Effects of High-intensity Training Compared to Resistance Training in Cancer Patients Undergoing Radiotherapy

The aim of this study is to assess the impact of a high-intensity aerobic training and resistance training on fatigue in prostate, head and neck and rectum cancer patients undergoing radiotherapy.

A three-arm randomized controlled trial will be conducted. Patients will be randomised into either a high-intensity aerobic training group or a resistance training group or a control group. Participants in the training groups will exercised for five to eight weeks. Exercise sessions will be take place 3 days per week under the supervision of an experienced therapist. Subjects will be assessed at baseline and post-intervention. The primary outcome will be fatigue measured using the FACIT-fatigue questionnaire. The secondary outcomes will be: functional capacity, quality of life, executive functions, sleep disturbances, somnolence syndrome, insomnia, depression symptoms.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer; Prostate Cancer; Rectum Cancer
• Intervention / Treatment: Behavioral: High-intensity interval training; Behavioral: Resistance training

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Cliniques Universitaires Saint-luc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria :

• a primary diagnosis of prostate cancer, head and neck cancer (oral cavity, pharynx, larynx, nasal cavity/sinuses, or salivary gland) or rectum cancer;
• age over 18 years;
• no distant metastases and/or disease progression;
• at least 25 scheduled radiation treatments (5 weeks);
• ability to read, write, and speak French.

Exclusion criteria :

• uncontrolled cardiac, hypertensive or pulmonary diseases,
• uncontrolled insulin-dependent diabetes mellitus,
• neuropsychiatric disorders or orthopaedic conditions that would impair exercise participation
• abnormal electrocardiogram.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Usual care
Experimental: High-intensity aerobic training group; High intensity interval training	Behavioral: High-intensity interval training; High-intensity interval training sessions will be conducted on cycle ergometers or treadmill with heart rate measured throughout each session.
Active Comparator: Resistance training group; Muscle strengthening	Behavioral: Resistance training; Resistance exercise will be performed on eight exercises targeting major muscle groups at 60% to 85% of their estimated one-repetition maximum (1RM).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in fatigue	Fatigue is measured by FACIT-fatigue questionnaire	Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in functional capacity	Functional capacity is measured by 6-minute walk test	Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)
Change in quality of life	Quality of life is measured by Functional Assessment of Cancer Therapy-General	Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)
Change in sleep disturbances	Sleep disturbances are measured by Pittsburgh Sleep Quality Index	Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)
Change in somnolence syndrome	Somnolence syndrome is measured by Epworth Sleepiness Scale	Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)
Change in insomnia	Insomnia is measured by Insomnia Severity Index	Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)
Change in depression symptoms	Depression symptoms are measured by Center for Epidemiologic Studies Depression Scale	Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)
Change in executive functions	Executive functions is measured by the Trail Making Test	Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)
Change in dyspnea	Dyspnea is measured by Multidimensional Dyspnea Profile	Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)
Adherence	Percentage of completed sessions	Weekly through the intervention (during 8 weeks)

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Publications and helpful links

General Publications

• Piraux E, Reychler G, Vancraeynest D, Geets X, Leonard D, Caty G. High-intensity aerobic interval training and resistance training are feasible in rectal cancer patients undergoing chemoradiotherapy: a feasibility randomized controlled study. Rep Pract Oncol Radiother. 2022 May 19;27(2):198-208. doi: 10.5603/RPOR.a2022.0036. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2017
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): September 20, 2019

Study Registration Dates

• First Submitted: July 31, 2017
• First Submitted That Met QC Criteria: August 16, 2017
• First Posted (Actual): August 17, 2017

Study Record Updates

• Last Update Posted (Actual): March 17, 2020
• Last Update Submitted That Met QC Criteria: March 16, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: 1 (Other Identifier: Mobile Health and Wellness Program)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No