A Pilot Study of a PhysiOthErapy-based Tailored Intervention for Long COVID (COVID-19)

COVID-19 Clinical Trial

— POETIC  

Official title:

A Pilot Feasibility Study of a Physiotherapy-based Tailored Intervention for Long COVID.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05040893
• Other study ID #: REB21-0767
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 4, 2022
• Est. completion date: November 30, 2023

Study information

• Verified date: November 2022
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the benefits and feasibility of physiotherapy in the recovery of ongoing symptoms after COVID-19 illness. Long COVID Syndrome (Long COVID) is defined by persistent symptoms (including breathlessness, chest pain and fatigue) after COVID-19 illness that continue for more than 12 weeks and cannot be explained by another diagnosis. The goal of this project is to explore physiotherapy as treatment for patients suffering from Long COVID.

Description:

The global pandemic caused by Severe Acute Respiratory Syndrome Coronavirus 2 [COVID-19] has resulted in catastrophic loss of life and significant morbidity in survivors. It is now recognized that a significant number of patients have symptoms lasting for weeks to months after initial infection, a clinical entity termed "Long COVID". For many patients, this has led to an unexpectedly long recovery and has negatively impacted health-related quality of life (QOL). Persisting breathlessness, fatigue and exercise limitation were among the most common patient-reported symptoms after COVID-19 infection, affecting approximately 50% of individuals. Given the heterogeneity in the causes of breathlessness post-COVID, there are no specific medications that can be broadly recommended to alleviate dyspnea among these patients. Breathing retraining, combined with supervised exercise, improves QOL and exercise capacity among patients with various chronic lung diseases and is an important potential strategy that could reduce dyspnea and regain physical function among those with Long COVID. The benefits of physiotherapy are recognized in hospitalized, and critically ill patients, and physiotherapy interventions have been studied among hospitalized patients with acute COVID-19 pneumonia. Physiotherapy may also play an instrumental role in the recovery of ambulatory patients with Long COVID, but few data currently exist.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: November 30, 2023
• Est. primary completion date: August 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Participant has English language fluency (approximately grade 8-10 reading level) and is able to provide informed consent.

2. Participant is an adult (aged = 18 years).

3. Confirmed diagnosis of COVID-19 via a positive nasopharyngeal or throat swab within the past 12 months.

4. Persistent symptoms lasting =12 weeks since the first positive test, including dyspnea (new or increased from baseline as measured by modified Medical Research Council (mMRC) score =1).

5. Normal oxygen saturation (greater than 90%) by pulse oximetry at rest on room air.

6. Participant owns a smart phone, tablet, or computer, and has or is willing to create an email address (for links to REDCap and Zoom).

Exclusion Criteria:

1. Abnormal pulmonary function testing (FEV1/FVC ratio <70, total lung capacity <80% predicted, or diffusing capacity <70% predicted).

2. Pre-existing diagnosis chronic lung disease (Interstitial lung disease, COPD, bronchiectasis, or moderate to severe asthma).

3. Pulmonary embolism.

4. Parenchymal abnormalities on chest radiograph, deemed clinically significant by the pulmonologist.

5. Acute or chronic cardiac disease by medical history (myocardial infarction, myocarditis, cardiomyopathy, arrhythmia, moderate or severe valve disease, ventricular dysfunction).

6. Syncope at rest or exertion (which could indicate clinically significant cardiac disease).

7. Pre-existing diagnosis of a post-viral fatigue syndrome, myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) or fibromyalgia.

Related Conditions & MeSH terms

• COVID-19

Intervention

Behavioral:
• Physiotherapy
Interventions will include: Education and self-management strategies, including the use of wearable activity and real-time heart rate monitors, to safely guide pacing and activity. Breathing pattern education and retraining (including diaphragmatic, relaxed, and paced breathing exercises). Return-to-activity exercise programming (e.g., postural, aerobic, and whole-body strengthening exercises).

Locations

Country	Name	City	State
Canada	Peter Lougheed Centre (PLC), University of Calgary	Calgary	Alberta
Canada	Rockyview General Hospital, University of Calgary	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	Alberta Health services

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility (patient recruitment and retention rate)	Feasibility will be determined by recruitment of 12 participants within 3 months, retention of >70% of participants and mean completion of >70% of all supervised physiotherapy sessions.	120 days
Secondary	Quality of life (QOL)	The EuroQol-visual analogue scale (EQ-VAS) will be used to measure QOL. The EQ-VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine and 'The worst health you can imagine. The EQ-VAS is the main patient-reported outcome of interest and has an MCID of 8. In addition, the EQ-5D-5L ( 5-level EuroQol-5D)will be used to measure QOL across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Respondents select the level which most closely matches their health state (no problems, slight problems, moderate problems, severe problems or extreme problems). The choices made within each domain relate to a 1-digit number. Combining these digits results in a 5-digit number, which will be converted into a utility weight.	120 days
Secondary	Self-reported functional status	The Post-COVID Functional Scale (PCFS) will be used to measure participant self-reported functional impairment. It covers the full spectrum of functional outcomes, and focuses on limitations in usual activities in five scale grades (0 - 4). Grade 0 reflects the absence of any functional limitation, and upward of grade 1, symptoms, pain or anxiety are present to an increasing degree. Grade 4 reflects severe functional limitations.	120 days
Secondary	Self-efficacy for symptom management	The PROMIS Self-efficacy for Managing Chronic Conditions item bank will be used to measure self-efficacy to manage symptoms and self-efficacy to manage daily activities in both cases, the 4-item short forms). Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with higher scores indicating greater severity of depression.	120 days
Secondary	Six-minute walk test	The distance a patient can walk during six minutes.	120 days
Secondary	One-minute sit-to-stand test	The participant will be asked to fully stand and sit back without using their arms and to perform as many repetitions as they safely can within one minute.	120 days