Cystic FibrosisNCT03069625
Sit-to-stand Test in Cystic Fibrosis Children and Adolescents
A study testing Sit-to-stand test and 6-Minute Walk Test in people with Cystic Fibrosis, run by Groupe Hospitalier du Havre at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Sit-to-stand test and 6-Minute Walk Test
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesFrance
- Study dates
- 31 Aug 2017to 24 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Cystic Fibrosis
- Exacerbation-free last month before inclusion
Who cannot join
- Cardiovascular, neurological or musculoskeletal contra-indications to exercise testing
- Other respiratory disease (kyphoscoliosis, asthma ...)
- Exacerbation
- Unability to carry out field tests
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hôpital Côte de Nacre
Caen
Le Havre Hospital
Le Havre, 76290
CHU de Rouen
Rouen, 76000
About this study
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
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.
Read more
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
- Being tested
- Sit-to-stand test, 6-Minute Walk Test
- Keywords
- Cystic Fibrosis, Exercise Testing, Muscular strength, Pediatrics, Quality of life
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sit-to-stand testBehavioural
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 TestBehavioural
CF young patients will perform 2 6MWT tests. Number of repetitions, cardio-respiratory response and physiological adaptations during the second test will be monitored.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: 6-Minute Walk Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between number of repetitions (STS Test) and 6-Minute Walking Distance
Comparison between the results of these two submaximal exercise tests
Measured: 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 assessed using a microRPM Puma manometer.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start31 Aug 2017
- Primary completion24 Jul 2019
- Study completion24 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier du Havre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal Le Roux, MD, Study director, Groupe Hospitalier du Havre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03069625
- Sponsor's protocol ID
- 2016-A01377-44
- Status last verified
- May 2019
- First submitted
- 16 Feb 2017
- Last updated
- 3 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 26363563Ozalevli 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.
PubMed 16806873Hussey 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.
PubMed 15463817Combret 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.
PubMed 33577586
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03069625
- Acronym / sponsor ID
- 2016-A01377-44
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, Exercise Testing, Muscular strength, Pediatrics, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Groupe Hospitalier du HavreUniversity, hospital or other
- Study start
- 31 Aug 2017 (actual)
- Primary completion
- 24 Jul 2019 (actual)
- Study completion
- 24 Jul 2019 (actual)
- First posted
- 3 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sit-to-stand test | Experimental | Behavioral: Sit-to-stand testChildren 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. |
| 6-Minute Walk Test | Active comparator | Behavioral: 6-Minute Walk TestChildren 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Cystic Fibrosis
- Exacerbation-free last month before inclusion
Key exclusion criteria (4 listed)
- Cardiovascular, neurological or musculoskeletal contra-indications to exercise testing
- Other respiratory disease (kyphoscoliosis, asthma ...)
- Exacerbation
- Unability to carry out field tests
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sit-to-stand testCF young patients will perform 2 STS tests. Number of repetitions, cardio-respiratory response and physiological adaptations during the second test will be monitored. | Behavioural | Sit-to-stand test |
| 6-Minute Walk TestCF young patients will perform 2 6MWT tests. Number of repetitions, cardio-respiratory response and physiological adaptations during the second test will be monitored. | Behavioural | 6-Minute Walk Test |
Primary outcome
Correlation between number of repetitions (STS Test) and 6-Minute Walking Distance
Time frame: This outcome will be measured after both tests realization up to 15 minutes.
Comparison between the results of these two submaximal exercise tests
11 secondary outcomes
Correlation between number of repetitions (STS test) and Maximal Inspiratory Pressure (MIP)
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2019.
- Background: PubMed 26363563Radtke 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.
- Background: PubMed 16806873Ozalevli 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.
- Background: PubMed 15463817Hussey 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.
- Derived from this study: PubMed 33577586Combret 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pascal Le Roux, MD study director
Groupe Hospitalier du Havre
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sit-to-stand test and 6-Minute Walk Test in people with Cystic Fibrosis, run by Groupe Hospitalier du Havre at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between number of repetitions (STS Test) and 6-Minute Walking Distance (time frame: This outcome will be measured after both tests realization up to 15 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03069625, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2019.