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

NCT04058548 | Completed

• 1 other identifier: IRB-P00031139
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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).

Conditions

Cystic Fibrosis

Keywords

cystic fibrosis; walk test

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Heart rate

  1 minute

• Oxygen saturation

  1-6 minutes

• Respiratory rate

  1-6 min

• Rating of perceived exertion

  6 minutes

Study Arms (1)

6MWT and STS

EXPERIMENTAL

All participates will receive 6MWT and STS test

Diagnostic Test: Sit to stand test

Interventions

Sit to stand test DIAGNOSTIC_TEST

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

Also known as: 6 minute walk test

6MWT and STS

Eligibility Criteria

• Age: 6 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• patients age 6-35 with cystic fibrosis who are admitted for a pulmonary exacerbation and receive ongoing physical therapy throughout their admission.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (5)

• 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.

  PMID: 29605218 BACKGROUND

• 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.

  PMID: 27899540 BACKGROUND

• 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.

  PMID: 26363563 BACKGROUND

• 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.

  PMID: 28049743 BACKGROUND

• 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.

  PMID: 27799759 BACKGROUND

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Walk Test

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Exercise Test; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Jenna Gondelman

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist 2

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: August 15, 2019
• Study Start: September 5, 2019
• Primary Completion: May 12, 2021
• Study Completion: May 12, 2021
• Last Updated: July 16, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)