Feasibility of a tailored Pulmonary Rehabilitation program to improve functional capability and reduce breathlessness among a cohort of Long COVID patients with respiratory symptoms in rural Tamil Nadu: an implementation trial.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Endurance shuttle walking test (ESWT) to measure exercise capacity.
研究概览
简要总结
The COVID-19 pandemic in 2020 has affected more than 775 million people and has resulted in more than 4 million deaths globally (1). A significant proportion of COVID-19 survivors have reporting persistent general fatigue, and on-going respiratory (dyspnea, cough, throat pain) and non-respiratory related symptoms [neurological symptoms (i.e., headaches, anosmia or ageusia), gastrointestinal symptoms (i.e., diarrhea or vomiting) or dermatological disorders (i.e., hair loss, skin rashes)] following COVID-19 infection (2). The literature on post-COVID symptoms is still in its early stages but post-COVID sequelae causes a considerable burden on the individual health, health systems and the economy worldwide (3). This study aims to identify the prevalence of persistent COVID-19 symptoms among a cohort of COVID-19 survivors after five years of infection and to test the feasibility of a tailored pulmonary rehabilitation program among those with Long COVID in a low-resource limited setting.
Objectives
1. To identify the prevalence of persistent COVID-19 symptoms among a cohort of COVID-19 survivors after five years of SARS-CoV-2 infection in two rural blocks of Tamil Nadu.
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To systematically review the literature to identify the effective components, and delivery of pulmonary rehabilitation for Long COVID patients in low-resource settings.
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To develop, with stakeholders, a tailored pulmonary rehabilitation intervention for people with persistent symptoms due to Long COVID.
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To test the feasibility of tailored pulmonary rehabilitation among Long COVID patients affected by post-COVID-19 respiratory symptoms in a low resource rural setting.
The prevalence of persistent COVID-19 symptoms among a cohort of COVID-19 survivors after five years of SARS-CoV-2 infection will be identified through a cross-sectional survey using standardized questionnaires in K.V. Kuppam and Gudiyatham block. List of COVID-19 positive patients (above 18 years of age) in K.V.Kuppam and Gudiyatham block during the first and second wave will be obtained from Vellore district health office (after prior permission from the Directorate of Public Health & Preventive Medicine, Chennai, Tamil Nadu). A complete line listing of the positive patients from March 2020 to June 2021 will be prepared and with the help of field workers participants will be identified by the PhD Student (researcher).
The researcher will contact the study participants and provide the information of the study. Participants willing to provide consent will be screened using the study tools and cardiorespiratory parameters in their homes. The process for diagnosing Long COVID will be done based on the evaluation of symptoms, time points of symptoms appearance and exclusion of other conditions through the Post COVID-19 symptoms checklist. And those identified with one or more persisting COVID-19 symptoms at the time of the survey will be referred to the nearby secondary care hospital for further diagnosis and treatment. The prevalence of Long COVID will be estimated in percentage and a timeline of symptoms will be recorded during the interview and plotted on a graph.
Long COVID participants with respiratory symptoms from the cross-sectional survey will be referred to secondary care hospital where the physician will complete a diagnose and refer for further investigations such as spirometry (inspiratory and expiratory lung volumes), blood tests and chest x-ray as a part of standard clinical examination. Eligible participants will be referred to the researcher for providing information on the study and to obtain consent. Following consent, the participants will be complete the baseline measurement. A two - arm, single site, individually randomised pragmatic clinical trial will be conducted to evaluate Long COVID tailored Pulmonary Rehabilitation (Long COVID-T-PR) compared to a usual care (UC) for Long COVID patients with respiratory symptoms in low-resource settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)(—)
- 性别
- All
入选标准
- •Participants from the prevalence study with confirmed respiratory symptoms with or without respiratory structural and functional abnormality.
- •Participants with FEV1/FVC less than 0.7 in post bronchospirometry.
- •Participants with modified Medical Research Council Dyspnoea Scale (mMRC) greater than or equal to 2
- •Participants with checklist Individual Strength (CIS)-fatigue greater than or equal to 36
- •Participants with post-COVID-19 Functional Status (PCFS) greater than or equal to 2.
排除标准
- •If they have a known or self-reported cognitive, hearing, visual, neurological or musculoskeletal conditions that preclude participation in PR.
- •Any diagnosis of angina pectoris, recent myocardial infarction, severe pulmonary hypertension, congestive heart failure, unstable diabetes.
- •Inability to do exercise due to orthopaedic or other reasons.
- •Psychiatric illness.
- •Severe exercise-induced hypoxemia, not correctable with O2 supplementation
- •Unwilling to give consent.
结局指标
主要结局
Endurance shuttle walking test (ESWT) to measure exercise capacity.
时间窗: 0 - Baseline | 10 - 12 weeks - Endline
次要结局
- 1. St Georges Respiratory Questionnaire (SGRQ)(2. MRC Dyspnoea Scale (mMRC))
研究者
Paul Jebaraj
Christian Medical College, Vellore
