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Standardization of the 6-min walk test in clinical trials of idiopathic pulmonary fibrosis
- Source :
- Contemporary clinical trials. 100
- Publication Year :
- 2020
-
Abstract
- The 6-min walk test (6MWT) is an important measure of functional capacity in idiopathic pulmonary fibrosis (IPF) and has been an endpoint of several IPF clinical trials. However, current guidance for the 6MWT offers insufficient advice on standardization, particularly oxygen supplementation, for clinical trials. Three physicians experienced with the 6MWT and IPF developed a standardized protocol for the 6MWT based on existing clinical guidelines and published literature. The protocol comprises guidance on test conditions, pre-defined parameters to measure at specified timepoints, and step-by-step instructions on conducting the test. The standardized test will be evaluated in the large-scale phase 3 ISABELA trials ( NCT03711162 ; NCT03733444 ). The test is conducted indoors, using standardized equipment, along a flat, straight, 30-m unobstructed corridor; tests for each individual are performed by the same administrators at the same time of day; warm-up prior to testing is prohibited; supplemental oxygen tanks are permitted and moved by the patient in the same manner for each test; precise wording is used to instruct and encourage patients. Contraindications and stopping criteria are specified. Key assessments include: 6-min walk distance, distance walked at 1 and 3 min, the Borg CR10 scale, heart rate, blood pressure, and oxygen desaturation levels. A standardized 6MWT for IPF will enable more reliable comparisons between clinical trials and limit variability, optimizing use as an endpoint. Application of the standardized 6MWT in the ISABELA program will allow its correlation with other clinically important endpoints and may lead to novel composite endpoints for use in future trials. Submission category: Study Design, Statistical Design, Study Protocols. Submission classifications: Clinical study methodology; Clinical trial design; Clinical trials; Pulmonary disease; Pulmonary disease clinical trial; Respiratory medicine.
- Subjects :
- medicine.medical_specialty
Standardized test
Walk Test
Walking
03 medical and health sciences
Idiopathic pulmonary fibrosis
0302 clinical medicine
Heart Rate
medicine
Humans
Pharmacology (medical)
030212 general & internal medicine
Protocol (science)
Clinical Trials as Topic
030505 public health
business.industry
Clinical study design
Interstitial lung disease
General Medicine
Reference Standards
medicine.disease
Idiopathic Pulmonary Fibrosis
Test (assessment)
Clinical trial
Blood pressure
Physical therapy
Exercise Test
0305 other medical science
business
Subjects
Details
- ISSN :
- 15592030
- Volume :
- 100
- Database :
- OpenAIRE
- Journal :
- Contemporary clinical trials
- Accession number :
- edsair.doi.dedup.....afd889c4e76431db13f016293537f637