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

Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain (Other)
Overall Status
Completed
CT.gov ID
NCT03252821
Collaborator
(none)
78
1
3
25.2
3.1

Study Details

Study Description

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
  • Behavioral: High-intensity interval training
  • Behavioral: Resistance training
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
78 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 :
Aug 15, 2017
Actual Primary Completion Date :
Sep 1, 2019
Actual Study Completion Date :
Sep 20, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. Adherence [Weekly through the intervention (during 8 weeks)]

    Percentage of completed sessions

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cliniques universitaires Saint-Luc Brussels Belgium 1200

Sponsors and Collaborators

  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Caty Gilles, Principal Investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT03252821
Other Study ID Numbers:
  • 1
First Posted:
Aug 17, 2017
Last Update Posted:
Mar 17, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 17, 2020