Optimization of Pulmonary Rehabilitation Programmes: the OPTION Study

NCT01933308 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2019-02-22

No results posted yet for this study

Summary

Chronic obstructive pulmonary disease (COPD) has a profound impact on the lives of individuals who suffer from it. Participants with COPD are often caught in a downward spiral that goes from chronic airflow limitation to invalidity and poor quality of life. Exercise training is considered the key to successful pulmonary rehabilitation (PR) because it is responsible for much of the benefits associated with this intervention. However, despite current guidelines recommend high-intensity exercise training. the optimal exercise training protocol for PR participants has yet to be determined. Aims: The main goal of the proposed research project will be to determine the optimal exercise training protocol in PR. More specifically, the objectives will be to compare the effects of continuous high-intensity training (CT80), continuous training at the ventilatory threshold (CTVT), and interval training (IT) on various PR program outcomes and to compare participant compliance to the three training regimens. Methods: One hundred and twenty subjects will be recruited. Participants who meet the eligibility criteria and accept to participate in the study will be randomized to one of three groups: the CT80 group, the CTVT group, or the IT group. Session duration will be adjusted such that the total amount of work performed per session will be comparable between the three groups. Assessments will be made at baseline (week 0), at program completion (week 12), and one year after program start (year 1). The primary outcome measure will be short-term (12 weeks) change in exercise tolerance, as measured by the endurance time to constant-load cycling. Secondary outcome measures will include: long-term (1 year) change in exercise tolerance; short-term and long-term changes in functional status, psychological status, cognition, and health-related quality of life; average participant compliance to the target intensity throughout the 12-week program; and long-term adherence to exercise recommendations. Relevance: The proposed research will inform clinicians and scientists regarding which of the exercise training protocols currently used in PR is optimal for COPD participants by examining their short-term and long-term impact on physiological, functional, psychological, neuropsychological, behavioural and quality of life outcomes. For COPD participants, our findings have the potential to improve the effectiveness of a key intervention for the management of their disease.

Conditions

Interventions

OTHER

Continuous high intensity training-CT80

Continuous exercise training at 80% of peak work rate Heart rate (HR) response observed at their target training intensity will be identified from an incremental exercise test completed at baseline. Subjects will be asked to train within ±5beats/min of this HR. Subjects will also perform upper-extremity strength training, stretching and relaxation exercises. Overall, sessions will last approximately 2hrs, including cycling (45-60min), strength training (30min), stretching (10min) and relaxation exercises (20min). Sessions will be held on Mondays, Wednesdays and Fridays. Supervision will be provided by clinical exercise physiologists trained by Dr. Pepin. Self-management training (Living Well with COPD®) will be provided by a healthcare practitioner trained by Dr. Lavoie.

OTHER

Training at ventilatory threshold-CTVT

Continuous exercise training at the ventilatory threshold Heart rate (HR) response observed at their target training intensity will be identified from an incremental exercise test completed at baseline. Subjects will be asked to train within ±5beats/min of this HR. Subjects will also perform upper-extremity strength training, stretching and relaxation exercises. Overall, sessions will last approximately 2hrs, including cycling (45-60min), strength training (30min), stretching (10min) and relaxation exercises (20min). Sessions will be held on Mondays, Wednesdays and Fridays. Supervision will be provided by clinical exercise physiologists trained by Dr. Pepin. Self-management training (Living Well with COPD®) will be provided by a healthcare practitioner trained by Dr. Lavoie.

OTHER

Interval training-IT

High intensity interval training Heart rate (HR) response observed at their target training intensity will be identified from an incremental exercise test completed at baseline. Subjects will be asked to train within ±5beats/min of this HR. Subjects will also perform upper-extremity strength training, stretching and relaxation exercises. Overall, sessions will last approximately 2hrs, including cycling (45-60min), strength training (30min), stretching (10min) and relaxation exercises (20min). Sessions will be held on Mondays, Wednesdays and Fridays. Supervision will be provided by clinical exercise physiologists trained by Dr. Pepin. Self-management training (Living Well with COPD®) will be provided by a healthcare practitioner trained by Dr. Lavoie.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV
  • Fonds de la Recherche en Santé du Québec

    collaborator OTHER_GOV
  • Concordia University, Montreal

    collaborator OTHER
  • Véronique Pépin

    lead OTHER

Principal Investigators

  • Véronique Pepin, PhD · Centre de Recherche, Hopital du Sacré-Coeur de Montréal - Concordia University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2011-10-31
Completion
2012-07-31

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01933308 on ClinicalTrials.gov