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

NCT ID: NCT04058548

Last Updated: 2021-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-05

Study Completion Date

2021-05-12

Brief Summary

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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

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Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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6MWT and STS

All participates will receive 6MWT and STS test

Group Type EXPERIMENTAL

Sit to stand test

Intervention Type DIAGNOSTIC_TEST

Participants will complete a sit to stand test in addition to a 6 minute walk test

Interventions

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Sit to stand test

Participants will complete a sit to stand test in addition to a 6 minute walk test

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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6 minute walk test

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jenna Gondelman

Physical Therapist 2

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jenna Gondelman

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

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Boston Children's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 29605218 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27899540 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26363563 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28049743 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27799759 (View on PubMed)

Other Identifiers

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IRB-P00031139

Identifier Type: -

Identifier Source: org_study_id

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