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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

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sit to stand test
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cystic Fibrosis focused on measuring cystic fibrosis, walk test

Eligibility Criteria

6 Years - 35 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Boston Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

6MWT and STS

Arm Description

All participates will receive 6MWT and STS test

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 14, 2019
Last Updated
July 15, 2021
Sponsor
Boston Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04058548
Brief 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
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

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
September 5, 2019 (Actual)
Primary Completion Date
May 12, 2021 (Actual)
Study Completion Date
May 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
cystic fibrosis, walk test

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
6MWT and STS
Arm Type
Experimental
Arm Description
All participates will receive 6MWT and STS test
Intervention Type
Diagnostic Test
Intervention Name(s)
Sit to stand test
Other Intervention Name(s)
6 minute walk test
Intervention Description
Participants will complete a sit to stand test in addition to a 6 minute walk test
Primary Outcome Measure Information:
Title
1-minute STS repetitions:
Description
Number of STS completed
Time Frame
1 minute
Title
1 minute STS power:
Description
number of STS completed in 1 minute multiplied by bodyweight in pounds
Time Frame
1 minute
Title
6 Minute Walk Distance (6MWD):
Description
total distance in feet completed during test
Time Frame
6 minutes
Title
6MWT power
Description
total distance in feet multiplied by bodyweight in pounds
Time Frame
6 minutes
Secondary Outcome Measure Information:
Title
Heart rate
Description
beats per minute
Time Frame
1 minute
Title
Oxygen saturation
Description
percentage via pulse oximetry
Time Frame
1-6 minutes
Title
Respiratory rate
Description
breaths per minute
Time Frame
1-6 min
Title
Rating of perceived exertion
Description
rating via Borg scale for perceived exertion: 0-10 with 0 being no breathlessness and 10 being maximal breathlessness
Time Frame
6 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jenna Gondelman
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29605218
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.
Results Reference
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PubMed Identifier
27899540
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.
Results Reference
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PubMed Identifier
26363563
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.
Results Reference
background
PubMed Identifier
28049743
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.
Results Reference
background
PubMed Identifier
27799759
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.
Results Reference
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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

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