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

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain (Other)
• Overall Status: Completed
• CT.gov ID: NCT03276299
• Collaborator: (none)
• Enrollment: 148
• Location: 1
• Arms: 4
• Actual Duration (Months): 12
• Patients Per Site Per Month: 12.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Children	Other: six minute walking test; Other: six minute walking test	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 148 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Learning and Encouragement Effect on 6 Minute Walking Test in Children Between 6 and 12 Years
• Actual Study Start Date: Dec 1, 2015
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: test 1 six minute walking test	Other: six minute walking test; six minute walking test
Experimental: test 2 six minute walking test	Other: six minute walking test; six minute walking test
Experimental: test with encouragement 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

Outcome Measures

Primary Outcome Measures

1. distance [six minutes]

   walked distance

Secondary Outcome Measures

1. heart rate [six minutes]

   heart rate

2. pulsed oxygen saturation [six minutes]

   pulsed oxygen saturation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinique universitaire Saint-Luc	Brussels		Belgium

Sponsors and Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• ClinicalTrials.gov Identifier: NCT03276299
• Other Study ID Numbers: Child6MWT
• First Posted: Sep 8, 2017
• Last Update Posted: Sep 8, 2017
• Last Verified: Sep 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Sep 8, 2017