Effect of Pulmonary Telerehabilitation and Telemonitoring for Patients With Chronic Respiratory Diseases

NCT05824910 | Completed

• 1 other identifier: HS25892 (B2023:030)
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is being conducted to evaluate the feasibility of using technology to deliver a remote home exercise program and assess the health outcomes of patients with chronic lung diseases. Specific objectives are to assess the interventions on patients: 1) Lung function, 2) Dyspnea, 3) Fatigue, 4) Exercise capacity, 5) Self-efficacy, and 6) Health-related quality of life. The investigators will also be evaluating the practicality of using videoconferencing and commercial wearable telemonitoring devices (ie. smart watches) for the implementation of the intervention in this group of patients.

Conditions

COPD; Interstitial Lung Disease

Keywords

chronic respiratory diseases; telemonitoring; telerehabilitation; pulmonary rehabilitation

Outcome Measures

Primary Outcomes (10)

• Change in Lung Function

  % predicted FEV1 and FVC will be assessed using a SpiroBank Smart F/V multi parameter spirometer (MIR) at pre-post intervention and once a week in between to monitor changes. This portable spirometer, which is MDSAP approved and complaint with ATS/ ERS guidelines, connects automatically via Bluetooth to an iOS \& Android compatible App (MIR Spirobank).

  8 weeks

• Change in Dyspnea

  Modified Borg Scale (0 "best" to 10 "worse") will be used to assess dyspnea.

  8 weeks

• Change in Fatigue

  Fatigue severity scale (0 -7 "higher worse") will be used to measure the severity of fatigue.

  8 weeks

• Change in Exercise Capacity

  Assessed with the one-minute sit-to-stand test (number of times the persons can complete the task in one minute).

  8 weeks

• Change in Self-efficacy

  Assessed using the Self-Efficacy for Managing Chronic Disease 6-Item Scale each rated from 0 "not at all confident" to 10 "totally confident")

  8 weeks

• Change in Health Relate quality of life

  Assessed with the Clinical COPD Questionnaire (Scored from 0 - 6 \[worse\])

  8 weeks

• Change in Dyspnea severity

  Assessed with the modified Medical Research Council (0-4 "higher is worse outcome").

  8 weeks

• Impact of cough on quality of life

  Assessed with the Leicester Cough Questionnaire (3 - 21 points). Lower scores indicate higher impact of cough on quality of life

  8 weeks

• Level of Dysphagia

  Assessed with the Sydney Swallow Questionnaire(0-100mm "higher represent worse outcome").

  8 weeks

• Change in Health Relate quality of life

  Assessed with the St. George's Respiratory Questionnaire. Total score is calculated from 0 (no health impairment) to 100 (maximum health impairment)

  8 weeks

Secondary Outcomes (1)

• Participant feedback questionnaire

  8 weeks

Study Arms (1)

Small group zoom meeting

EXPERIMENTAL

2 groups of 6 participants will be asked to follow the exercise program with their peers in a zoom meeting 3 times a week for 45 min each time. This time includes 5 min before and 10 min after for free talk and chat between participants. There will also be a weekly zoom education session for 30min.

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

Eligibility Criteria

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

You may qualify if:

• confirmed diagnosis of COPD or ILD
• living in Manitoba
• Access to smart phone or tablet and home internet service

You may not qualify if:

• acute exacerbation of their condition
• history of neurological disease or mental illness
• inability to ambulate independently without supervision
• inability to complete basic tasks on a smart phone or tablet

Sponsors & Collaborators

• University of Manitoba: lead
• Manitoba Medical Service Foundation: collaborator

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, R3E0T6, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; 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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: one group pre/post assessment (feasability study)

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: April 24, 2023
• Study Start: May 20, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 4, 2025

Record last verified: 2025-05

Locations

CA (1)