- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03672396
Home-based Exercise Intervention for Patients With Metastatic Prostate Cancer
Feasibility Study of a Home-Based Exercise Intervention Program for Patients With Metastatic Castration-Resistant Prostate Cancer Receiving Androgen Deprivation Therapy (ADT)
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
-
Winston-Salem, North Carolina, United States, 27103
- Comprehensive Cancer Center, Wake Forest Baptist Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
|
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.
Time Frame: 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. |
12 weeks after baseline testing
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence to the Intervention
Time Frame: 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. |
12 weeks after baseline testing
|
Physical Function: 6m Walk
Time Frame: 12 weeks after baseline testing
|
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
Time Frame: 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.
|
12 weeks after baseline testing
|
Physical Function: Stair Climb
Time Frame: 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.
|
12 weeks after baseline testing
|
Physical Function: 400m Walk
Time Frame: 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).
|
12 weeks after baseline testing
|
Patient Reported Outcomes: Fatigue
Time Frame: 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).
|
12 weeks after baseline testing
|
Patient Reported Outcomes: Quality of Life
Time Frame: 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.
|
12 weeks after baseline testing
|
Patient Reported Outcomes: Depression
Time Frame: 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.
|
12 weeks after baseline testing
|
Patient Reported Outcomes: Anxiety
Time Frame: 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.
|
12 weeks after baseline testing
|
Muscle Size (Cross-sectional Area)
Time Frame: 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.
|
12 weeks after baseline testing
|
Muscle Quality
Time Frame: 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.
|
12 weeks after baseline testing
|
Chest Press Maximal Strength
Time Frame: 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.
|
12 weeks after baseline testing
|
Chest Press Muscle Endurance
Time Frame: 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.
|
12 weeks after baseline testing
|
Leg Press Maximal Strength
Time Frame: 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.
|
12 weeks after baseline testing
|
Leg Press Muscle Endurance
Time Frame: 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.
|
12 weeks after baseline testing
|
Cardiopulmonary Function
Time Frame: 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.
|
12 weeks after baseline testing
|
Lean Mass
Time Frame: 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.
|
12 weeks after baseline testing
|
Fat Mass
Time Frame: 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.
|
12 weeks after baseline testing
|
Percent Body Fat
Time Frame: 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.
|
12 weeks after baseline testing
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LCCC1613
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Castration-resistant Prostate Cancer
-
Nuvation Bio Inc.WithdrawnProstate Cancer | Prostate Neoplasm | Cancer of the Prostate | Prostatic Cancer | Castrate Resistant Prostate Cancer | Cancer of Prostate | Castration Resistant Prostatic Cancer | Castration Resistant Prostatic NeoplasmsUnited States
-
Janux TherapeuticsRecruitingProstate Cancer | Metastatic Castration-resistant Prostate Cancer | Castration Resistant Prostatic CancerUnited States, Australia
-
Universität des SaarlandesRecruitingProstate Cancer Metastatic | Advanced Prostate Carcinoma | Castration Resistant Prostatic CancerGermany
-
Myovant Sciences GmbHRecruitingMetastatic Castration-Resistant Prostate Cancer | Metastatic Castration-Sensitive Prostate Cancer | Non-Metastatic Castration-Resistant Prostate CancerUnited States
-
Astellas Pharma IncPfizerCompletedCastration-resistant Prostate CancerJapan
-
University Hospital, GrenobleTerminatedCastration-resistant Prostate CancerFrance
-
Massachusetts General HospitalBayerCompletedProstate Cancer | Castration-resistant Prostate Cancer | Castration-resistant Prostate Cancer Metastatic to BoneUnited States
-
Sidney Kimmel Comprehensive Cancer Center at Johns...Clarus TherapeuticsRecruitingProstate Cancer | Castration-resistant Prostate Cancer | Metastatic Castration-resistant Prostate CancerUnited States
-
BAMF HealthRecruitingMetastatic Castration-resistant Prostate CancerUnited States
-
Translational Research Center for Medical Innovation...CompletedCastration Resistant Prostate Cancer (CRPC)
Clinical Trials on Home-based exercise
-
University of OklahomaNational Institute on Aging (NIA); Milton S. Hershey Medical Center; Case Western...Not yet recruitingPeripheral Artery Disease | ClaudicationUnited States
-
University GhentTerminatedHypermobile Ehlers-Danlos Syndrome | Hypermobility Syndrome | Multidirectional Subluxation of ShoulderBelgium
-
University of WaterlooAlzheimer's AssociationCompletedDementia | Mild Cognitive ImpairmentCanada
-
Uskudar UniversityRecruitingAdolescent Idiopathic ScoliosisTurkey
-
Hacettepe UniversityCompletedKnee OsteoarthritisTurkey
-
University of FlorenceUnknownCardiovascular DiseaseItaly
-
Karolinska InstitutetMayo ClinicNot yet recruitingCOPD, Chronic Obstructive Pulmonary DiseaseSweden
-
University of Sao PauloCompletedObesity | Bariatric SurgeryBrazil
-
Istanbul UniversityCompleted
-
Cardenal Herrera UniversityConsorci Sanitari de Terrassa. Hospital de TerrassaCompletedChronic Kidney Disease | End-stage Renal DiseaseSpain