Sit-to-stand Test in Cystic Fibrosis Children and Adolescents

Not Applicable

Completed

• Conditions: Cystic Fibrosis
• Interventions: Behavioral: Sit-to-stand test; Behavioral: 6-Minute Walk Test

• Registration Number: NCT03069625
• Lead Sponsor: Groupe Hospitalier du Havre

Brief Summary

Cystic fibrosis (CF) is a chronic hereditary respiratory disease. Exercise testing is part of CF patients regular assessment.

Cardio-Pulmonary Exercise Testing (CPET) is currently considered as the gold standard to assess physical capacities. However, simple field tests are emerging. These tests are easier to perform especially in a population of CF children and adolescents.

The 1minute Sit-To-Stand test have recently been evaluated in CF adults. This test correlates with maximal oxygen consumption during CPET.

The investigators hypothesized that this test also correlates with 6-Minute Walking distance (during a 6-min Walk Test), quadriceps strength, respiratory muscles strength and health-related quality of life.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-16
• Study First Submitted QC: 2017-02-27
• Study First Posted: 2017-03-03
• Study Start: 2017-08-31
• Status Verified: 2019-05
• Primary Completion: 2019-07-24
• Study Completion: 2019-07-24
• Last Update Submitted: 2019-08-30
• Last Update Posted: 2019-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Cystic Fibrosis
• Exacerbation-free last month before inclusion

Exclusion Criteria

• Cardiovascular, neurological or musculoskeletal contra-indications to exercise testing
• Other respiratory disease (kyphoscoliosis, asthma ...)
• Exacerbation
• Unability to carry out field tests

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sit-to-stand test	Sit-to-stand test	Children and adolescents will perform 2 STS tests. First one is used to eliminate learning effect. Number of repetitions will be noted at the end of the second test.
6-Minute Walk Test	6-Minute Walk Test	Children and adolescents will perform 2 6MWT tests. First one is used to eliminate learning effect. Number of repetitions will be noted at the end of the second test.

Primary Outcome Measures

Name	Time	Method
Correlation between number of repetitions (STS Test) and 6-Minute Walking Distance	This outcome will be measured after both tests realization up to 15 minutes.	Comparison between the results of these two submaximal exercise tests

Secondary Outcome Measures

Name	Time	Method
Correlation between number of repetitions (STS test) and Maximal Inspiratory Pressure (MIP)	MIP will be measured after inclusion in the hour before field tests realization.	MIP will be assessed using a microRPM Puma manometer.
Correlation between number of repetitions (STS test) and Maximal Expiratory Pressure (MEP)	MEP will be measured after inclusion in the hour before field tests realization.	MEP will be assessed using a MicroRPM Puma manometer.
Correlation between number of repetitions (STS Test) and health-related quality of life	HRQoL testing will be carried out after inclusion in the hour before field tests realization.	HRQoL will be measured by the Cystic Fibrosis Questionnaire
Differences in dyspnea and muscular fatigue.	These outcomes will be assessed during both field tests. These tests will be separate by a 30 minutes rest period. Date will be collected at the end of each test up to 15 minutes.	These outcomes will be assessed using Modified Borg Scale (0-10 points)
Correlation between number of repetitions (STS Test) and forced vital capacity (FVC)	Spirometric test will be carried out before field tests realization.	FVC will be assessed with non invasive spirometry.
Correlation between number of repetitions (STS Test) and number of exacerbations / year.	Number of exacerbations / year will assess the number of exacerbations in the last year before inclusion and will be assessed during the initial survey in the hour before field test realization.
Differences in Respiratory Rate.	These outcomes will be assessed during both field tests. These tests will be separate by a 30 minutes rest period. Date will be collected at the end of each test up to 15 minutes	These outcomes will be assessed using pulse oximetry.
Correlation between number of repetitions (STS Test) and quadriceps strength.	Quadriceps strength will be assessed after inclusion in the hour before field tests realization.	Quadriceps strength will be assessed by handheld dynamometry using a MicroFet II dynamometer.
Correlation between number of repetitions (STS Test) and forced expiratory volume in 1 second (FEV1)	Spirometric test will be carried out in the last 3 months before field tests realization.	FEV1 will be assessed with non invasive spirometry.
Differences in Heart Rate.	These outcomes will be assessed during both field tests. These tests will be separate by a 30 minutes rest period. Date will be collected at the end of each test up to 15 minutes.	These outcomes will be assessed using pulse oximetry.
Differences in Oxygen Saturation.	These outcomes will be assessed during both field tests. These tests will be separate by a 30 minutes rest period. Date will be collected at the end of each test up to 15 minutes.	These outcomes will be assessed using pulse oximetry.

Trial Locations

Locations (3)

CHU de Rouen; 🇫🇷 Rouen, France

Hôpital Côte de Nacre; 🇫🇷 Caen, France

Le Havre Hospital; 🇫🇷 Le Havre, France