NCT05040893

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Mar 2022

Longer than P75 for not_applicable covid19

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 10, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

March 4, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 9, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

August 29, 2023

Status Verified

November 1, 2022

Enrollment Period

1.4 years

First QC Date

September 8, 2021

Last Update Submit

August 25, 2023

Conditions

Keywords

Long COVIDPhysiotherapyCOVID-19

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Quality of life (QOL)

    120 days

  • Self-reported functional status

    120 days

  • Self-efficacy for symptom management

    120 days

  • Six-minute walk test

    120 days

  • One-minute sit-to-stand test

    120 days

Study Arms (1)

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.

Behavioral: Physiotherapy

Interventions

PhysiotherapyBEHAVIORAL

Interventions 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).

Outpatient Physiotherapy Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Peter Lougheed Centre (PLC), University of Calgary

Calgary, Alberta, T1Y 6J4, Canada

Location

Rockyview General Hospital, University of Calgary

Calgary, Alberta, T2V 1P9, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

COVID-19Post-Acute COVID-19 Syndrome

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Jason Weatherald, MD, MSc

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2021

First Posted

September 10, 2021

Study Start

March 4, 2022

Primary Completion

August 9, 2023

Study Completion

November 30, 2023

Last Updated

August 29, 2023

Record last verified: 2022-11

Locations