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

Cystic Fibrosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03069625
• Other study ID #: 2016-A01377-44
• Status: Completed
• Phase: N/A
• Start date: August 31, 2017
• Est. completion date: July 24, 2019

Study information

• Verified date: May 2019
• Source: Groupe Hospitalier du Havre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 24, 2019
• Est. primary completion date: July 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Hôpital Côte de Nacre	Caen
France	Le Havre Hospital	Le Havre
France	CHU de Rouen	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier du Havre

Country where clinical trial is conducted

France, 

References & Publications (3)

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. — View 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. Epub 2006 Jun 27. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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
Secondary	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.