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

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.
Procedure: Home-based training program
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.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

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