Asthma
Conditions
Interventions
Individuals with chronic respiratory disease who are going to perform the six-minute walk test (6MWT) in the pulmonary physiology unit of the Hospital de Clinicas de Porto Alegre (HCPA) and accept to
D010092
Sponsors
Hospital de Clinicas de Porto Alegre (HCPA)
Universidade Federal do Rio Grande do Sul (UFRGS)
Eligibility
Inclusion criteria
Inclusion criteria: Individuals of both genders; over 18 years of age; with chronic respiratory disease; who have a request from the assistant physician to perform the six-minute walk test at the Pulmonary Physiology Unit of the Hospital de Clinicas de Porto Alegre (HCPA)
Exclusion criteria
Exclusion criteria: Individuals with contraindications for performing the six-minute walk test; those who performed at least one six-minute walk test in the 3 months prior to inclusion; which weather conditions that standard pulse oximetry signal in the resting measurement at the beginning of the six-minute walk test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the difference in the distance walked between the six-minute walk test (6MWT) with and without continuous monitoring of peripheral oxygen saturation (SpO2) in patients with chronic respiratory diseases, using the 6MWT method, which are not the requirements with respiratory disease chronic disease will be randomized to one of the protocols: A) WITH continuous monitoring of SpO2, or B) WITHOUT continuous monitoring of SpO2. In order to have the statistical power to detect a difference of 30 meter with standard deviation 90 meters between the tests performed with and without continuous SpO2 monitoring, it intends to include a minimum sample of 143 participants in each group. Anticipating possible losses and unsatisfactory collections, we planned the final inclusion of 300 participants. So we will observe if there is a difference in the distance covered in the 6MWT between the groups | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess the difference between respiratory rate (RR), heart rate (HR), peripheral oxygen saturation (SpO2), systemic blood pressure (SBP), dyspnea intensity and lower limb pain comparing the six-minute walk test with and without continuous monitoring of SpO2 in patients with chronic respiratory diseases, using the 6MWT method, which problems with respiratory disease will be randomized according to one of the procedures: A) WITH continuous monitoring of SpO2, or B) WITHOUT continuous monitoring of SpO2. In order to have the statistical power to detect a difference of 30 meter with standard deviation 90 meters between the tests performed with and without continuous SpO2 monitoring, it intends to include a minimum sample of 143 participants in each group. Anticipating possible losses and unsatisfactory collections, we planned the final inclusion of 300 participants. Thus, we will observe if there is a difference in RR, HR, SpO2, SBP, dyspnea and pain in the lower limbs between the groups;Comparison of the frequency and intensity of adverse events between the six-minute walk test performed with and without continuous SpO2 monitoring in patients with chronic respiratory diseases, using the 6MWT method, in which the disabled with respiratory disease will be randomized according to one of the Protocols : A) WITH continuous SpO2 monitoring, or B) WITHOUT continuous SpO2 monitoring. In order to have the statistical power to detect a difference of 30 meters with standard deviation 90 meter between the tests performed with and without continuous SpO2 monitoring, it intends to include a minimum sample of 143 participants in each group. Anticipating possible losses and unsatisfactory collections, we planned the final inclusion of 300 participants. As soon as we observe the frequency and intensity of adverse events between the six-minute walk test performed with and without continuous SpO2 monitoring | — |
Countries
Brazil
Contacts
Public ContactDanilo Berton
Outcome results
None listed