COVID-19POETICNCT05040893
A Pilot Study of a PhysiOthErapy-based Tailored Intervention for Long COVID (COVID-19)
A study testing Physiotherapy in people with COVID-19, run by University of Calgary at 2 sites in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Physiotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesCanada
- Study dates
- 4 Mar 2022to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Peter Lougheed Centre (PLC), University of Calgary
Calgary, Alberta, T1Y 6J4
Rockyview General Hospital, University of Calgary
Calgary, Alberta, T2V 1P9
About this study
Official title: A Pilot Feasibility Study of a Physiotherapy-based Tailored Intervention for Long COVID.
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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- Physiotherapy
- Keywords
- Long COVID, Physiotherapy, COVID-19
- Medical subject headings
- COVID-19, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Outpatient Physiotherapy Intervention | Experimental | 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. Receives: Behavioral: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 120 days
Secondary outcomes (5)
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.
Measured: 120 days
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.
Measured: 120 days
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.
Measured: 120 days
Six-minute walk test
The distance a patient can walk during six minutes.
Measured: 120 days
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.
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start4 Mar 2022
- Primary completion9 Aug 2023
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Health services
- Responsible party
- Sponsor
- Investigators
- Jason Weatherald, MD, MSc, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05040893
- Sponsor's protocol ID
- REB21-0767
- Acronym
- POETIC
- Status last verified
- Nov 2022
- First submitted
- 8 Sep 2021
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lo M, Eiriksson L, Hunter S, Twomey R, Skolnik K, Chen J, Afshar EE, Weatherald J, Lim RK. Individually Tailored Physiotherapy in Persons With Respiratory Symptoms Related to Post-Acute Sequelae of COVID-19: A Feasibility Study With Mixed Methods. Health Sci Rep. 2025 Oct 21;8(10):e71367. doi: 10.1002/hsr2.71367. eCollection 2025 Oct.
PubMed 41132192
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Feasibility Study of a Physiotherapy-based Tailored Intervention for Long COVID.
- ClinicalTrials.gov ID
- NCT05040893
- Acronym / sponsor ID
- POETIC / REB21-0767
- Conditions
- COVID-19
- Keywords
- Long COVID, Physiotherapy, COVID-19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Alberta Health services
- Study start
- 4 Mar 2022 (actual)
- Primary completion
- 9 Aug 2023 (actual)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 10 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Outpatient Physiotherapy Intervention | Experimental | Behavioral: PhysiotherapyPOETIC 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhysiotherapyInterventions will include: 1. Education and self-management strategies, including the use of wearable activity and real-time heart rate monitors, to safely guide pacing and activity. 2. Breathing pattern education and retraining (including diaphragmatic, relaxed, and paced breathing exercises). 3. Return-to-activity exercise programming (e.g., postural, aerobic, and whole-body strengthening exercises). | Behavioural | Outpatient Physiotherapy Intervention |
Primary outcome
Feasibility (patient recruitment and retention rate)
Time frame: 120 days
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.
5 secondary outcomes
Quality of life (QOL)
Time frame: 120 days
Self-reported functional status
Time frame: 120 days
Self-efficacy for symptom management
Time frame: 120 days
Six-minute walk test
Time frame: 120 days
One-minute sit-to-stand test
Time frame: 120 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Derived from this study: PubMed 41132192Lo M, Eiriksson L, Hunter S, Twomey R, Skolnik K, Chen J, Afshar EE, Weatherald J, Lim RK. Individually Tailored Physiotherapy in Persons With Respiratory Symptoms Related to Post-Acute Sequelae of COVID-19: A Feasibility Study With Mixed Methods. Health Sci Rep. 2025 Oct 21;8(10):e71367. doi: 10.1002/hsr2.71367. eCollection 2025 Oct.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Weatherald, MD, MSc principal investigator
University of Calgary
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy in people with COVID-19, run by University of Calgary at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (patient recruitment and retention rate) (time frame: 120 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05040893, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2023.