The CaNadian Standardized Pulmonary Rehabilitation Efficacy Trial

NCT02917915 | Completed

• 1 other identifier: Pro00066560
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic obstructive pulmonary disease (COPD) is a chronic lung disease primarily caused by smoking. Pulmonary rehabilitation (PR) is an evidence-based, interdisciplinary, and comprehensive intervention for COPD patients that includes patient assessment, exercise training, and self-management education to promote behavior changes. PR has been shown to be the most effective strategy to improve clinical health outcomes, and is now considered to be a standard of care intervention for individuals with COPD who remain symptomatic despite optimal drug therapies. Despite considerable evidence supporting the effectiveness of PR at enhancing clinical outcomes, it is unclear if PR influences the behaviors that promote COPD management (i.e., physical activity, medication adherence, self-managing exacerbations). In collaboration with the local clinical staff as well as national colleagues and the Canadian Thoracic Society, a new national pulmonary rehabilitation program has been co-developed that is designed to increase physical activity, medication adherence, and skills to help manage chronic lung diseases. The new program aims to increase people's confidence and autonomy for performing disease-management behaviors, and has been designed to be more effective at increasing physical activity, medication adherence, and disease management skills than previous pulmonary rehabilitation programs. The program is designed to be delivered within different settings of practice, including traditional PR centers, satellite sites (i.e., sites that are remote from the major institutions),with the use of Tele-health and web-based resources, and primary care medical centers. The effectiveness of the new Standardized Canadian PR program will be assessed relative to the traditional PR program. This trial is an important step towards establishing the necessary evidence that will then enable us to work on dissemination and implementation of this new standardized PR program across the country.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD; Emphysema; Chronic Bronchitis; Pulmonary rehabilitation; Lung Diseases, Obstructive

Outcome Measures

Primary Outcomes (1)

• Physical activity assessed as steps per day as evaluated by Fitbit

  Change from baseline physical activity to the end of rehabilitation (6-8 weeks) and 6 months post-rehabilitation

Secondary Outcomes (2)

• Patient adherence to exacerbation action plan

  6 months after rehabilitation has ended

• Medication adherence assessed by pharmacy refill records

  6 months after rehabilitation has ended

Other Outcomes (9)

• Multidimensional Self-efficacy for Exercise Scale

  Change from baseline to the end of rehabilitation (6-8 weeks) and 6 months post-rehabilitation

• Self-efficacy for Walking Scale

  Change from baseline to the end of rehabilitation (6-8 weeks) and 6 months post-rehabilitation

• Self-efficacy for Medication Adherence

  Change from baseline to the end of rehabilitation (6-8 weeks) and 6 months post-rehabilitation

Study Arms (2)

New Canadian Standardized PR

EXPERIMENTAL

* Education Content: exercise, living well with chronic lung disease, breathing management, conserving energy, pulmonary medications, inhaler devices, integrating exercise in your life, management of respiratory infections, management of aggravating environmental factors, management of stress \& anxiety, nutrition, leisure \& travel, getting a good night's sleep, enjoying intimacy, living in a smoke-free environment, integrating long-term oxygen into your life, keeping a healthy lifestyle. * Delivery style: During group sessions patients engage in active, participatory-based learning of program content. Workbooks are available. During one-on-one interactions motivational communication style (asking for permission before providing information, using open questions, etc.) is used.

Other: Canadian Standardized PR

Traditional PR

ACTIVE COMPARATOR

* Education Content: Exercise, anatomy, pulmonary diseases, healthier breathing, pulmonary medications, pulmonary devices, exercise action plan, allergies \& pulmonary function tests, health and air quality, healthier eating, travel, stress management \& relaxation, tips to remember/summary of content. * Delivery style: During group sessions, patients engage in passive learning of program content delivered in a lecture-style approach. Patients also receive one-on-one education regarding: dyspnea management/pacing, inhaler technique, exercise maintenance.

Other: Traditional PR

Interventions

Canadian Standardized PR OTHER

Patients attend pulmonary rehabilitation (PR) 3 days per week for 6 weeks or 2 days per week for 8 weeks. Patients receive 2 hours of exercise training (aerobic and resistance) and 1 hour of education designed to promote self-management. In this intervention patients will receive the New Canadian Standardized PR educational approach (experimental).

New Canadian Standardized PR

Traditional PR OTHER

Patients attend pulmonary rehabilitation (PR) 3 days per week for 6 weeks or 2 days per week for 8 weeks. Patients receive 2 hours of exercise training (aerobic and resistance) and 1 hour of education designed to promote self-management. In this intervention patients will receive the Traditional PR education approach (active comparator).

Traditional PR

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be enrolled into pulmonary rehabilitation within our affiliated PR sites, or in satellite Tele-health program, with a diagnosis of COPD confirmed by post-bronchodilator forced expiratory volume in 1 second by forced vital capacity (FEV1/FVC) ratio of less than 0.7.
• Patients must be able to read and communicate in English or French.

You may not qualify if:

• Patients enrolled into pulmonary rehabilitation with a diagnosis other than COPD will be excluded.
• Patients with cognitive impairments who are unable to accurately complete questionnaires will also be excluded.
• As part of standard rehabilitation referral procedures, all patients must be ambulatory and not have unstable cardiovascular disease.

Sponsors & Collaborators

• University of Alberta: lead
• McGill University: collaborator
• University of Toronto: collaborator
• Université de Sherbrooke: collaborator

Study Sites (1)

G. F. MacDonald Centre for Lung Health

Edmonton, Alberta, T5K 0L5, Canada

Location

Related Publications (1)

• Selzler AM, Jourdain T, Wald J, Sedeno M, Janaudis-Ferreira T, Goldstein R, Bourbeau J, Stickland MK. Evaluation of an Enhanced Pulmonary Rehabilitation Program: A Randomized Controlled Trial. Ann Am Thorac Soc. 2021 Oct;18(10):1650-1660. doi: 10.1513/AnnalsATS.202009-1160OC.

  PMID: 34004123 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Emphysema; Bronchitis, Chronic; Lung Diseases, Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases

Study Officials

• Michael K Stickland, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Michael Stickland, PhD, Assistant Professor

Study Record Dates

• First Submitted: September 23, 2016
• First Posted: September 28, 2016
• Study Start: January 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2021
• Last Updated: April 7, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)