Back to resultsHome-based Exercise Intervention for Patients With Metastatic Prostate Cancer
Primary Purpose
Castration-resistant Prostate Cancer, Androgen Deprivation Therapy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home-based exercise
Sponsored by
About this trial
This is an interventional health services research trial for Castration-resistant Prostate Cancer focused on measuring exercise, hormone therapy
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.
Sites / Locations
- Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
- Comprehensive Cancer Center, Wake Forest Baptist Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Home-based Exercise
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Physical Function: 6m Walk
The time to complete (in sec) the 6m rapid walk test will be performed.
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.
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.
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT03672396
First Posted
August 31, 2018
Last Updated
March 26, 2021
Sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03672396
Brief Title
Home-based Exercise Intervention for Patients With Metastatic Prostate Cancer
Official Title
Feasibility Study of a Home-Based Exercise Intervention Program for Patients With Metastatic Castration-Resistant Prostate Cancer Receiving Androgen Deprivation Therapy (ADT)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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)).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Castration-resistant Prostate Cancer, Androgen Deprivation Therapy
Keywords
exercise, hormone therapy
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single-arm study with ~30 men being recruited and 20-25 who complete all aspects of the study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Home-based Exercise
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Home-based exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Patients Who Complete the Pre/Post Exercise Intervention Testing.
Description
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
Secondary Outcome Measure Information:
Title
Adherence to the Intervention
Description
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
Title
Physical Function: 6m Walk
Description
The time to complete (in sec) the 6m rapid walk test will be performed.
Time Frame
12 weeks after baseline testing
Title
Physical Function: Timed Up and Go
Description
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
Title
Physical Function: Stair Climb
Description
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
Title
Physical Function: 400m Walk
Description
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
Title
Patient Reported Outcomes: Fatigue
Description
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
Title
Patient Reported Outcomes: Quality of Life
Description
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
Title
Patient Reported Outcomes: Depression
Description
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
Title
Patient Reported Outcomes: Anxiety
Description
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
Title
Muscle Size (Cross-sectional Area)
Description
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
Title
Muscle Quality
Description
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
Title
Chest Press Maximal Strength
Description
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
Title
Chest Press Muscle Endurance
Description
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
Title
Leg Press Maximal Strength
Description
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
Title
Leg Press Muscle Endurance
Description
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
Title
Cardiopulmonary Function
Description
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
Title
Lean Mass
Description
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
Title
Fat Mass
Description
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
Title
Percent Body Fat
Description
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik D Hanson, PhD
Organizational Affiliation
UNC-Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Comprehensive Cancer Center, Wake Forest Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Both sites (UNC and WF) are adding and storing data on a secure, centralized server. No individual data will be made available to protect the identity of the patients in the trial.
Learn more about this trial
Home-based Exercise Intervention for Patients With Metastatic Prostate Cancer
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