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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04266262
• Other study ID #: 16-6340
• Status: Terminated
• Phase: N/A
• Start date: July 9, 2018
• Est. completion date: March 20, 2020

Study information

• Verified date: November 2020
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: March 20, 2020
• Est. primary completion date: March 18, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• High-intensity interval training (HIIT)
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).
• High-Intensity resistance training (HIRT)
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.

Locations

Country	Name	City	State
Canada	University of Toronto	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Toronto	University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate (feasibility target: =25% of eligible patients)	Percent of consenting participants relative to the total number of eligible participants approached	Initiation through end of study recruitment at 26 months
Primary	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	Initiation through end of study intervention period at a maximum of 8 weeks post-randomization
Primary	Compliance rate (feasibility target: =70% of the prescribed exercises within supervised sessions)	Percent of completed repetitions relative to the total number of prescribed repetitions	Initiation through end of study intervention period at a maximum of 8 weeks post-randomization
Primary	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	Initiation through end of study intervention period at a maximum of 8 weeks post-randomization
Secondary	Changes in cardiorespiratory fitness	Cardiopulmonary exercise test (CPET)-based assessment of peak oxygen uptake (VO2peak)	At baseline and 8 weeks (post-intervention)
Secondary	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)	At baseline and 8 weeks (post-intervention)
Secondary	Changes in circulating cytokines	TNFalpha, interleukin (IL)-6, and IL-10 will be assessed using blood samples	At baseline and 8 weeks (post-intervention)
Secondary	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	At baseline and 8 weeks (post-intervention)
Secondary	Body composition	Body mass will be measured using a weight scale (kg)	At baseline and 8 weeks (post-intervention)
Secondary	Changes in waist circumference	Waist circumference will be measured using a measuring tape (cm)	At baseline and 8 weeks (post-intervention)
Secondary	Changes in body fat and lean body mass	% body fat and % lean body mass will be measured using a bioelectrical impedance analysis (BIA) scale	At baseline and 8 weeks (post-intervention)
Secondary	Changes in Quality of Life	QoL will be measured using the Functional Assessment of Cancer Therapy-Prostate (FACT-P)	At baseline and 8 weeks (post-intervention)
Secondary	Anxiety	Anxiety will be measured using the Hospital Anxiety and Depression Scale (HADS) and the Memorial Anxiety Scale for Prostate Cancer (MAX-PC)	At baseline and 8 weeks (post-intervention)
Secondary	Fear of disease progression	Fear of disease progression will be measured using the Fear of Progression Questionnaire-Short Form (FOP-Q-SF)	At baseline and 8 weeks (post-intervention)
Secondary	Physical activity status	Changes in physical activity status will be measured using the Godin-Leisure Time Physical Activity Questionnaire (GLTEQ)	At baseline and 8 weeks (post-intervention)