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

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

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.

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Behavioral: Sit-to-stand test; Behavioral: 6-Minute Walk Test

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Caen, France
    • Hôpital Côte De Nacre
  • Le Havre, France, 76290
    • Le Havre Hospital
  • Rouen, France, 76000
    • CHU de Rouen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Sit-to-stand test; CF young patients will perform 2 STS tests. Number of repetitions, cardio-respiratory response and physiological adaptations during the second test will be monitored.
Active Comparator: 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.	Behavioral: 6-Minute Walk Test; CF young patients will perform 2 6MWT tests. Number of repetitions, cardio-respiratory response and physiological adaptations during the second test will be monitored.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between number of repetitions (STS test) and Maximal Inspiratory Pressure (MIP)	MIP will be assessed using a microRPM Puma manometer.	MIP will be measured after inclusion in the hour before field tests realization.
Correlation between number of repetitions (STS test) and Maximal Expiratory Pressure (MEP)	MEP will be assessed using a MicroRPM Puma manometer.	MEP will be measured after inclusion in the hour before field tests realization.
Correlation between number of repetitions (STS Test) and health-related quality of life	HRQoL will be measured by the Cystic Fibrosis Questionnaire	HRQoL testing will be carried out after inclusion in the hour before field tests realization.
Correlation between number of repetitions (STS Test) and quadriceps strength.	Quadriceps strength will be assessed by handheld dynamometry using a MicroFet II dynamometer.	Quadriceps strength will be assessed after inclusion in the hour before field tests realization.
Correlation between number of repetitions (STS Test) and forced vital capacity (FVC)	FVC will be assessed with non invasive spirometry.	Spirometric test will be carried out before field tests realization.
Correlation between number of repetitions (STS Test) and forced expiratory volume in 1 second (FEV1)	FEV1 will be assessed with non invasive spirometry.	Spirometric test will be carried out in the last 3 months before field tests realization.
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 dyspnea and muscular fatigue.	These outcomes will be assessed using Modified Borg Scale (0-10 points)	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.
Differences in Heart Rate.	These outcomes will be assessed using pulse oximetry.	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.
Differences in Respiratory Rate.	These outcomes will be assessed using pulse oximetry.	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
Differences in Oxygen Saturation.	These outcomes will be assessed using pulse oximetry.	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.

Collaborators and Investigators

• Sponsor: Groupe Hospitalier du Havre
• Investigators: Study Director: Pascal Le Roux, MD, Groupe Hospitalier Du Havre

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2017
• Primary Completion (Actual): July 24, 2019
• Study Completion (Actual): July 24, 2019

Study Registration Dates

• First Submitted: February 16, 2017
• First Submitted That Met QC Criteria: February 27, 2017
• First Posted (Actual): March 3, 2017

Study Record Updates

• Last Update Posted (Actual): September 3, 2019
• Last Update Submitted That Met QC Criteria: August 30, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Quality of life; Cystic Fibrosis; Pediatrics; Muscular strength; Exercise Testing
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: 2016-A01377-44

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No