Clinical trial NCT04058548: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: cystic fibrosis
walk test
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2019-08-15
Enrollment: 27
Sex: ALL
Minimum age (years): 6
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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).


Eligibility criteria: Inclusion Criteria:

* patients age 6-35 with cystic fibrosis who are admitted for a pulmonary exacerbation and receive ongoing physical therapy throughout their admission.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 1-minute STS repetitions:
timeFrame: 1 minute
measure: 1 minute STS power:
timeFrame: 1 minute
measure: 6 Minute Walk Distance (6MWD):
timeFrame: 6 minutes
measure: 6MWT power
timeFrame: 6 minutes
Secondary outcomes:
measure: Heart rate
timeFrame: 1 minute
measure: Oxygen saturation
timeFrame: 1-6 minutes
measure: Respiratory rate
timeFrame: 1-6 min
measure: Rating of perceived exertion
timeFrame: 6 minutes
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Jenna Gondelman
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Gruet 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.
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: Okuro 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.
citation: Vaidya 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.