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

Role of Incentive Spirometry in pulmonary rehabilitation of severe COVID-19 patients- an open label randomised controlled trial - RISE COVID

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/08/035736
Enrollment
75
Registered
2021-08-17
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Interventions

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 outlin

Sponsors

Dr Animesh Ray
Lead Sponsor

Eligibility

Inclusion criteria

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 e) Decreasing supplemental oxygen requirements (Nasal prongs 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

Exclusion criteria

Exclusion criteria: a) MMSE b) Recent surgery, cardiovascular event (ACS, PE) c) Moderate-severe heart disease (NYHA grade III or IV) d) CLD with ascites e) Prior history of TB, COPD, asthma, ILD f) Pregnant and lactating women g) Difficulty in mobilisation (for 6MWT) h) Hemodynamically unstable i) Refusal of consent

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

India

Contacts

Public ContactDr Ayush Agarwal

All India Institute of Medical Sciences, New Delhi

doctoranimeshray@gmail.com01126593963

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026