Spirometry in rehabilitation of severe COVID-19 patients- a randomised controlled trial

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2021
INTERVENTION: Intervention1: Volume oriented spirometer: Through the volume oriented spirometer, patients will be instructed to inspire slowly and deeply till the yellow indicator on the piston reaches blue outlined area and then hold breath for as long as possible and then exhale slowly. The participants will do 3 sessions per day with 2 repetitions in each session. Each repetition consists of 10 breaths followed by brief rest of normal breathing for 1 minute. This will be continued for 1 month post discharge. Intervention2: Flow oriented spirometer: Using flow oriented spirometer, patients will be instructed to inspire slowly and deeply till the lifting of atleast 2 balls and then hold breath for as long as possible and then exhale slowly. The participants will do 3 sessions per day with 2 repetitions in each session. Each repetition consists of 10 breaths followed by brief rest of normal breathing for 1 minute This will be continued for 1 month post discharge. Control Intervention1: Deep breathing exercise using Anulom Vilom: In it, participants will inhale slowly through right nostril closing the left nostril, exhale fully through the left one closing the other one, repeat this in cyclic manner. The mouth shall remain closed. The participants will do 3 sessions per day with 2 repetitions in each session. Each repetition consists of 10 breaths followed by brief rest of normal breathing for 1 minute. This will be continued for 1 month post discharge. CONDITION: Health Condition 1: B972‐ Coronavirus as the cause of diseases classified elsewhere PRIMARY OUTCOME: Degree of improvement in respiratory parameters as measured by S. George Respiratory questionnaire (SGRQ), 6 minute walk test (6MWT), mMRC dyspnea scale and single breath count.Timepoint: At discharge, 2 weeks, 1 month and 3 months SECONDARY OUTCOME: Degree of improvement in quality of life: EQ5D5LTimepoint: At discharge, 2 weeks, 1 month and 3 months Percentage of patients attaining SpO2 â?¥92% at different time points of follow upTimepoint: At discharge, 2 weeks, 1 month and 3 months INCLUSION CRITERIA: a) Aged at least 18 years b) Hospitalised c) Confirmed SARS‐CoV‐2 infection by nucleic acid based testing (RT‐PCR, CB‐NAAT, or TrueNAT) or antigen testing d) Moderate and severe COVID‐19 pneumonia (SpO2 <94%) e) Decreasing supplemental oxygen requirements (Nasal prongs â?¤6 L/min) f) Hemodynamically stable g) Cooperative h) No medical history that might, in the opinion of the attending clinician, put the patient at significant risk if he/she were to participate in the trial
Epistemonikos ID: 355a217c31debbb3cf92a1e32ec4c3a03775c575
First added on: Aug 25, 2024