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

Primary Purpose

Prostate Cancer, Head and Neck Cancer, Rectum Cancer

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
High-intensity interval training
Resistance training
Sponsored by
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cliniques universitaires Saint-Luc

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

High-intensity aerobic training group

Resistance training group

Control group

Arm Description

High intensity interval training

Muscle strengthening

Usual care

Outcomes

Primary Outcome Measures

Change in fatigue
Fatigue is measured by FACIT-fatigue questionnaire

Secondary Outcome Measures

Change in functional capacity
Functional capacity is measured by 6-minute walk test
Change in quality of life
Quality of life is measured by Functional Assessment of Cancer Therapy-General
Change in sleep disturbances
Sleep disturbances are measured by Pittsburgh Sleep Quality Index
Change in somnolence syndrome
Somnolence syndrome is measured by Epworth Sleepiness Scale
Change in insomnia
Insomnia is measured by Insomnia Severity Index
Change in depression symptoms
Depression symptoms are measured by Center for Epidemiologic Studies Depression Scale
Change in executive functions
Executive functions is measured by the Trail Making Test
Change in dyspnea
Dyspnea is measured by Multidimensional Dyspnea Profile
Adherence
Percentage of completed sessions

Full Information

First Posted
July 31, 2017
Last Updated
March 16, 2020
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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1. Study Identification

Unique Protocol Identification Number
NCT03252821
Brief Title
Effects of High-intensity Training Compared to Resistance Training in Cancer Patients Undergoing Radiotherapy
Official Title
Effects of High-intensity Training Compared to Resistance Training in Cancer Patients Undergoing Radiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
August 15, 2017 (Actual)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
September 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Head and Neck Cancer, Rectum Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-intensity aerobic training group
Arm Type
Experimental
Arm Description
High intensity interval training
Arm Title
Resistance training group
Arm Type
Active Comparator
Arm Description
Muscle strengthening
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Behavioral
Intervention Name(s)
High-intensity interval training
Intervention Description
High-intensity interval training sessions will be conducted on cycle ergometers or treadmill with heart rate measured throughout each session.
Intervention Type
Behavioral
Intervention Name(s)
Resistance training
Intervention Description
Resistance exercise will be performed on eight exercises targeting major muscle groups at 60% to 85% of their estimated one-repetition maximum (1RM).
Primary Outcome Measure Information:
Title
Change in fatigue
Description
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)
Secondary Outcome Measure Information:
Title
Change in functional capacity
Description
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)
Title
Change in quality of life
Description
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)
Title
Change in sleep disturbances
Description
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)
Title
Change in somnolence syndrome
Description
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)
Title
Change in insomnia
Description
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)
Title
Change in depression symptoms
Description
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)
Title
Change in executive functions
Description
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)
Title
Change in dyspnea
Description
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)
Title
Adherence
Description
Percentage of completed sessions
Time Frame
Weekly through the intervention (during 8 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Cliniques universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36299392
Citation
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.
Results Reference
derived

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

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