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

Not Applicable

Completed

• Conditions: Cystic Fibrosis

• Registration Number: NCT04058548
• Lead Sponsor: Boston Children's Hospital

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-14
• Study First Submitted QC: 2019-08-14
• Study First Posted: 2019-08-15
• Study Start: 2019-09-05
• Primary Completion: 2021-05-12
• Study Completion: 2021-05-12
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-15
• Last Update Posted: 2021-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Rating of perceived exertion	6 minutes	rating via Borg scale for perceived exertion: 0-10 with 0 being no breathlessness and 10 being maximal breathlessness
Oxygen saturation	1-6 minutes	percentage via pulse oximetry
Heart rate	1 minute	beats per minute
Respiratory rate	1-6 min	breaths per minute

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States