	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Patients Who Complete the Pre/Post Exercise Intervention Testing.	12 weeks after baseline 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.

Secondary Outcome Measures

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

Trial Locations

Locations (2): Comprehensive Cancer Center, Wake Forest Baptist Health
🇺🇸
Winston-Salem, North Carolina, United States
Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
🇺🇸
Chapel Hill, North Carolina, United States