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

NCT04266262 | Terminated

• 1 other identifier: 16-6340
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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).

Conditions

Prostate Cancer

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (11)

• Changes in cardiorespiratory fitness

  At baseline and 8 weeks (post-intervention)

• Changes in musculoskeletal strength

  At baseline and 8 weeks (post-intervention)

• Changes in circulating cytokines

  At baseline and 8 weeks (post-intervention)

• Changes in circulating growth factors

  At baseline and 8 weeks (post-intervention)

• Body composition

  At baseline and 8 weeks (post-intervention)

Study Arms (3)

High-Intensity interval training (HIIT)

EXPERIMENTAL

Behavioral: High-intensity interval training (HIIT)

High-intensity resistance training (HIRT)

EXPERIMENTAL

Behavioral: High-Intensity resistance training (HIRT)

Usual care (UC)

NO INTERVENTION

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

Interventions

High-intensity interval training (HIIT) BEHAVIORAL

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 interval training (HIIT)

High-Intensity resistance training (HIRT) BEHAVIORAL

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.

High-intensity resistance training (HIRT)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Toronto: lead
• University Health Network, Toronto: collaborator

Study Sites (1)

University of Toronto

Toronto, Ontario, M5S 2W6, Canada

Location

Related Publications (1)

• Papadopoulos E, Gillen J, Moore D, Au D, Kurgan N, Klentrou P, Finelli A, Alibhai SMH, Santa Mina D. High-intensity interval training or resistance training versus usual care in men with prostate cancer on active surveillance: a 3-arm feasibility randomized controlled trial. Appl Physiol Nutr Metab. 2021 Dec;46(12):1535-1544. doi: 10.1139/apnm-2021-0365. Epub 2021 Aug 11.

  PMID: 34380000 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: February 12, 2020
• Study Start: July 9, 2018
• Primary Completion: March 18, 2020
• Study Completion: March 20, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)