An interventional study of High-intensity interval training and Resistance training in Prostate Cancer, Head and Neck Cancer and Rectum Cancer, sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-17.
Sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Not applicable, Interventional, and Treatment
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.
6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.
This study's enrollment of 78 is above the median of 58 across 4,908 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Cliniques universitaires Saint-Luc- Université Catholique de Louvain is the lead sponsor of 348 studies on the registry; 62 are open to participants now.
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Exclusion criteria :
High intensity interval training
Behavioral: High-intensity interval training
Muscle strengthening
Behavioral: Resistance training
Usual care
High-intensity interval training sessions will be conducted on cycle ergometers or treadmill with heart rate measured throughout each session.
Resistance exercise will be performed on eight exercises targeting major muscle groups at 60% to 85% of their estimated one-repetition maximum (1RM).
Change in fatigue
Fatigue is measured by FACIT-fatigue questionnaire
Time frame: Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)
Change in functional capacity
Functional capacity is measured by 6-minute walk test
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Weekly through the intervention (during 8 weeks)
Plan to share: Undecided
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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