Cystic FibrosisNCT04058548
Clinical Utility of the 1-minute Sit to Stand Test as a Measure of Submaximal Exercise Tolerance in Patients With Cystic Fibrosis During Acute Pulmonary Exacerbation
A study testing Sit to stand test in people with Cystic Fibrosis, run by Boston Children's Hospital at 1 site in United States.
Trial summary
The aim of this study is to assess whether the 1 minute Sit to Stand (STS) test can be used as a measure of submaximal endurance during a pulmonary exacerbation of Cystic Fibrosis (CF) for patients in the acute care setting. Read more about this study
- Who is it for?
- Ages 6 to 35 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Sit to stand test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2019to 12 May 2021
- 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 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patients age 6-35 with cystic fibrosis who are admitted for a pulmonary exacerbation and receive ongoing physical therapy throughout their admission.
Who cannot join
- patients with cystic fibrosis who are under the age of 6,
- patients with cystic fibrosis who are not admitted for a pulmonary exacerbation,
- patients with cystic fibrosis who are not being followed regularly by physical therapy (>5x/week) throughout their inpatient admission,
- patients with cystic fibrosis who are unable to follow instructions for standardized testing,
- patients with cystic fibrosis who are not medically stable to participate in submaximal exercise testing.
- patients whose inpatient admission is anticipated to be <1 week.
- Patients who are readmitted to the hospital within the year will not be included in the study more than once.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
The aim of this study is to assess whether the 1 minute Sit to Stand (STS) test can be used as a measure of submaximal endurance during a pulmonary exacerbation of Cystic Fibrosis (CF) for patients in the acute care setting. We hypothesize that if the STS test is a valid measure of submaximal cardiovascular endurance, it will moderately correlate with 6 minute walk distance (6MWD).
- Conditions
- Cystic Fibrosis
- Being tested
- Sit to stand test
- Keywords
- cystic fibrosis, walk test
- 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 testDiagnostic test
Also called 6 minute walk test
Participants will complete a sit to stand test in addition to a 6 minute walk test
| Study group | Role | What they receive |
|---|---|---|
| 6MWT and STS | Experimental | All participates will receive 6MWT and STS test Receives: Diagnostic Test: Sit to stand test |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-minute STS repetitions:
Number of STS completed
Measured: 1 minute
1 minute STS power:
number of STS completed in 1 minute multiplied by bodyweight in pounds
Measured: 1 minute
6 Minute Walk Distance (6MWD):
total distance in feet completed during test
Measured: 6 minutes
6MWT power
total distance in feet multiplied by bodyweight in pounds
Measured: 6 minutes
Secondary outcomes (4)
Heart rate
beats per minute
Measured: 1 minute
Oxygen saturation
percentage via pulse oximetry
Measured: 1-6 minutes
Respiratory rate
breaths per minute
Measured: 1-6 min
Rating of perceived exertion
rating via Borg scale for perceived exertion: 0-10 with 0 being no breathlessness and 10 being maximal breathlessness
Measured: 6 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start5 Sep 2019
- Primary completion12 May 2021
- Study completion12 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jenna Gondelman, Boston Children's Hospital
- Investigators
- Jenna Gondelman, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04058548
- Sponsor's protocol ID
- IRB-P00031139
- Status last verified
- Jul 2021
- First submitted
- 14 Aug 2019
- Last updated
- 16 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Andrade Lima C, Dornelas de Andrade A, Campos SL, Brandao DC, Mourato IP, Britto MCA. Six-minute walk test as a determinant of the functional capacity of children and adolescents with cystic fibrosis: A systematic review. Respir Med. 2018 Apr;137:83-88. doi: 10.1016/j.rmed.2018.02.016. Epub 2018 Feb 26.
PubMed 29605218Gruet M, Peyre-Tartaruga LA, Mely L, Vallier JM. The 1-Minute Sit-to-Stand Test in Adults With Cystic Fibrosis: Correlations With Cardiopulmonary Exercise Test, 6-Minute Walk Test, and Quadriceps Strength. Respir Care. 2016 Dec;61(12):1620-1628. doi: 10.4187/respcare.04821. Epub 2016 Nov 15.
PubMed 27899540Radtke 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 26363563Okuro RT, de Oliveira Ribeiro MA, Ribeiro JD, Minsky RC, Schivinski CI. Alternative Indexes to Estimate the Functional Capacity From the 6-Minute Walk Test in Children and Adolescents With Cystic Fibrosis. Respir Care. 2017 Mar;62(3):324-332. doi: 10.4187/respcare.04625. Epub 2017 Jan 3.
PubMed 28049743Vaidya T, de Bisschop C, Beaumont M, Ouksel H, Jean V, Dessables F, Chambellan A. Is the 1-minute sit-to-stand test a good tool for the evaluation of the impact of pulmonary rehabilitation? Determination of the minimal important difference in COPD. Int J Chron Obstruct Pulmon Dis. 2016 Oct 19;11:2609-2616. doi: 10.2147/COPD.S115439. eCollection 2016.
PubMed 27799759
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Utility of the 1-minute Sit to Stand Test as a Measure of Submaximal Exercise Tolerance in Patients With Cystic Fibrosis During Acute Pulmonary Exacerbation
- ClinicalTrials.gov ID
- NCT04058548
- Acronym / sponsor ID
- IRB-P00031139
- Conditions
- Cystic Fibrosis
- Keywords
- cystic fibrosis, walk test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 5 Sep 2019 (actual)
- Primary completion
- 12 May 2021 (actual)
- Study completion
- 12 May 2021 (actual)
- First posted
- 15 Aug 2019 (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.
The aim of this study is to assess whether the 1 minute Sit to Stand (STS) test can be used as a measure of submaximal endurance during a pulmonary exacerbation of Cystic Fibrosis (CF) for patients in the acute care setting. We hypothesize that if the STS test is a valid measure of submaximal cardiovascular endurance, it will moderately correlate with 6 minute walk distance (6MWD).
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 6MWT and STS | Experimental | Diagnostic Test: Sit to stand testAll participates will receive 6MWT and STS test |
Who may qualify
- Ages
- 6 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- patients age 6-35 with cystic fibrosis who are admitted for a pulmonary exacerbation and receive ongoing physical therapy throughout their admission.
Key exclusion criteria (7 listed)
- patients with cystic fibrosis who are under the age of 6,
- patients with cystic fibrosis who are not admitted for a pulmonary exacerbation,
- patients with cystic fibrosis who are not being followed regularly by physical therapy (>5x/week) throughout their inpatient admission,
- patients with cystic fibrosis who are unable to follow instructions for standardized testing,
- patients with cystic fibrosis who are not medically stable to participate in submaximal exercise testing.
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 testAlso: 6 minute walk testParticipants will complete a sit to stand test in addition to a 6 minute walk test | Diagnostic test | 6MWT and STS |
Primary outcome
1-minute STS repetitions:
Time frame: 1 minute
Number of STS completed
1 minute STS power:
Time frame: 1 minute
number of STS completed in 1 minute multiplied by bodyweight in pounds
6 Minute Walk Distance (6MWD):
Time frame: 6 minutes
total distance in feet completed during test
6MWT power
Time frame: 6 minutes
total distance in feet multiplied by bodyweight in pounds
4 secondary outcomes
Heart rate
Time frame: 1 minute
Oxygen saturation
Time frame: 1-6 minutes
Respiratory rate
Time frame: 1-6 min
Rating of perceived exertion
Time frame: 6 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 16 Jul 2021.
- Background: PubMed 29605218Andrade Lima C, Dornelas de Andrade A, Campos SL, Brandao DC, Mourato IP, Britto MCA. Six-minute walk test as a determinant of the functional capacity of children and adolescents with cystic fibrosis: A systematic review. Respir Med. 2018 Apr;137:83-88. doi: 10.1016/j.rmed.2018.02.016. Epub 2018 Feb 26.
- Background: PubMed 27899540Gruet M, Peyre-Tartaruga LA, Mely L, Vallier JM. The 1-Minute Sit-to-Stand Test in Adults With Cystic Fibrosis: Correlations With Cardiopulmonary Exercise Test, 6-Minute Walk Test, and Quadriceps Strength. Respir Care. 2016 Dec;61(12):1620-1628. doi: 10.4187/respcare.04821. Epub 2016 Nov 15.
- 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 28049743Okuro RT, de Oliveira Ribeiro MA, Ribeiro JD, Minsky RC, Schivinski CI. Alternative Indexes to Estimate the Functional Capacity From the 6-Minute Walk Test in Children and Adolescents With Cystic Fibrosis. Respir Care. 2017 Mar;62(3):324-332. doi: 10.4187/respcare.04625. Epub 2017 Jan 3.
- Background: PubMed 27799759Vaidya T, de Bisschop C, Beaumont M, Ouksel H, Jean V, Dessables F, Chambellan A. Is the 1-minute sit-to-stand test a good tool for the evaluation of the impact of pulmonary rehabilitation? Determination of the minimal important difference in COPD. Int J Chron Obstruct Pulmon Dis. 2016 Oct 19;11:2609-2616. doi: 10.2147/COPD.S115439. eCollection 2016.
- Individual participant dataSharing planned: No
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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.
Jenna Gondelman principal investigator
Boston Children's Hospital
1 site 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 in people with Cystic Fibrosis, run by Boston Children's Hospital at 1 site in United States.
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 1 inclusion and 7 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 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
1-minute STS repetitions: (time frame: 1 minute). The study lists 4 primary outcomes in all. 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 NCT04058548, which also lists 5 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 16 Jul 2021.