Assessing Functional Capacity in Directly and Remotely Monitored Home-based Settings: A Protocol for a Multinational Validation Study in Individuals With Chronic Respiratory Diseases

NCT06447831 | Recruiting

• 1 other identifier: 2024-4075, 22380
• Study Type: observational
• Target: 82
• Locations: 2 countries
• Sites: 3

Brief Summary

The goal of this validation study is to provide further evidence of the metrological properties of the 6-minute stepper test in individuals with chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD). The main questions it aims to answer are:

• Conduct the 6-minute stepper test (several trials on separate days)
• Conduct the 6-minute walk test (1 trial on 1 day)
• Conduct a maximal cardiopulmonary test on a cycle ergometer (1 trial on 1 day)
• Participate in a semi-structured interview to provide their feedback with regards to the 6-minute stepper test

Conditions

COPD Chronic Obstructive Pulmonary Disease; Interstitial Lung Disease

Keywords

Chronic Obstructive Pulmonary Disease; Exercise Capacity Test; Interstitial Lung Diseases; Physiotherapy; Rehabilitation; Telerehabilitation; Validation Study; Stepper Test

Outcome Measures

Primary Outcomes (4)

• Concurrent validity

  Assessed using paired sample t-tests (or Wilcoxon signed-rank tests) to verify whether peak cardiorespiratory (e.g., oxygen consumption, minute ventilation, heart rate, etc.) and symptomology (i.e., dyspnea and leg fatigue) values obtained during the 6-minute stepper test are comparable to the maximal cardiopulmonary test and the 6-minute walk test

  Study 1 - Two 3-hour laboratory visits (separated by 6 to 18 days)

• Strength of association between peak cardiorespiratory and symptomology values

  Pearson's correlation coefficients (r) will be calculated between the number of steps taken during the 6-minute stepper test and peak oxygen consumption and heart rate reached during all three tests

  Study 1 - Two 3-hour laboratory visits (separated by 6 to 18 days)

• Agreement

  Assessed with Bland-Altman plots and 95% limits of agreement (mean difference ± 1.96 standard deviation of the difference) between peak cardiorespiratory and symptomology values reached during the 6-minute stepper test and those reached during the maximal cardiopulmonary test and the 6-minute walk test

  Study 1 - Two 3-hour laboratory visits (separated by 6 to 18 days)

• Test-restest reliability

  Reliability (trial 2 versus 3 = directly versus remotely monitored) will be assessed using paired sample t-tests (or Wilcoxon signed-rank tests), Bland-Altman plots (with 95% limits of agreement), and intraclass correlations

  Study 2 - Trial 2 and 3 (separated by 2 to 5 days)

Secondary Outcomes (2)

• Adverse events

  Through study completion, an average of 2 years

• Level of comfort during test and perception of safety (qualitative)

  Study 2 - Trial 3 (semi-structured interview of 20 to 30 minutes following the completion of the last trial of the 6MST)

Study Arms (2)

Lab testing (study 1)

Two 3-hour laboratory visits (separated by 6 to 18 days) will be conducted. During the first laboratory visit, anthropometric measurements, pulmonary function tests and CPET on a cycle ergometer will be performed. During the second laboratory visit, spirometry will be repeated to ensure stability of the participants health state (particularly relevant for individuals with COPD). Thereafter, the 6MST and 6MWT will be performed in a randomized order, separated by a rest period of at least 30 minutes.

At home testing (study 2)

Three 1-hour home visits (separated by 2 to 5 days) will be conducted. The first trial of the 6MST (familiarization trial) will be conducted at the participant's home with the therapist present. The second and third trials of the 6MST will be performed in a randomized order, with either direct (therapist present at the home) or remote (therapist present through videoconferencing software, as in a telerehabilitation setting) monitoring.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with chronic obstructive pulmonary disease or interstitial lung disease followed in outpatient hospital settings

You may qualify if:

• Adult ≥ 40 years old
• Diagnosis of chronic obstructive pulmonary disease (GOLDa 2 to 4) or of interstitial lung disease (\> 6 months)
• Clinically stable for ≥ 4 weeks

You may not qualify if:

• Interstitial lung disease associated with connective tissue disease and sarcoidosis (often accompanied with multisystemic effects)
• Unstable or severe cardiac condition
• Invalidating rheumatologic or neurologic condition
• Weight exceeding maximal limits of exercise equipment (e.g., 130 kg for the stepper)
• Any other physical condition limiting or contraindicating exercise testing
• Simultaneous participation in another study requiring changes in medication
• Recent pulmonary rehabilitation (≤1 year, potential learning bias for the 6-minute walk test and the 6-minute stepper test)
• For arm 1 only: Use of oxygen therapy (unable to perform gas analysis with oxygen therapy)
• For arm 2 only: Participation in arm 1

Sponsors & Collaborators

• Laval University: lead
• Institut universitaire de cardiologie et de pneumologie de Québec, University Laval: collaborator
• Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL) - France: collaborator

Study Sites (3)

Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval

Québec, G1V 4G5, Canada

RECRUITING

Groupement des Hôpitaux de l'Institut Catholique de Lille

Lille, Hauts-de-France, 59000, France

RECRUITING

FormAction Santé

Pérenchies, Hauts-de-France, 59840, France

NOT YET RECRUITING

Related Publications (1)

• Bass A, Gephine S, Martin M, Belley M, Robic M, Fabre C, Grosbois JM, Dion G, Saey D, Chambellan A, Maltais F. Assessing Functional Capacity in Directly and Remotely Monitored Home-Based Settings in Individuals With Chronic Respiratory Diseases: Protocol for a Multinational Validation Study. JMIR Res Protoc. 2024 Jun 28;13:e57404. doi: 10.2196/57404.

  PMID: 38941132 DERIVED

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

Central Study Contacts

Alec Bass, PT, PhD

CONTACT

418-656-8711; alec.bass@criucpq.ulaval.ca

Marianne Belley

CONTACT

418-656-8711; marianne.belley@criucpq.ulaval.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: June 7, 2024
• Study Start: February 2, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: June 7, 2024

Record last verified: 2024-06

Locations

CA (1); FR (2)