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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-intensity aerobic training group | Experimental | High intensity interval training |
|
| Resistance training group | Active Comparator | Muscle strengthening |
|
| Control group | No Intervention | Usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-intensity interval training | Behavioral | High-intensity interval training sessions will be conducted on cycle ergometers or treadmill with heart rate measured throughout each session. |
| 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) |
| 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 |
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Inclusion criteria :
Exclusion criteria :
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques universitaires Saint-Luc | Brussels | 1200 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36299392 | Derived | 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. |
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| Resistance training | Behavioral | Resistance exercise will be performed on eight exercises targeting major muscle groups at 60% to 85% of their estimated one-repetition maximum (1RM). |
|
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) |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D000072696 | High-Intensity Interval Training |
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
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