Pulmonary Rehabilitation Post-COVID-19

NCT ID: NCT05003271

Last Updated: 2024-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-04
• Study Completion Date: 2023-10-01

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.

Detailed Description

This pilot study used a two-arm randomized pre- and post-trial design 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 (≥ 3 months after infection). Group one (video conference): 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 and perceptions). The therapist organized and led the Zoom meetings to resolve general questions (e.g. equipment, platforms, etc.). Group two: participants were asked to follow the exercise program 3 times a week/30 min each while watching a pre-recorded video created by the research team and uploaded on YouTube. Patients were asked to wear the finger pulse oximeter at all times while exercising, so that they could control their pace while avoiding exceeding target values (HR and SpO2). They were also asked to record their HR and SpO2 values before and after participation in every session of the exercise program in a diary. All participants from both groups could contact the therapist at any time during the study if they had questions or concerns. They also received a follow-up phone call once a week from the therapist.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Small group zoom meeting

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.).

Group Type: EXPERIMENTAL

Exercise program (virtual/remote)

Intervention Type: 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.

YouTube pre-recorded video

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

Group Type: EXPERIMENTAL

Exercise program (virtual/remote)

Intervention Type: 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.

Interventions

Exercise program (virtual/remote)

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Health Sciences Centre Foundation, Manitoba

OTHER

Sponsor Role: collaborator

Health Sciences Centre, Winnipeg, Manitoba

OTHER

Sponsor Role: collaborator

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Diana C Sanchez-Ramirez, PhD

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Diana C Sanchez-Ramirez, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

U of Manitoba

Winnipeg, Manitoba, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 38500051 (View on PubMed)

Other Identifiers

HS25183(B2021:101)

Identifier Type: -

Identifier Source: org_study_id