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

Cystic Fibrosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04058548
• Other study ID #: IRB-P00031139
• Status: Completed
• Phase: N/A
• Start date: September 5, 2019
• Est. completion date: May 12, 2021

Study information

• Verified date: July 2021
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: May 12, 2021
• Est. primary completion date: May 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Diagnostic Test:
• Sit to stand test
Participants will complete a sit to stand test in addition to a 6 minute walk test

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (5)

Andrade Lima C, Dornelas de Andrade A, Campos SL, Brandão 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. Review. — View Citation

Gruet M, Peyré-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. Epub 2016 Nov 15. — View 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. — 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

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. eCollection 2016. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1-minute STS repetitions:	Number of STS completed	1 minute
Primary	1 minute STS power:	number of STS completed in 1 minute multiplied by bodyweight in pounds	1 minute
Primary	6 Minute Walk Distance (6MWD):	total distance in feet completed during test	6 minutes
Primary	6MWT power	total distance in feet multiplied by bodyweight in pounds	6 minutes
Secondary	Heart rate	beats per minute	1 minute
Secondary	Oxygen saturation	percentage via pulse oximetry	1-6 minutes
Secondary	Respiratory rate	breaths per minute	1-6 min
Secondary	Rating of perceived exertion	rating via Borg scale for perceived exertion: 0-10 with 0 being no breathlessness and 10 being maximal breathlessness	6 minutes