Learning and Encouragement Effect on 6 Minute Walking Test in Children Between 6 and 12 Years

September 6, 2017 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Evaluation of the learning and encouragement effect on six minutes walking test in children under 12 years

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

148

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

  • Belgium
      • Brussels, Belgium
        • Clinique Universitaire Saint-Luc

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

6 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy subjects

Exclusion Criteria:

  • acute or chronic lung, cardiac or neuromuscular disease
  • at risk of- or overweight (BMI higher than 85th percentile for children of the same age and sex)
  • a motor disability

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: test 1
six minute walking test
Other: six minute walking test
six minute walking test
Other: six minute walking test
six minute walking test with encouragement
Experimental: test 2
six minute walking test
Other: six minute walking test
six minute walking test
Other: six minute walking test
six minute walking test with encouragement
Experimental: test with encouragement
six minute walking test
Other: six minute walking test
six minute walking test
Other: six minute walking test
six minute walking test with encouragement
Active Comparator: test without encouragement
six minute walking test
Other: six minute walking test
six minute walking test
Other: six minute walking test
six minute walking test with encouragement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
distance
Time Frame: six minutes
walked distance
six minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
heart rate
Time Frame: six minutes
heart rate
six minutes
pulsed oxygen saturation
Time Frame: six minutes
pulsed oxygen saturation
six 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

December 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

September 6, 2017

First Submitted That Met QC Criteria

September 6, 2017

First Posted (Actual)

September 8, 2017

Study Record Updates

Last Update Posted (Actual)

September 8, 2017

Last Update Submitted That Met QC Criteria

September 6, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • Child6MWT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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