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A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer

Primary Purpose

Exercise, Prostate Cancer

Status

Recruiting

Phase

Phase 1

Locations

Ireland

Study Type

Interventional

Intervention

Exercise

About this trial

This is an interventional health services research trial for Exercise focused on measuring Prostate Cancer, Physical Fitness, Androgen Deprivation Therapy, Exercise, Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

>18 years of age with a histologically diagnosed prostate cancer
Prescribed ADT (Androgen deprivation Therapy)
Self-reported not to be partaking in regular exercise (structured aerobic or resistance training ≥ 2 sessions/week) in the past 3 months.
Medically cleared to exercise by their oncologist

Exclusion Criteria:

Prior exposure to ADT >12 months
Prior hypogonadism
Established metastatic bone disease
Established Osteoporosis
Musculoskeletal/Cardiovascular and/or Neurological disease that could put them at risk from exercise as judged by the attending physician.

Sites / Locations

WIT Sports ArenaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Aerobic Emphasised Exercise Intervention

Resistance Emphasised Exercise Intervention

Arm Description

The intervention will comprise of 24 weeks of twice weekly supervised exercise sessions, emphasising aerobic exercise. To reflect a real-world setting, each group will experience both aerobic and resistance exercise, but there will be a 75%:25% predominant: subsidiary mode emphasis based on exercise duration within each session.

The intervention will comprise of 24 weeks of twice weekly supervised exercise sessions, emphasising resistance exercise. To reflect a real-world setting, each group will experience both aerobic and resistance exercise, but there will be a 75%:25% predominant: subsidiary mode emphasis based on exercise duration of exercise within each session.

Outcomes

Primary Outcome Measures

Feasibility- recruitment rate (%)

The recruitment rate will be established by comparing the number of potential participants approached and how many agreed to participate in the trial. This will be reported in percentage format.

Feasibility- retention rate (%)

Percentage of participants that completed the 24 week intervention compared to the number of participants randomised. This will be reported in percentage format.

Feasibility- exercise program adherence through attendance %.

The research team will report adherence to the exercise program through attendance of supervised classes. Attendance will be reported as a percentage.

Feasibility- exercise prescription adherence (% of modified sessions compared to attended exercise sessions)

The research team will report adherence to the exercise prescription by reporting the number of modified sessions compared to attended exercise sessions. This will be reported as a percentage.

Feasibility- Adverse Event using CTCAE v4.0 grading system.

The research team will report any adverse events in general or in relation to the exercise program using CTCAE v4.0 grading system.

Feasibility- Patient satisfaction/acceptability through qualitative evaluation.

Determined by qualitative evaluation, using semi structured interviews and exit surveys to evaluate the acceptability, experiences and feasibility of the intervention.

Secondary Outcome Measures

General quality of life by questionnaire

The RAND 36-Item Health Survey comprises of 36 questions and assesses eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Scores range from 0-100. A higher score indicates a high quality of life and a favourable health status.

Cancer Specific quality of life by questionnaire

The European Organisation for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) comprises of 30 questions, categorised into five functioning scales (physical, role, cognitive, emotional and social), three symptom scales (fatigue, pain and nausea/vomiting) and one global health status scale. The remaining six single-item (dyspnoea, appetite loss, sleep disturbance, constipation, diarrhoea and the financial impact) scales assess symptoms. Scores range from 0-100. A higher score for the functional scales and global health status indicates better functioning and quality of life. A higher score on the symptom and single-item scales denotes a high level of symptoms (i.e. a poor quality of life).

Prostate cancer specific quality of life by questionnaire

The European Organisation for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-PR25) is a prostate cancer supplementary questionnaire module to be employed in conjunction with EORTC QLQ-C30. It comprises of five multi-item scales to assess sexual activity, sexual functioning, urinary symptoms, bowel symptoms and hormonal treatment-related symptoms and one single item assessing incontinence. Scores range from 0-100. A high score for the sexual activity and sexual functioning scales represents a high level of functioning. A high score for urinary, bowel and hormonal treatment related symptoms scales and incontinence aid item represents a high level of symptomatology.

Fatigue by questionnaire

The Functional Assessment of Cancer Therapy - Fatigue (FACIT-Fatigue) questionnaire will be used to measure fatigue. Patients will score 13 fatigue items over the past 7 days on a scale (0 = not at all; 4 = very much), generating a total (0 - 52). A higher score indicates lower levels of fatigue.

Physical Activity (subjective) by questionnaire

The Godin Leisure Time Exercise questionnaire will be used to calculate the average amount of strenuous, moderate and light exercise a participant performs in a typical 7 day period. A score of 24 units or more indicates the participant is active, 14-23 units indicates moderately active and less than 14 units suggests the participant is insufficiently active/sedentary.

Anthropometric assessment.

Height will be measured in cm and body weight in kg, which will be combined to report BMI in kg/m(squared).

Waist and Hip circumference analysis (cms)

Waist circumference and hip circumference will be measured in centimetres. These two measurements will be used to calculate the participants waist: hip ratio. All measurements will be taken in duplication and averaged before data entry. If there is a substantial difference between the two measures, a third measurement will be taken.

Body composition (fat mass) analysis using Dual Energy X Ray Absorptiometry (Dexa)

Fat mass (grams and percentage) will be assessed using DEXA (Horizon W, Hologic, 304492M). Participants will be scanned after an overnight fast and will be instructed to regulate their water/fluid intake in the days leading up to the scan, so they are adequately hydrated. All scans will be completed at the same time as much as possible to account for physiological changes in body composition throughout the day.

Body composition (fat and lean mass) analysis using Dual Energy X Ray Absorptiometry (Dexa)

Lean mass (grams and percentage) will be assessed using DEXA (Horizon W, Hologic, 304492M). Participants will be scanned after an overnight fast and will be instructed to regulate their water/fluid intake in the days leading up to the scan, so they are adequately hydrated. All scans will be completed at the same time as much as possible to account for physiological changes in body composition throughout the day.

Bone density (BMD) measurement

Whole body bone Density will be measured using DEXA (Horizon W, Hologic, 304492M). BMD will be measured in g/cm(squared) and used to calculate a T-score (SD). A T-score shows how much a participant's BMD is higher or lower than the BMD of a healthy 30 year old adult and is the score most commonly used to diagnose low BMD.

Visceral fat area (VAT Area) in cm(squared)

Visceral fat area will be assessed using DEXA (Horizon W, Hologic, 304492M). It will be measured in cm(squared). Participants will be scanned after an overnight fast and will be instructed to regulate their water/fluid intake in the days leading up to the scan, so they are adequately hydrated. All scans will be completed at the same time as much as possible to account for physiological changes in body composition throughout the day

Atrial stiffness measured by a Pulse Wave Velocity Assessment (m/s)

A carotid-femoral pulse wave velocity test will be performed to assess arterial stiffness. It will be measured in meters per seconds (m/s). This will be performed as per manufactural instructions using a Complior, Alam medical device. Measurements will be taken in duplicate and the mean recorded, with a third measurement taken if difference between the two measurements is more than 0.5 m/s and median recorded.

Blood pressure (mmHg)

Blood pressure (diastolic and systolic) measured at rest. Blood pressure will be taken according to the American Heart Association's (AHA) guidelines. At least two readings and the average recorded. Additional readings will be taken if the difference between the two reading exceeds 5mm Hg.

Cardiovascular Fitness

Cardiovascular fitness will be determined by a submaximal incremental treadmill test using a modified Bruce protocol. The test will be scored by the time (minutes and seconds) taken to test completion. A longer time to completion means superior cardiovascular fitness.

Peak torque/power for knee extension and flexion

An isokinetic dynamometry for knee extension and flexion will also be performed on a Biodex (Advantage BX™ Software Update v5.3.00) to measure peak torque (n.M) and power, using a similar protocol as previously used in cancer patients.

Lower limb strength [Leg Press]

Leg press 1 repetition maximum will be measured in kilograms (kg). A 1 repetition maximum is defined as the highest load that can be lifted through full range of movement for one time.

Upper limb strength [Chest Press]

Chest press 1 repetition maximum will be measured in kilograms (kg). A 1 repetition maximum is defined as the highest load that can be lifted through full range of movement for one time.

Functional Ability Assessment (Timed up and go)

The timed up and go assess the time (in seconds) it takes for a person to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees. It assesses mobility, balance, walking ability and falls risk in older adults. A lower score indicates better physical function.

Functional Ability Assessment (Sit to stand)

Sit to stand assesses the maximal repetitions a participant can stand up from a chair in 30 seconds. A higher score indicates better physical function.

Functional Ability Assessment (Grip test)

A hand-held dynamometry will be used to measure grip strength for each arm. this is a measure of upper body strength and a higher score suggests better upper body strength

Functional Ability Assessment (Bess Balance test)

The Balance Error Scoring System is an objective measure of assessing static postural stability. A lower score= better balance and reduced falls risk.

Functional Ability Assessment (6 minute walk test)

A 6-min walk test measured the maximal meters walked in six minutes. A higher score indicated superior aerobic endurance and capacity.

Functional Ability Assessment (Sit and reach)

The sit and reach test measures linear flexibility. The score is the most distant point (cm) reached with the fingertips. A higher score indicates better flexibility

Biomarker Analysis: Blood lipids (mmol/L)

Blood lipids (total cholesterol, triglycerides, LDH and HDL) will be analysed Fasting blood will be taken from all participants using a standard venipuncture technique. All bloods will be analyzed in a certified clinical lab.

Biomarker Analysis: Glucose (mmol/L)

Fasted blood will be used to measure blood glucose (mmol/L),

Biomarker Analysis: Insulin (mIU/L)

Fasted blood will be used to measure blood insulin (mIU/L)

Biomarker Analysis: C-Reactive Protein (CRP)

Fasted blood will be used to measure C-reactive protein (mg/dL).

Full Information

NCT ID

NCT05156424

First Posted

October 31, 2021

Last Updated

December 13, 2021

Sponsor

Kira Murphy

Collaborators

Irish Research Council, University of Pittsburgh Medical Center, Waterford Instituate of Technology

1. Study Identification

Unique Protocol Identification Number

NCT05156424

Brief Title

A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer

Official Title

A Comparison of Aerobic and Resistance Exercise for Counteracting the Adverse Effects of Androgen Deprivation Therapy in Men With Prostate Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Recruiting

Study Start Date

September 9, 2021 (Actual)

Primary Completion Date

March 1, 2023 (Anticipated)

Study Completion Date

March 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Kira Murphy

Collaborators

Irish Research Council, University of Pittsburgh Medical Center, Waterford Instituate of Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Prostate cancer is the second most common cancer in men. Those in the intermediate/high-risk categories typically receive androgen deprivation therapy (ADT) and radiotherapy. ADT greatly reduces androgen production as prostate cancer is dependent on testosterone and dihydrotestosterone for its growth.The side effects of ADT therapy are extensive and include changes in body composition (muscle loss, bone loss and fat gain), strength, mood, physical function, sexual function and increased cardiovascular risk and fatigue. Many of these side effects can be influenced by exercise training, both resistance training and aerobic training. However, the most appropriate exercise regime for men undergoing ADT has received little research attention.

Detailed Description

Although many interventions for prostate survivors emphasise resistance exercise to maintain muscle mass and strength. Arguments could equally be made for programmes emphasising aerobic exercise for fatigue, anxiety, cardiovascular risk reduction and indeed overall survival. Comparisons of programmes that emphasise each exercise mode are clearly required. Therefore the overall purpose of this feasibility and pilot randomised control trial is to determine the feasibility and preliminary effectiveness of an aerobic emphasised exercise program (AE) verses a resistance emphasise exercise program (RE) in a rehabilitation setting, over 6 months, for prostate cancer men undergoing Androgen Deprivation Therapy (ADT).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Exercise, Prostate Cancer

Keywords

Prostate Cancer, Physical Fitness, Androgen Deprivation Therapy, Exercise, Cancer

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Pilot randomised control trial

Masking

None (Open Label)

Allocation

Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Aerobic Emphasised Exercise Intervention

Arm Type

Experimental

Arm Description

Arm Title

Resistance Emphasised Exercise Intervention

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Exercise

Intervention Description

An individualised, progressive and autoregulated exercise programme, supervised by a trained professional.

Primary Outcome Measure Information:

Title

Feasibility- recruitment rate (%)

Description

The recruitment rate will be established by comparing the number of potential participants approached and how many agreed to participate in the trial. This will be reported in percentage format.

Time Frame

At study conclusion

Title

Feasibility- retention rate (%)

Description

Percentage of participants that completed the 24 week intervention compared to the number of participants randomised. This will be reported in percentage format.

Time Frame

Intervention conclusion 24 weeks

Title

Feasibility- exercise program adherence through attendance %.

Description

The research team will report adherence to the exercise program through attendance of supervised classes. Attendance will be reported as a percentage.

Time Frame

Throughout 24 week intervention

Title

Feasibility- exercise prescription adherence (% of modified sessions compared to attended exercise sessions)

Description

The research team will report adherence to the exercise prescription by reporting the number of modified sessions compared to attended exercise sessions. This will be reported as a percentage.

Time Frame

Throughout 24 week intervention

Title

Feasibility- Adverse Event using CTCAE v4.0 grading system.

Description

The research team will report any adverse events in general or in relation to the exercise program using CTCAE v4.0 grading system.

Time Frame

At study conclusion

Title

Feasibility- Patient satisfaction/acceptability through qualitative evaluation.

Description

Determined by qualitative evaluation, using semi structured interviews and exit surveys to evaluate the acceptability, experiences and feasibility of the intervention.

Time Frame

Following intervention conclusion at 24 weeks

Secondary Outcome Measure Information:

Title

General quality of life by questionnaire

Description

Time Frame

At baseline, 8 weeks and 24 weeks (end of intervention)

Title

Cancer Specific quality of life by questionnaire

Description

Time Frame

At baseline, 8 weeks and 24 weeks (end of intervention)

Title

Prostate cancer specific quality of life by questionnaire

Description

Time Frame

At baseline, 8 weeks and 24 weeks (end of intervention)

Title

Fatigue by questionnaire

Description

Time Frame

At baseline, 8 weeks and 24 weeks (end of intervention)

Title

Physical Activity (subjective) by questionnaire

Description

Time Frame

At baseline, 8 weeks and 24 weeks (end of intervention)

Title

Anthropometric assessment.

Description

Height will be measured in cm and body weight in kg, which will be combined to report BMI in kg/m(squared).

Time Frame

At baseline and 24 weeks (end of intervention)

Title

Waist and Hip circumference analysis (cms)

Description

Time Frame

At baseline and 24 weeks (end of intervention)

Title

Body composition (fat mass) analysis using Dual Energy X Ray Absorptiometry (Dexa)

Description

Time Frame

At baseline and 24 weeks (end of intervention)

Title

Body composition (fat and lean mass) analysis using Dual Energy X Ray Absorptiometry (Dexa)

Description

Time Frame

At baseline and 24 weeks (end of intervention)

Title

Bone density (BMD) measurement

Description

Time Frame

At baseline and 24 weeks (end of intervention)

Title

Visceral fat area (VAT Area) in cm(squared)

Description

Time Frame

At baseline and 24 weeks (end of intervention)

Title

Atrial stiffness measured by a Pulse Wave Velocity Assessment (m/s)

Description

Time Frame

At baseline and 24 weeks (end of intervention)

Title

Blood pressure (mmHg)

Description

Time Frame

At baseline and 24 weeks (end of intervention)

Title

Cardiovascular Fitness

Description

Time Frame

0(baseline), 8 weeks and 6 months (end of intervention)

Title

Peak torque/power for knee extension and flexion

Description

Time Frame

At baseline and 24 weeks (end of intervention)

Title

Lower limb strength [Leg Press]

Description

Leg press 1 repetition maximum will be measured in kilograms (kg). A 1 repetition maximum is defined as the highest load that can be lifted through full range of movement for one time.

Time Frame

At baseline and 24 weeks (end of intervention)

Title

Upper limb strength [Chest Press]

Description

Chest press 1 repetition maximum will be measured in kilograms (kg). A 1 repetition maximum is defined as the highest load that can be lifted through full range of movement for one time.

Time Frame

At baseline and 24 weeks (end of intervention)

Title

Functional Ability Assessment (Timed up and go)

Description

Time Frame

At baseline, 8 weeks and 24 weeks (end of intervention)

Title

Functional Ability Assessment (Sit to stand)

Description

Sit to stand assesses the maximal repetitions a participant can stand up from a chair in 30 seconds. A higher score indicates better physical function.

Time Frame

At baseline, 8 weeks and 24 weeks (end of intervention)

Title

Functional Ability Assessment (Grip test)

Description

A hand-held dynamometry will be used to measure grip strength for each arm. this is a measure of upper body strength and a higher score suggests better upper body strength

Time Frame

At baseline, 8 weeks and 24 weeks (end of intervention)

Title

Functional Ability Assessment (Bess Balance test)

Description

The Balance Error Scoring System is an objective measure of assessing static postural stability. A lower score= better balance and reduced falls risk.

Time Frame

At baseline, 8 weeks and 24 weeks (end of intervention)

Title

Functional Ability Assessment (6 minute walk test)

Description

A 6-min walk test measured the maximal meters walked in six minutes. A higher score indicated superior aerobic endurance and capacity.

Time Frame

At baseline, 8 weeks and 24 weeks (end of intervention)

Title

Functional Ability Assessment (Sit and reach)

Description

The sit and reach test measures linear flexibility. The score is the most distant point (cm) reached with the fingertips. A higher score indicates better flexibility

Time Frame

At baseline, 8 weeks and 24 weeks (end of intervention)

Title

Biomarker Analysis: Blood lipids (mmol/L)

Description

Time Frame

At baseline and 24 weeks (end of intervention)

Title

Biomarker Analysis: Glucose (mmol/L)

Description

Fasted blood will be used to measure blood glucose (mmol/L),

Time Frame

At baseline and 24 weeks (end of intervention)

Title

Biomarker Analysis: Insulin (mIU/L)

Description

Fasted blood will be used to measure blood insulin (mIU/L)

Time Frame

At baseline and 24 weeks (end of intervention)

Title

Biomarker Analysis: C-Reactive Protein (CRP)

Description

Fasted blood will be used to measure C-reactive protein (mg/dL).

Time Frame

At baseline and 24 weeks (end of intervention)

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

Men diagnosed with prostate cancer will be recruited.

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: >18 years of age with a histologically diagnosed prostate cancer Prescribed ADT (Androgen deprivation Therapy) Self-reported not to be partaking in regular exercise (structured aerobic or resistance training ≥ 2 sessions/week) in the past 3 months. Medically cleared to exercise by their oncologist Exclusion Criteria: Prior exposure to ADT >12 months Prior hypogonadism Established metastatic bone disease Established Osteoporosis Musculoskeletal/Cardiovascular and/or Neurological disease that could put them at risk from exercise as judged by the attending physician.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Michael Dr Harrison, PhD

Phone

51302161

Ext

+353

mharrison@wit.ie

First Name & Middle Initial & Last Name or Official Title & Degree

Kira Ms Murphy, BSc (Hons)

murphyk@upmc.ie

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Dr Harrison, PhD

Organizational Affiliation

Waterford Institute of Technology

Official's Role

Principal Investigator

Facility Information:

Facility Name

WIT Sports Arena

City

Waterford

State/Province

Munster

Country

Ireland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kira Ms Murphy, BSc

Phone

+353 51 376827

murphyk@upmc.ie

First Name & Middle Initial & Last Name & Degree

Michael Dr Harrison, PhD

Phone

+353 51 302161

mharrison@wit.ie

First Name & Middle Initial & Last Name & Degree

Michael Dr Harrison, PhD

First Name & Middle Initial & Last Name & Degree

Bróna Dr Keheo, PhD

First Name & Middle Initial & Last Name & Degree

Suzanne Dr Denieffe, PhD

First Name & Middle Initial & Last Name & Degree

Hacking Dr Dayle, M.B.Ch, M.Med. Rat,

12. IPD Sharing Statement

Plan to Share IPD

Citations:

Citation

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Citation

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Results Reference

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PubMed Identifier

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Citation

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Citation

Norris MK, Bell GJ, North S, Courneya KS. Effects of resistance training frequency on physical functioning and quality of life in prostate cancer survivors: a pilot randomized controlled trial. Prostate Cancer Prostatic Dis. 2015 Sep;18(3):281-7. doi: 10.1038/pcan.2015.28. Epub 2015 Jun 16.

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A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer

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