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The CaNadian Standardized Pulmonary Rehabilitation Efficacy Trial (CoNSPiRE)

This study is currently recruiting participants.
Verified September 2017 by Michael Stickland, University of Alberta
Sponsor:
ClinicalTrials.gov Identifier:
NCT02917915
First Posted: September 28, 2016
Last Update Posted: September 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
McGill University
University of Toronto
Université de Sherbrooke
Information provided by (Responsible Party):
Michael Stickland, University of Alberta
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease (COPD) Other: Canadian Standardized PR Other: Traditional PR

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The CaNadian Standardized Pulmonary Rehabilitation Efficacy Trial

Resource links provided by NLM:


Further study details as provided by Michael Stickland, University of Alberta:

Primary Outcome Measures:
  • Physical activity assessed as steps per day as evaluated by Fitbit and self-report [ Time Frame: Change from baseline physical activity to the end of rehabilitation (6-8 weeks) and 6 months post-rehabilitation ]

Secondary Outcome Measures:
  • Patient adherence to exacerbation action plan [ Time Frame: 6 months after rehabilitation has ended ]
  • Medication adherence assessed by pharmacy refill records [ Time Frame: 6 months after rehabilitation has ended ]

Other Outcome Measures:
  • Multidimensional Self-efficacy for Exercise Scale [ Time Frame: Change from baseline to the end of rehabilitation (6-8 weeks) and 6 months post-rehabilitation ]
  • Self-efficacy for Walking Scale [ Time Frame: Change from baseline to the end of rehabilitation (6-8 weeks) and 6 months post-rehabilitation ]
  • Self-efficacy for Medication Adherence [ Time Frame: Change from baseline to the end of rehabilitation (6-8 weeks) and 6 months post-rehabilitation ]
  • COPD Knowledge [ Time Frame: Change from baseline to the end of rehabilitation (6-8 weeks), and 6 months post-rehabilitation ]
  • Psychological Need Satisfaction for Exercise Scale [ Time Frame: Change from baseline to the end of rehabilitation (6-8 weeks) and 6 months post-rehabilitation ]
  • Psychological Need Thwarting Scale [ Time Frame: Change from the end of rehabilitation (6-8 weeks) to 6 months after rehabilitation ]
  • Treatment Self-regulation Questionnaire [ Time Frame: Change from baseline to the end of rehabilitation (6-8 weeks) and 6 months post-rehabilitation ]
  • Functional exercise capacity assessed by the 6-minute walk test [ Time Frame: Change from baseline to the end of rehabilitation (6-8 weeks) and 6 months post-rehabilitation ]
  • Health-related quality of life assessed by the COPD Assessment Tool [ Time Frame: Change from baseline to the end of rehabilitation (6-8 weeks) and 6 months post-rehabilitation ]

Estimated Enrollment: 200
Actual Study Start Date: January 2017
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: New Canadian Standardized PR
  • 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
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).
Active Comparator: Traditional PR
  • 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
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).

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02917915


Contacts
Contact: Anne-Marie Selzler, M.A. 780-492-7424 aselzler@ualberta.ca
Contact: Michael K Stickland, PhD 780-492-3995 michael.stickland@ualberta.ca

Locations
Canada, Alberta
G. F. MacDonald Centre for Lung Health Recruiting
Edmonton, Alberta, Canada, T5K 0L5
Contact: Anne-Marie Selzler, M.A.    780-342-8951    aselzler@ualberta.ca   
Contact: Michael K Stickland, PhD    780-42-8951    michael.stickland@ualberta.ca   
Principal Investigator: Michael K Stickland, PhD         
Sub-Investigator: Anne-Marie Selzler, M.A.         
Sponsors and Collaborators
University of Alberta
McGill University
University of Toronto
Université de Sherbrooke
Investigators
Principal Investigator: Michael K Stickland, PhD University of Alberta
  More Information

Responsible Party: Michael Stickland, Michael Stickland, PhD, Assistant Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT02917915     History of Changes
Other Study ID Numbers: Pro00066560
First Submitted: September 23, 2016
First Posted: September 28, 2016
Last Update Posted: September 8, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Michael Stickland, University of Alberta:
COPD
Emphysema
Chronic Bronchitis
Pulmonary rehabilitation
Lung Diseases, Obstructive

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases