Back to resultsA Pilot Study of a PhysiOthErapy-based Tailored Intervention for Long COVID (COVID-19) (POETIC)
Primary Purpose
COVID-19
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring Long COVID, Physiotherapy, COVID-19
Eligibility Criteria
Inclusion Criteria:
- Participant has English language fluency (approximately grade 8-10 reading level) and is able to provide informed consent.
- Participant is an adult (aged ≥ 18 years).
- Confirmed diagnosis of COVID-19 via a positive nasopharyngeal or throat swab within the past 12 months.
- 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).
- Normal oxygen saturation (greater than 90%) by pulse oximetry at rest on room air.
- 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:
- Abnormal pulmonary function testing (FEV1/FVC ratio <70, total lung capacity <80% predicted, or diffusing capacity <70% predicted).
- Pre-existing diagnosis chronic lung disease (Interstitial lung disease, COPD, bronchiectasis, or moderate to severe asthma).
- Pulmonary embolism.
- Parenchymal abnormalities on chest radiograph, deemed clinically significant by the pulmonologist.
- Acute or chronic cardiac disease by medical history (myocardial infarction, myocarditis, cardiomyopathy, arrhythmia, moderate or severe valve disease, ventricular dysfunction).
- Syncope at rest or exertion (which could indicate clinically significant cardiac disease).
- Pre-existing diagnosis of a post-viral fatigue syndrome, myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) or fibromyalgia.
Sites / Locations
- Peter Lougheed Centre (PLC), University of Calgary
- Rockyview General Hospital, University of Calgary
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Outpatient Physiotherapy Intervention
Arm Description
POETIC will test a patient-oriented, outpatient physiotherapy intervention tailored to each patient based on their symptoms, functional limitations, and goals. The intervention consists of eight one-on-one, supervised sessions delivered over 8 to 10 weeks, approximately one week apart. Each session will be approximately one hour long.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Six-minute walk test
The distance a patient can walk during six minutes.
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.
Full Information
NCT ID
NCT05040893
First Posted
September 8, 2021
Last Updated
August 25, 2023
Sponsor
University of Calgary
Collaborators
Alberta Health services
1. Study Identification
Unique Protocol Identification Number
NCT05040893
Brief Title
A Pilot Study of a PhysiOthErapy-based Tailored Intervention for Long COVID (COVID-19)
Acronym
POETIC
Official Title
A Pilot Feasibility Study of a Physiotherapy-based Tailored Intervention for Long COVID.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 4, 2022 (Actual)
Primary Completion Date
August 9, 2023 (Actual)
Study Completion Date
November 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Calgary
Collaborators
Alberta Health services
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Long COVID, Physiotherapy, COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Outpatient Physiotherapy Intervention
Arm Type
Experimental
Arm Description
POETIC will test a patient-oriented, outpatient physiotherapy intervention tailored to each patient based on their symptoms, functional limitations, and goals. The intervention consists of eight one-on-one, supervised sessions delivered over 8 to 10 weeks, approximately one week apart. Each session will be approximately one hour long.
Intervention Type
Behavioral
Intervention Name(s)
Physiotherapy
Intervention Description
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).
Primary Outcome Measure Information:
Title
Feasibility (patient recruitment and retention rate)
Description
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.
Time Frame
120 days
Secondary Outcome Measure Information:
Title
Quality of life (QOL)
Description
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.
Time Frame
120 days
Title
Self-reported functional status
Description
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.
Time Frame
120 days
Title
Self-efficacy for symptom management
Description
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.
Time Frame
120 days
Title
Six-minute walk test
Description
The distance a patient can walk during six minutes.
Time Frame
120 days
Title
One-minute sit-to-stand test
Description
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.
Time Frame
120 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participant has English language fluency (approximately grade 8-10 reading level) and is able to provide informed consent.
Participant is an adult (aged ≥ 18 years).
Confirmed diagnosis of COVID-19 via a positive nasopharyngeal or throat swab within the past 12 months.
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).
Normal oxygen saturation (greater than 90%) by pulse oximetry at rest on room air.
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:
Abnormal pulmonary function testing (FEV1/FVC ratio <70, total lung capacity <80% predicted, or diffusing capacity <70% predicted).
Pre-existing diagnosis chronic lung disease (Interstitial lung disease, COPD, bronchiectasis, or moderate to severe asthma).
Pulmonary embolism.
Parenchymal abnormalities on chest radiograph, deemed clinically significant by the pulmonologist.
Acute or chronic cardiac disease by medical history (myocardial infarction, myocarditis, cardiomyopathy, arrhythmia, moderate or severe valve disease, ventricular dysfunction).
Syncope at rest or exertion (which could indicate clinically significant cardiac disease).
Pre-existing diagnosis of a post-viral fatigue syndrome, myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) or fibromyalgia.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Weatherald, MD, MSc
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peter Lougheed Centre (PLC), University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T1Y 6J4
Country
Canada
Facility Name
Rockyview General Hospital, University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2V 1P9
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study of a PhysiOthErapy-based Tailored Intervention for Long COVID (COVID-19)
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