NCT03276299

Brief Summary

Evaluation of the learning and encouragement effect on six minutes walking test in children under 12 years

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2017

Completed
Last Updated

September 8, 2017

Status Verified

September 1, 2017

Enrollment Period

Same day

First QC Date

September 6, 2017

Last Update Submit

September 6, 2017

Conditions

Healthy Children

Outcome Measures

Primary Outcomes (1)

  • distance

    walked distance

    six minutes

Secondary Outcomes (2)

  • heart rate

    six minutes

  • pulsed oxygen saturation

    six minutes

Study Arms (4)

test 1

ACTIVE COMPARATOR

six minute walking test

Other: six minute walking test

test 2

EXPERIMENTAL

six minute walking test

Other: six minute walking test

test with encouragement

EXPERIMENTAL

six minute walking test

Other: six minute walking test

test without encouragement

ACTIVE COMPARATOR

six minute walking test

Other: six minute walking test

Interventions

six minute walking testOTHER

six minute walking test

test 1test 2test without encouragement

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • healthy subjects

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique universitaire Saint-Luc

Brussels, Belgium

Location

Related Publications (1)

  • Morales Mestre N, Audag N, Caty G, Reychler G. Learning and Encouragement Effects on Six-Minute Walking Test in Children. J Pediatr. 2018 Jul;198:98-103. doi: 10.1016/j.jpeds.2018.02.073. Epub 2018 Apr 24.

    PMID: 29703575DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2017

First Posted

September 8, 2017

Study Start

December 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2016

Last Updated

September 8, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)