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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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ClinicalTrials.gov Identifier: NCT04058548
Recruitment Status : Not yet recruiting
First Posted : August 15, 2019
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
Jenna Gondelman, 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).

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Diagnostic Test: Sit to stand test Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

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 Name: 6 minute walk test




Primary Outcome Measures :
  1. 1-minute STS repetitions: [ Time Frame: 1 minute ]
    Number of STS completed

  2. 1 minute STS power: [ Time Frame: 1 minute ]
    number of STS completed in 1 minute multiplied by bodyweight in pounds

  3. 6 Minute Walk Distance (6MWD): [ Time Frame: 6 minutes ]
    total distance in feet completed during test

  4. 6MWT power [ Time Frame: 6 minutes ]
    total distance in feet multiplied by bodyweight in pounds


Secondary Outcome Measures :
  1. Heart rate [ Time Frame: 1 minute ]
    beats per minute

  2. Oxygen saturation [ Time Frame: 1-6 minutes ]
    percentage via pulse oximetry

  3. Respiratory rate [ Time Frame: 1-6 min ]
    breaths per minute

  4. Rating of perceived exertion [ Time Frame: 6 minutes ]
    rating via Borg scale for perceived exertion: 0-10 with 0 being no breathlessness and 10 being maximal breathlessness



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Ages Eligible for Study:   6 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04058548


Contacts
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Contact: Jenna Gondelman 617-355-7212 jenna.gondelman@childrens.harvard.edu

Sponsors and Collaborators
Boston Children’s Hospital
Investigators
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Principal Investigator: Jenna Gondelman Boston Children’s Hospital

Publications:
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Responsible Party: Jenna Gondelman, Physical Therapist 2, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT04058548     History of Changes
Other Study ID Numbers: IRB-P00031139
First Posted: August 15, 2019    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jenna Gondelman, Boston Children’s Hospital:
cystic fibrosis
walk test
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases