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

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 Overview

• Status: Completed
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Diagnostic test: Sit to stand test

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 35 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 6MWT and STS; All participates will receive 6MWT and STS test	Diagnostic test: Sit to stand test; Participants will complete a sit to stand test in addition to a 6 minute walk test; Other Names: 6 minute walk test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1-minute STS repetitions:	Number of STS completed	1 minute
1 minute STS power:	number of STS completed in 1 minute multiplied by bodyweight in pounds	1 minute
6 Minute Walk Distance (6MWD):	total distance in feet completed during test	6 minutes
6MWT power	total distance in feet multiplied by bodyweight in pounds	6 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	beats per minute	1 minute
Oxygen saturation	percentage via pulse oximetry	1-6 minutes
Respiratory rate	breaths per minute	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	6 minutes

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Investigators: Principal Investigator: Jenna Gondelman, Boston Children's Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2019
• Primary Completion (Actual): May 12, 2021
• Study Completion (Actual): May 12, 2021

Study Registration Dates

• First Submitted: August 14, 2019
• First Submitted That Met QC Criteria: August 14, 2019
• First Posted (Actual): August 15, 2019

Study Record Updates

• Last Update Posted (Actual): July 16, 2021
• Last Update Submitted That Met QC Criteria: July 15, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: cystic fibrosis; walk test
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: IRB-P00031139

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No