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

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Prostate Cancer, Head and Neck Cancer, Rectum Cancer

Intervention / Treatment
-----------------
* Behavioral: High-intensity interval training
* Behavioral: Resistance training


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

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) |