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

NCT ID: NCT03069625

Last Updated: 2019-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-31

Study Completion Date

2019-07-24

Brief Summary

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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

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Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Sit-to-stand test

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

6-Minute Walk Test

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Groupe Hospitalier du Havre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pascal Le Roux, MD

Role: STUDY_DIRECTOR

Groupe Hospitalier du Havre

Locations

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Hôpital Côte de Nacre

Caen, , France

Site Status

Le Havre Hospital

Le Havre, , France

Site Status

CHU de Rouen

Rouen, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 26363563 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16806873 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15463817 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33577586 (View on PubMed)

Other Identifiers

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2016-A01377-44

Identifier Type: -

Identifier Source: org_study_id

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