Back to resultsAssessment of Adherence and Efficiency of a Home-based Training Program on Muscular Strength, Endurance and Qol for Colon Cancer Patients
Primary Purpose
Colon Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Home-based training program
Sponsored by
About this trial
This is an interventional treatment trial for Colon Cancer
Eligibility Criteria
Inclusion Criteria:
- Colon cancer patients treated by chemotherapy adjuvant
Exclusion Criteria:
- Patients who have metastasis
- Patients hospitalized during the experimentation
- Patients who have major orthopedic or neurologic problems
Sites / Locations
- Cliniques universitaires Saint-LucRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
control group
Arm Description
They will have to do all the tests and to follow the home-based training program during 9 weeks.
They will have to do all the tests but not to follow the home-based training program.
Outcomes
Primary Outcome Measures
Muscular strength measured by Microfet
Secondary Outcome Measures
Quality of life measured by questionnaire
Fatigue measured by questionnaire
Physical activity measured by questionnaire
Anxiety measured by questionnaire
Exercise tolerance measured by Six minute walking test
Depression measured by questionnaire
Full Information
NCT ID
NCT02512263
First Posted
July 27, 2015
Last Updated
July 28, 2015
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1. Study Identification
Unique Protocol Identification Number
NCT02512263
Brief Title
Assessment of Adherence and Efficiency of a Home-based Training Program on Muscular Strength, Endurance and Qol for Colon Cancer Patients
Official Title
Assessment of Adherence and Efficiency of a Home-based Training Program on the Muscular Strength, the Endurance and the Quality of Life for Colon Cancer Patients Treated by Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
July 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
4. Oversight
5. Study Description
Brief Summary
The purpose is to assess the adherence and the efficiency of a home-based training program on muscular strength, endurance and the quality of life, fatigue, physical activity, anxiety and depression for colon cancer patient treated by chemotherapy.
Detailed Description
It's a 9-weeks experimentation with 4 moments (every 3 weeks) to do the tests.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
They will have to do all the tests and to follow the home-based training program during 9 weeks.
Arm Title
control group
Arm Type
No Intervention
Arm Description
They will have to do all the tests but not to follow the home-based training program.
Intervention Type
Procedure
Intervention Name(s)
Home-based training program
Intervention Description
A home-based training program of 8 exercises to do 5 times a week during 9 weeks
Primary Outcome Measure Information:
Title
Muscular strength measured by Microfet
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Quality of life measured by questionnaire
Time Frame
3 minutes
Title
Fatigue measured by questionnaire
Time Frame
3 minutes
Title
Physical activity measured by questionnaire
Time Frame
3 minutes
Title
Anxiety measured by questionnaire
Time Frame
3 minutes
Title
Exercise tolerance measured by Six minute walking test
Time Frame
6 minutes
Title
Depression measured by questionnaire
Time Frame
3 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Colon cancer patients treated by chemotherapy adjuvant
Exclusion Criteria:
Patients who have metastasis
Patients hospitalized during the experimentation
Patients who have major orthopedic or neurologic problems
Facility Information:
Facility Name
Cliniques universitaires Saint-Luc
City
Brussels
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie DEBOUCHE
Phone
02 764 16 33
Email
sophie.debouche@gmail.com
First Name & Middle Initial & Last Name & Degree
Louise CASTAGNE
Email
louise.castagne@student.uclouvain.be
12. IPD Sharing Statement
Learn more about this trial
Assessment of Adherence and Efficiency of a Home-based Training Program on Muscular Strength, Endurance and Qol for Colon Cancer Patients
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