Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04058548
Other study ID # IRB-P00031139
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 5, 2019
Est. completion date May 12, 2021

Study information

Verified date July 2021
Source Boston Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date May 12, 2021
Est. primary completion date May 12, 2021
Accepts healthy volunteers No
Gender All
Age group 6 Years to 35 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Sit to stand test
Participants will complete a sit to stand test in addition to a 6 minute walk test

Locations

Country Name City State
United States Boston Children's Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (5)

Andrade Lima C, Dornelas de Andrade A, Campos SL, Brandão 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. Review. — View Citation

Gruet M, Peyré-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. Epub 2016 Nov 15. — View 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. — View 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. — View 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. eCollection 2016. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 1-minute STS repetitions: Number of STS completed 1 minute
Primary 1 minute STS power: number of STS completed in 1 minute multiplied by bodyweight in pounds 1 minute
Primary 6 Minute Walk Distance (6MWD): total distance in feet completed during test 6 minutes
Primary 6MWT power total distance in feet multiplied by bodyweight in pounds 6 minutes
Secondary Heart rate beats per minute 1 minute
Secondary Oxygen saturation percentage via pulse oximetry 1-6 minutes
Secondary Respiratory rate breaths per minute 1-6 min
Secondary Rating of perceived exertion rating via Borg scale for perceived exertion: 0-10 with 0 being no breathlessness and 10 being maximal breathlessness 6 minutes
See also
  Status Clinical Trial Phase
Completed NCT04696198 - Thoracic Mobility in Cystic Fibrosis Care N/A
Completed NCT00803205 - Study of Ataluren (PTC124™) in Cystic Fibrosis Phase 3
Terminated NCT04921332 - Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD N/A
Completed NCT03601637 - Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Participants 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del Phase 3
Terminated NCT02769637 - Effect of Acid Blockade on Microbiota and Inflammation in Cystic Fibrosis (CF)
Recruiting NCT06012084 - The Development and Evaluation of iCF-PWR for Healthy Siblings of Individuals With Cystic Fibrosis N/A
Recruiting NCT06032273 - Lung Transplant READY CF 2: CARING CF Ancillary RCT N/A
Recruiting NCT06030206 - Lung Transplant READY CF 2: A Multi-site RCT N/A
Recruiting NCT06088485 - The Effect of Bone Mineral Density in Patients With Adult Cystic Fibrosis
Recruiting NCT05392855 - Symptom Based Performance of Airway Clearance After Starting Highly Effective Modulators for Cystic Fibrosis (SPACE-CF) N/A
Recruiting NCT04039087 - Sildenafil Exercise: Role of PDE5 Inhibition Phase 2/Phase 3
Recruiting NCT04056702 - Impact of Triple Combination CFTR Therapy on Sinus Disease.
Completed NCT04038710 - Clinical Outcomes of Triple Combination Therapy in Severe Cystic Fibrosis Disease.
Completed NCT03637504 - Feasibility of a Mobile Medication Plan Application in CF Patient Care N/A
Recruiting NCT03506061 - Trikafta in Cystic Fibrosis Patients Phase 2
Completed NCT03566550 - Gut Imaging for Function & Transit in Cystic Fibrosis Study 1
Recruiting NCT04828382 - Prospective Study of Pregnancy in Women With Cystic Fibrosis
Completed NCT04568980 - Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis
Recruiting NCT04010253 - Impact of Bronchial Drainage Technique by the Medical Device Simeox® on Respiratory Function and Symptoms in Adult Patients With Cystic Fibrosis N/A
Completed NCT02449785 - Assessment of Cystic Fibrosis Lung Involvement With UTE Pulse Sequences N/A