Pulmonary Rehabilitation Post-COVID-19

NCT05003271 | Completed

• 1 other identifier: HS25183(B2021:101)
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this pilot study was to evaluate the feasibility, safety, and satisfaction of a remote interdisciplinary PR program delivered using two exercise approaches (video conference and self-directed) on the recovery of long-term post-COVD-19 outcomes. The specific aims were i) to evaluate the effect of each of the approaches on patients': 1) lung capacity, 2) dyspnea and fatigue, 3) exercise capacity, 4) physical function, 5) participation, and 5) HRQoL.

Conditions

COVID-19

Keywords

Long COVID-19; Persistent respiratory symptoms

Outcome Measures

Primary Outcomes (6)

• Feasibility of the program

  This was determined according to the following criteria: (1) 70% of participants completed the PR program, (2) data on primary outcomes collected in ≥ 70% of participants after the PR program, and (3) \< 10% of adverse events related to the intervention.

  8 weeks (end of the study)

• Recruitment rate

  Calculated as percentage of potentially eligible participants that were recruited.

  8 weeks (beginning of the study)

• Intervention completion rate

  Calculated as the percentage of sessions attended by participants. The number of sessions in the vide conference group was recorded by the therapist who attended Zoom meeting, whereas those in the self-directed group were asked to record the number of sessions in the diary.

  8 weeks

• Dropout rate

  Calculated as the proportion of individuals who ceased participation after randomization and before completing 80% of sessions due to adverse events or personal preferences.

  8 weeks

• Patient safety

  Represented as the incidence of adverse events caused by the interventions.

  8 weeks

• Patient satisfaction with the program

  Participants will complete a short summary with questions regarding their satisfaction with the study

  after 8 weeks (end of the study)

Secondary Outcomes (9)

• Change in lung capacity

  8 weeks

• Change in dyspnea

  8 weeks

• Changes in fatigue severity assessed with the Fatigue Severity Scale

  8 weeks

• Changes in fatigue assesses with the DePaul Symptom Questionnaire short-form

  8 weeks

• Change in sit-to-stand capacity

  8 weeks

Study Arms (2)

Small group zoom meeting

EXPERIMENTAL

Group one: participants were asked to follow the exercise program with a small group of peers (2 groups/6 participants each) in a Zoom meeting 3 times a week/45 min each (including 5 min before and 10 min after the meeting for free talk-chat between the participants; e.g., questions, perceptions, etc.).

Other: Exercise program (virtual/remote)

YouTube pre-recorded video

EXPERIMENTAL

Group two: participants were asked to follow the exercise program 3 times a week/30 min each while watching a pre-recorded YouTube video.

Other: Exercise program (virtual/remote)

Interventions

Exercise program (virtual/remote) OTHER

Intervention (8 weeks): using the participants' initial assessment and personal characteristics, the therapist will provide personalized recommendations (e.g. maximum heart rate, minimum SpO2), explain the educational materials, and instruct patients on safety precautions.

Small group zoom meeting; YouTube pre-recorded video

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Post-COVID-19 ≥ 3 months after infection.
• Mild to severe persistent respiratory symptoms
• Access to a smart phone, tablet or computer, and home internet

You may not qualify if:

• History of neurological disease or mental illness
• Inability to ambulate independently without supervision
• Inability to complete basic tasks on a smart phone or tablet
• Did not return calls after the initial contact

Sponsors & Collaborators

• University of Manitoba: lead
• Health Sciences Centre Foundation, Manitoba: collaborator
• Health Sciences Centre, Winnipeg, Manitoba: collaborator

Study Sites (1)

U of Manitoba

Winnipeg, Manitoba, R3E 0T6, Canada

Location

Related Publications (1)

• Sarmento A, Adodo R, Hodges G, Webber SC, Sanchez-Ramirez DC. Virtual pulmonary rehabilitation approaches in patients with post COVID syndrome: a pilot study. BMC Pulm Med. 2024 Mar 18;24(1):139. doi: 10.1186/s12890-024-02965-3.

  PMID: 38500051 DERIVED

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Diana C Sanchez-Ramirez, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: Two groups pre-post assessment (pilot/feasibility study)

Study Record Dates

• First Submitted: August 6, 2021
• First Posted: August 12, 2021
• Study Start: April 4, 2022
• Primary Completion: August 30, 2022
• Study Completion: October 1, 2023
• Last Updated: January 3, 2024

Record last verified: 2023-12

Locations

CA (1)