Clinical trial NCT05040893: A Pilot Study of a PhysiOthErapy-based Tailored Intervention for Long COVID (COVID-19)
Official title: A Pilot Feasibility Study of a Physiotherapy-based Tailored Intervention for Long COVID.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Keywords: Long COVID
Physiotherapy
COVID-19
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Alberta Health services
First posted: 2021-09-10
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single-arm, open-label pilot study investigating the feasibility of the POETIC intervention. POETIC will test a patient-oriented, outpatient physiotherapy intervention tailored to each patient based on their symptoms, functional limitations, and goals.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility (patient recruitment and retention rate)
timeFrame: 120 days
Secondary outcomes:
measure: Quality of life (QOL)
timeFrame: 120 days
measure: Self-reported functional status
timeFrame: 120 days
measure: Self-efficacy for symptom management
timeFrame: 120 days
measure: Six-minute walk test
timeFrame: 120 days
measure: One-minute sit-to-stand test
timeFrame: 120 days
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Peter Lougheed Centre (PLC), University of Calgary
state: Alberta
city: Calgary
country: Canada
facility: Rockyview General Hospital, University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Jason Weatherald, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: