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

NCT03069625 | Completed

• 1 other identifier: 2016-A01377-44
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

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.

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis; Exercise Testing; Muscular strength; Pediatrics; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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.

• 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.

• 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.

• Correlation between number of repetitions (STS Test) and quadriceps strength.

  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)

  Spirometric test will be carried out before field tests realization.

Study Arms (2)

Sit-to-stand test

EXPERIMENTAL

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

6-Minute Walk Test

ACTIVE COMPARATOR

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

Interventions

Sit-to-stand test BEHAVIORAL

CF young patients will perform 2 STS tests. Number of repetitions, cardio-respiratory response and physiological adaptations during the second test will be monitored.

Sit-to-stand test

6-Minute Walk Test BEHAVIORAL

CF young patients will perform 2 6MWT tests. Number of repetitions, cardio-respiratory response and physiological adaptations during the second test will be monitored.

6-Minute Walk Test

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Cystic Fibrosis

You may not qualify if:

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

Sponsors & Collaborators

• Groupe Hospitalier du Havre: lead

Study Sites (3)

Hôpital Côte de Nacre

Caen, France

Location

Le Havre Hospital

Le Havre, 76290, France

Location

CHU de Rouen

Rouen, 76000, France

Location

Related Publications (4)

• 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.

  PMID: 26363563 BACKGROUND

• 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.

  PMID: 16806873 BACKGROUND

• 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.

  PMID: 15463817 BACKGROUND

• 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.

  PMID: 33577586 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Pascal Le Roux, MD

  Groupe Hospitalier du Havre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2017
• First Posted: March 3, 2017
• Study Start: August 31, 2017
• Primary Completion: July 24, 2019
• Study Completion: July 24, 2019
• Last Updated: September 3, 2019

Record last verified: 2019-05

Locations

FR (3)