Clinical trial NCT03069625: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: Cystic Fibrosis
Exercise Testing
Muscular strength
Pediatrics
Quality of life
Lead sponsor: Groupe Hospitalier du Havre
Sponsor class: OTHER
First posted: 2017-03-03
Enrollment: 36
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

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.


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

Primary outcomes:
measure: Correlation between number of repetitions (STS Test) and 6-Minute Walking Distance
timeFrame: This outcome will be measured after both tests realization up to 15 minutes.
Secondary outcomes:
measure: Correlation between number of repetitions (STS test) and Maximal Inspiratory Pressure (MIP)
timeFrame: MIP will be measured after inclusion in the hour before field tests realization.
measure: Correlation between number of repetitions (STS test) and Maximal Expiratory Pressure (MEP)
timeFrame: MEP will be measured after inclusion in the hour before field tests realization.
measure: Correlation between number of repetitions (STS Test) and health-related quality of life
timeFrame: HRQoL testing will be carried out after inclusion in the hour before field tests realization.
measure: Correlation between number of repetitions (STS Test) and quadriceps strength.
timeFrame: Quadriceps strength will be assessed after inclusion in the hour before field tests realization.
measure: Correlation between number of repetitions (STS Test) and forced vital capacity (FVC)
timeFrame: Spirometric test will be carried out before field tests realization.
measure: Correlation between number of repetitions (STS Test) and forced expiratory volume in 1 second (FEV1)
timeFrame: Spirometric test will be carried out in the last 3 months before field tests realization.
measure: Correlation between number of repetitions (STS Test) and number of exacerbations / year.
timeFrame: 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.
measure: Differences in dyspnea and muscular fatigue.
timeFrame: 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.
measure: Differences in Heart Rate.
timeFrame: 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.
measure: Differences in Respiratory Rate.
timeFrame: 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
measure: Differences in Oxygen Saturation.
timeFrame: 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.
Other outcomes:
Locations:
city: Caen
country: France
facility: Hôpital Côte de Nacre
city: Le Havre
country: France
facility: Le Havre Hospital
city: Rouen
country: France
facility: CHU de Rouen
Study officials:
affiliation: Groupe Hospitalier du Havre
name: Pascal Le Roux, MD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.