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

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Sit-to-stand test
6-Minute Walk Test
Sponsored by
Groupe Hospitalier du Havre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cystic Fibrosis focused on measuring Cystic Fibrosis, Exercise Testing, Muscular strength, Pediatrics, Quality of life

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Côte de Nacre
  • Le Havre Hospital
  • CHU de Rouen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sit-to-stand test

6-Minute Walk Test

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Correlation between number of repetitions (STS Test) and 6-Minute Walking Distance
Comparison between the results of these two submaximal exercise tests

Secondary Outcome Measures

Correlation between number of repetitions (STS test) and Maximal Inspiratory Pressure (MIP)
MIP will be assessed using a microRPM Puma manometer.
Correlation between number of repetitions (STS test) and Maximal Expiratory Pressure (MEP)
MEP will be assessed using a MicroRPM Puma manometer.
Correlation between number of repetitions (STS Test) and health-related quality of life
HRQoL will be measured by the Cystic Fibrosis Questionnaire
Correlation between number of repetitions (STS Test) and quadriceps strength.
Quadriceps strength will be assessed by handheld dynamometry using a MicroFet II dynamometer.
Correlation between number of repetitions (STS Test) and forced vital capacity (FVC)
FVC will be assessed with non invasive spirometry.
Correlation between number of repetitions (STS Test) and forced expiratory volume in 1 second (FEV1)
FEV1 will be assessed with non invasive spirometry.
Correlation between number of repetitions (STS Test) and number of exacerbations / year.
Differences in dyspnea and muscular fatigue.
These outcomes will be assessed using Modified Borg Scale (0-10 points)
Differences in Heart Rate.
These outcomes will be assessed using pulse oximetry.
Differences in Respiratory Rate.
These outcomes will be assessed using pulse oximetry.
Differences in Oxygen Saturation.
These outcomes will be assessed using pulse oximetry.

Full Information

First Posted
February 16, 2017
Last Updated
August 30, 2019
Sponsor
Groupe Hospitalier du Havre
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1. Study Identification

Unique Protocol Identification Number
NCT03069625
Brief Title
Sit-to-stand Test in Cystic Fibrosis Children and Adolescents
Official Title
Sit-to-stand Test Use in Children and Adolescents With Cystic Fibrosis : Correlations With 6-Minute Walking Test, Quadriceps and Respiratory Muscle Strength and Health Related Quality of Life
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
August 31, 2017 (Actual)
Primary Completion Date
July 24, 2019 (Actual)
Study Completion Date
July 24, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Groupe Hospitalier du Havre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Cystic Fibrosis, Exercise Testing, Muscular strength, Pediatrics, Quality of life

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sit-to-stand test
Arm Type
Experimental
Arm Description
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.
Arm Title
6-Minute Walk Test
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sit-to-stand test
Intervention Description
CF young patients will perform 2 STS tests. Number of repetitions, cardio-respiratory response and physiological adaptations during the second test will be monitored.
Intervention Type
Behavioral
Intervention Name(s)
6-Minute Walk Test
Intervention Description
CF young patients will perform 2 6MWT tests. Number of repetitions, cardio-respiratory response and physiological adaptations during the second test will be monitored.
Primary Outcome Measure Information:
Title
Correlation between number of repetitions (STS Test) and 6-Minute Walking Distance
Description
Comparison between the results of these two submaximal exercise tests
Time Frame
This outcome will be measured after both tests realization up to 15 minutes.
Secondary Outcome Measure Information:
Title
Correlation between number of repetitions (STS test) and Maximal Inspiratory Pressure (MIP)
Description
MIP will be assessed using a microRPM Puma manometer.
Time Frame
MIP will be measured after inclusion in the hour before field tests realization.
Title
Correlation between number of repetitions (STS test) and Maximal Expiratory Pressure (MEP)
Description
MEP will be assessed using a MicroRPM Puma manometer.
Time Frame
MEP will be measured after inclusion in the hour before field tests realization.
Title
Correlation between number of repetitions (STS Test) and health-related quality of life
Description
HRQoL will be measured by the Cystic Fibrosis Questionnaire
Time Frame
HRQoL testing will be carried out after inclusion in the hour before field tests realization.
Title
Correlation between number of repetitions (STS Test) and quadriceps strength.
Description
Quadriceps strength will be assessed by handheld dynamometry using a MicroFet II dynamometer.
Time Frame
Quadriceps strength will be assessed after inclusion in the hour before field tests realization.
Title
Correlation between number of repetitions (STS Test) and forced vital capacity (FVC)
Description
FVC will be assessed with non invasive spirometry.
Time Frame
Spirometric test will be carried out before field tests realization.
Title
Correlation between number of repetitions (STS Test) and forced expiratory volume in 1 second (FEV1)
Description
FEV1 will be assessed with non invasive spirometry.
Time Frame
Spirometric test will be carried out in the last 3 months before field tests realization.
Title
Correlation between number of repetitions (STS Test) and number of exacerbations / year.
Time Frame
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.
Title
Differences in dyspnea and muscular fatigue.
Description
These outcomes will be assessed using Modified Borg Scale (0-10 points)
Time Frame
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.
Title
Differences in Heart Rate.
Description
These outcomes will be assessed using pulse oximetry.
Time Frame
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.
Title
Differences in Respiratory Rate.
Description
These outcomes will be assessed using pulse oximetry.
Time Frame
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
Title
Differences in Oxygen Saturation.
Description
These outcomes will be assessed using pulse oximetry.
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascal Le Roux, MD
Organizational Affiliation
Groupe Hospitalier du Havre
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital Côte de Nacre
City
Caen
Country
France
Facility Name
Le Havre Hospital
City
Le Havre
ZIP/Postal Code
76290
Country
France
Facility Name
CHU de Rouen
City
Rouen
ZIP/Postal Code
76000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
26363563
Citation
Radtke T, Puhan MA, Hebestreit H, Kriemler S. The 1-min sit-to-stand test--A simple functional capacity test in cystic fibrosis? J Cyst Fibros. 2016 Mar;15(2):223-6. doi: 10.1016/j.jcf.2015.08.006. Epub 2015 Sep 9.
Results Reference
background
PubMed Identifier
16806873
Citation
Ozalevli S, Ozden A, Itil O, Akkoclu A. Comparison of the Sit-to-Stand Test with 6 min walk test in patients with chronic obstructive pulmonary disease. Respir Med. 2007 Feb;101(2):286-93. doi: 10.1016/j.rmed.2006.05.007. Epub 2006 Jun 27.
Results Reference
background
PubMed Identifier
15463817
Citation
Hussey J, Gormley J, Leen G, Greally P. Peripheral muscle strength in young males with cystic fibrosis. J Cyst Fibros. 2002 Sep;1(3):116-21. doi: 10.1016/s1569-1993(02)00074-7.
Results Reference
background
PubMed Identifier
33577586
Citation
Combret Y, Boujibar F, Gennari C, Medrinal C, Sicinski S, Bonnevie T, Gravier FE, Laurans M, Marguet C, Le Roux P, Lamia B, Prieur G, Reychler G. Measurement properties of the one-minute sit-to-stand test in children and adolescents with cystic fibrosis: A multicenter randomized cross-over trial. PLoS One. 2021 Feb 12;16(2):e0246781. doi: 10.1371/journal.pone.0246781. eCollection 2021.
Results Reference
derived

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

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