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

Not Applicable

Completed

• Conditions: Prostate Cancer; Head and Neck Cancer; Rectum Cancer

• Registration Number: NCT03252821
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-31
• Study Start: 2017-08-15
• Study First Submitted QC: 2017-08-16
• Study First Posted: 2017-08-17
• Primary Completion: 2019-09-01
• Study Completion: 2019-09-20
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-16
• Last Update Posted: 2020-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cliniques universitaires Saint-Luc; 🇧🇪 Brussels, Belgium