NCT02318238

Brief Summary

The purpose of this study is to find an alternative to the six minute walk test by validating six minute step test and four metre gait speed in healthy children. Both tests were previously validated in adults and are easier to achieve in non-hospital settings.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Feb 2014

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

February 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 17, 2014

Completed
Last Updated

December 17, 2014

Status Verified

December 1, 2014

Enrollment Period

Same day

First QC Date

December 4, 2014

Last Update Submit

December 11, 2014

Conditions

Keywords

evaluationexercise tolerancehealthy children6MWT

Outcome Measures

Primary Outcomes (6)

  • Walked distance

    The distance walked by subjects during a 6 minute walk test

    At 6 minutes

  • Steps count

    Steps number raised and lowered by subject during a 6 minute step test

    At 6 minutes

  • Time

    Time to walk four metres

    at 1 minute

  • 6MWT speed

    Subjects speed (number of metres/minute) during the 6 minute walk test

    at 6 minutes

  • 6MST speed

    Number of steps/minute during the 6 minute step test

    at 6 minutes

  • 4MGS speed

    Number of metres/second during the four metre gait speed

    at 1 minute

Secondary Outcomes (4)

  • Dyspnea

    at 6 minutes

  • Perceived exertion

    at 6 minutes

  • Heart rate

    at 6 minutes

  • Oxygen saturation

    at 6 minutes

Study Arms (3)

6 minute walking test

ACTIVE COMPARATOR

walking during 6 minutes

Other: 6 minutes walking test

6 minute step test

EXPERIMENTAL

stepping during 6 minutes

Other: 6 minutes step test

4 meter gait speed

EXPERIMENTAL

walking as fast as possible on 4 meters

Other: 4 meters gait speed

Interventions

Also known as: walk during 6 minutes as fast as possible
6 minute walking test
Also known as: up and down a step during 6 minutes as fast as possible
6 minute step test
Also known as: walk a four metre distance
4 meter gait speed

Eligibility Criteria

Age5 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • healthy

You may not qualify if:

  • a lung disease
  • an overweight
  • an orthopedic disability which can slow down the subject during tests execution

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique universitaire Saint-Luc

Brussels, Belgium

Location

MeSH Terms

Interventions

Exercise Test

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Officials

  • Sophie De Wulf

    UCL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor in Physiotherapy

Study Record Dates

First Submitted

December 4, 2014

First Posted

December 17, 2014

Study Start

February 1, 2014

Primary Completion

February 1, 2014

Study Completion

October 1, 2014

Last Updated

December 17, 2014

Record last verified: 2014-12

Locations