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NCT02512263 Clinical Trial

Assessment of Adherence and Efficiency of a Home-based Training Program on Muscular Strength, Endurance and Qol for Colon Cancer Patients

Colon Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02512263
Other study ID # HBTPCoCa
Secondary ID
Status Recruiting
Phase N/A
First received July 27, 2015
Last updated July 28, 2015
Start date July 2015
Est. completion date July 2017

Study information
Verified date July 2015
Source Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Contact n/a
Is FDA regulated No
Health authority Belgium: Ethics Committee
Study type Interventional

Clinical Trial 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.

Description:

It's a 9-weeks experimentation with 4 moments (every 3 weeks) to do the tests.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date July 2017
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Home-based training program
A home-based training program of 8 exercises to do 5 times a week during 9 weeks

Locations
Country Name City State
Belgium Cliniques universitaires Saint-Luc Brussels

Sponsors (1)
Lead Sponsor Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Muscular strength measured by Microfet 15 minutes No
Secondary Quality of life measured by questionnaire 3 minutes Yes
Secondary Fatigue measured by questionnaire 3 minutes Yes
Secondary Physical activity measured by questionnaire 3 minutes Yes
Secondary Anxiety measured by questionnaire 3 minutes Yes
Secondary Exercise tolerance measured by Six minute walking test 6 minutes No
Secondary Depression measured by questionnaire 3 minutes No
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