- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02512263
Assessment of Adherence and Efficiency of a Home-based Training Program on Muscular Strength, Endurance and Qol for Colon Cancer Patients
July 28, 2015 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
It's a 9-weeks experimentation with 4 moments (every 3 weeks) to do the tests.
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Brussels, Belgium
- Recruiting
- Cliniques Universitaires Saint-Luc
-
Contact:
- Sophie DEBOUCHE
- Phone Number: 02 764 16 33
- Email: sophie.debouche@gmail.com
-
Contact:
- Louise CASTAGNE
- Email: louise.castagne@student.uclouvain.be
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
They will have to do all the tests and to follow the home-based training program during 9 weeks.
|
A home-based training program of 8 exercises to do 5 times a week during 9 weeks
|
|
No Intervention: control group
They will have to do all the tests but not to follow the home-based training program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Muscular strength measured by Microfet
Time Frame: 15 minutes
|
15 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Quality of life measured by questionnaire
Time Frame: 3 minutes
|
3 minutes
|
|
Fatigue measured by questionnaire
Time Frame: 3 minutes
|
3 minutes
|
|
Physical activity measured by questionnaire
Time Frame: 3 minutes
|
3 minutes
|
|
Anxiety measured by questionnaire
Time Frame: 3 minutes
|
3 minutes
|
|
Exercise tolerance measured by Six minute walking test
Time Frame: 6 minutes
|
6 minutes
|
|
Depression measured by questionnaire
Time Frame: 3 minutes
|
3 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2015
Primary Completion (Anticipated)
October 1, 2015
Study Completion (Anticipated)
July 1, 2017
Study Registration Dates
First Submitted
July 27, 2015
First Submitted That Met QC Criteria
July 28, 2015
First Posted (Estimate)
July 30, 2015
Study Record Updates
Last Update Posted (Estimate)
July 30, 2015
Last Update Submitted That Met QC Criteria
July 28, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HBTPCoCa
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.