Back to results

High-Intensity Training for Men With Prostate Cancer on Active Surveillance: A Feasibility Study

Primary Purpose

Prostate Cancer

Status

Terminated

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

High-intensity interval training (HIIT)

High-Intensity resistance training (HIRT)

About this trial

This is an interventional supportive care trial for Prostate Cancer focused on measuring Active Surveillance, Prostate Cancer, High-intensity interval training, Resistance training

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

18 years or older;
initiating or currently on AS for PCa;
not currently engaging in high-intensity aerobic and/or resistance training at 85%HRmax or ≥9 RPE in the Borg 0-10 RPE scale;
willing and able to travel to the study-designated facilities;
proficient in English;
able to provide written informed consent;
pass the screening CPET by achieving volitional exhaustion (rate of perceived exertion (RPE) ≥ 9 using the Borg 0-10 RPE scale) in the absence of any cardiorespiratory abnormalities.

Exclusion Criteria:

uncontrolled hypertension (≥2/3 of readings of > 160/90), regardless of whether on a regimen of anti-hypertensive therapy or not;
been diagnosed with congestive heart failure (New York Heart Association Class II, III or IV);
a history of serious cardiovascular events (within 12 months) including, but not limited to, transient ischemic attack (TIA), cerebrovascular accident (CVA), or myocardial infarction (MI);
a medical condition such as uncontrolled infection or cardiac disease that, in the opinion of the study physician, would make this protocol unreasonably hazardous for the patient;
a history of a psychiatric illness, which would prevent the patient from giving informed consent or adhering to the study protocol;
serious or non-healing wound, ulcer, or bone fracture;
experience shortness of breath, chest discomfort, or palpitations when performing activities of daily living;
ongoing restriction of physical activity;
developed chest pain in the past month

Sites / Locations

University of Toronto

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

High-Intensity interval training (HIIT)

High-intensity resistance training (HIRT)

Usual care (UC)

Arm Description

Provision of Cancer Care Ontario's physical activity guidelines for cancer survivors

Outcomes

Primary Outcome Measures

Recruitment rate (feasibility target: ≥25% of eligible patients)

Percent of consenting participants relative to the total number of eligible participants approached

Attendance rate (feasibility target: ≥70% to facility-based sessions)

Percent of completed facility-based sessions relative to the total number of prescribed facility-based sessions

Compliance rate (feasibility target: ≥70% of the prescribed exercises within supervised sessions)

Percent of completed repetitions relative to the total number of prescribed repetitions

Retention rate (feasibility target: 70% of participants consented to study)

Percent of participants that completed the study relative to the total number of participants consented to the study

Secondary Outcome Measures

Changes in cardiorespiratory fitness

Cardiopulmonary exercise test (CPET)-based assessment of peak oxygen uptake (VO2peak)

Changes in musculoskeletal strength

1 repetition maximum (1RM) will be assessed for upper (e.g., seated row and chest press) and lower body (e.g., leg press)

Changes in circulating cytokines

TNFalpha, interleukin (IL)-6, and IL-10 will be assessed using blood samples

Changes in circulating growth factors

Insulin-like growth factor-1 (IGF-1) and insulin-like binding protein 3 (IGFBP-3) will be assessed using blood samples

Body composition

Body mass will be measured using a weight scale (kg)

Changes in waist circumference

Waist circumference will be measured using a measuring tape (cm)

Changes in body fat and lean body mass

% body fat and % lean body mass will be measured using a bioelectrical impedance analysis (BIA) scale

Changes in Quality of Life

QoL will be measured using the Functional Assessment of Cancer Therapy-Prostate (FACT-P)

Anxiety

Anxiety will be measured using the Hospital Anxiety and Depression Scale (HADS) and the Memorial Anxiety Scale for Prostate Cancer (MAX-PC)

Fear of disease progression

Fear of disease progression will be measured using the Fear of Progression Questionnaire-Short Form (FOP-Q-SF)

Physical activity status

Changes in physical activity status will be measured using the Godin-Leisure Time Physical Activity Questionnaire (GLTEQ)

Full Information

NCT ID

NCT04266262

First Posted

February 6, 2020

Last Updated

November 2, 2020

Sponsor

University of Toronto

Collaborators

University Health Network, Toronto

1. Study Identification

Unique Protocol Identification Number

NCT04266262

Brief Title

High-Intensity Training for Men With Prostate Cancer on Active Surveillance: A Feasibility Study

Official Title

High-Intensity Training for Men With Prostate Cancer on Active Surveillance: A Feasibility Study

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Terminated

Why Stopped

All research activities were suspended as a result of COVID-19.

Study Start Date

July 9, 2018 (Actual)

Primary Completion Date

March 18, 2020 (Actual)

Study Completion Date

March 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Toronto

Collaborators

University Health Network, Toronto

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

This is a randomized study aiming to assess the feasibility of a phase II randomized controlled trial of different high-intensity training interventions and usual care (UC) in men with prostate cancer (PCa) undergoing active surveillance (AS).

Detailed Description

Primary objectives: The primary objective of this study is to assess the feasibility of conducting a three-armed randomized controlled trial comparing high-intensity interval training (HIIT), high-intensity resistance training (HIRT), and usual care (UC) in men with PCa on AS. The secondary exploratory objective of this study is to assess changes in cardiorespiratory fitness, musculoskeletal strength, body composition, circulating blood markers, and participant-self-reported outcomes (e.g., quality of life, anxiety, fear of disease progression) after 8 weeks of HIIT, HIRT, or UC. Methods: Participants will be randomized in a 1:1:1 ratio to HIIT, HIRT or UC group. Participants in the HIIT and HIRT group will undergo training 3 times per week (two supervised and one home-based/unsupervised training session) for 8 weeks. The UC group will be directed towards publicly available literature on physical activity (e.g., Cancer Care Ontario's physical activity guidelines for cancer survivors) and will receive an individualized exercise program upon completion of their final fitness assessment.

6. Conditions and Keywords

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

Prostate Cancer

Keywords

Active Surveillance, Prostate Cancer, High-intensity interval training, Resistance training

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High-Intensity interval training (HIIT)

Arm Type

Experimental

Arm Title

High-intensity resistance training (HIRT)

Arm Type

Experimental

Arm Title

Usual care (UC)

Arm Type

No Intervention

Arm Description

Provision of Cancer Care Ontario's physical activity guidelines for cancer survivors

Intervention Type

Behavioral

Intervention Name(s)

High-intensity interval training (HIIT)

Intervention Description

Supervised HIIT sessions (2x/week) will comprise cycling 10 x 60 secs at 85-95% maximum heart rate (HRmax) interspersed by 60 secs of low-intensity recovery. Unsupervised HIIT sessions (1x/week) will involve 10 x 60 secs of walking or alternative (intensity of 7-9 on the 0-10 RPE) interspersed by 60 secs of walking or cycling at low intensity recovery (RPE 3-5).

Intervention Type

Behavioral

Intervention Name(s)

High-Intensity resistance training (HIRT)

Intervention Description

Supervised HIRT sessions (2x/week) will comprise 2-3 sets of 6-8 repetitions progressively achieving 85% of 1RM. Unsupervised HIRT sessions (1x/week) will involve 2-3 sets of 15-20 repetitions using a resistance exercise band when necessary.

Primary Outcome Measure Information:

Title

Recruitment rate (feasibility target: ≥25% of eligible patients)

Description

Percent of consenting participants relative to the total number of eligible participants approached

Time Frame

Initiation through end of study recruitment at 26 months

Title

Attendance rate (feasibility target: ≥70% to facility-based sessions)

Description

Percent of completed facility-based sessions relative to the total number of prescribed facility-based sessions

Time Frame

Initiation through end of study intervention period at a maximum of 8 weeks post-randomization

Title

Compliance rate (feasibility target: ≥70% of the prescribed exercises within supervised sessions)

Description

Percent of completed repetitions relative to the total number of prescribed repetitions

Time Frame

Initiation through end of study intervention period at a maximum of 8 weeks post-randomization

Title

Retention rate (feasibility target: 70% of participants consented to study)

Description

Percent of participants that completed the study relative to the total number of participants consented to the study

Time Frame

Initiation through end of study intervention period at a maximum of 8 weeks post-randomization

Secondary Outcome Measure Information:

Title

Changes in cardiorespiratory fitness

Description

Cardiopulmonary exercise test (CPET)-based assessment of peak oxygen uptake (VO2peak)

Time Frame