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

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ClinicalTrials.gov Identifier: NCT03252821
Recruitment Status : Recruiting
First Posted : August 17, 2017
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Caty Gilles, 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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Head and Neck Cancer Rectum Cancer Behavioral: High-intensity interval training Behavioral: Resistance training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of High-intensity Training Compared to Resistance Training in Cancer Patients Undergoing Radiotherapy
Actual Study Start Date : August 15, 2017
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).

No Intervention: Control group
Usual care



Primary Outcome Measures :
  1. Change in fatigue [ Time Frame: 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 :
  1. Change in functional capacity [ Time Frame: 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

  2. Change in quality of life [ Time Frame: 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

  3. Change in sleep disturbances [ Time Frame: 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

  4. Change in somnolence syndrome [ Time Frame: 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

  5. Change in insomnia [ Time Frame: 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

  6. Change in depression symptoms [ Time Frame: 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

  7. Change in executive functions [ Time Frame: 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

  8. Change in dyspnea [ Time Frame: 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

  9. Adherence [ Time Frame: Weekly through the intervention (during 8 weeks) ]
    Percentage of completed sessions



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03252821


Contacts
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Contact: Gilles Caty, PhD +322/764.16.50 gilles.caty@uclouvain.be
Contact: Elise Piraux, PhD student +322/764.53.75 elise.piraux@uclouvain.be

Locations
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Belgium
Cliniques universitaires Saint-Luc Recruiting
Brussels, Belgium, 1200
Contact: Gilles Caty         
Contact: Elise Piraux         
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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Responsible Party: Caty Gilles, Principal Investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT03252821     History of Changes
Other Study ID Numbers: 1
First Posted: August 17, 2017    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Head and Neck Neoplasms
Rectal Neoplasms
Neoplasms by Site
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases