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Optimization of Pulmonary Rehabilitation Programmes: the OPTION Study (OPTION)

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ClinicalTrials.gov Identifier: NCT01933308
Recruitment Status : Unknown
Verified February 2014 by Véronique Pépin, Hopital du Sacre-Coeur de Montreal.
Recruitment status was:  Recruiting
First Posted : September 2, 2013
Last Update Posted : March 3, 2014
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Fonds de la Recherche en Santé du Québec
Concordia University
Information provided by (Responsible Party):
Véronique Pépin, Hopital du Sacre-Coeur de Montreal

Brief 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.

Condition or disease Intervention/treatment Phase
COPD Other: Continuous high intensity training-CT80 Other: Training at ventilatory threshold-CTVT Other: Interval training-IT Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Optimization of Pulmonary Rehabilitation Programmes: the OPTION Study
Study Start Date : March 2010
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Continuous high intensity training-CT80
All arms will receive standardized comprehensive self-management teaching from health care practitioners. At program completion, all subjects will receive the same standardized exercise recommendations. The exercise training program will consist of cycling on a calibrated cycle ergometer at the target intensity, three sessions per week for 12 weeks. Sessions will include a 10-minute warm-up, a training phase at the target intensity, and a 5-minute cool-down. The duration of the training phase will be adjusted such that the total amount of work performed per session will be comparable between the three interventions. The training phase for the CT80 will consist of exercising at 80% of peak work rate (target training intensity) for 25 minutes, for a total session duration of 40 minutes.
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 Name: Continuous exercise training at 80% of peak work rate

Experimental: Training at ventilatory threshold-CTVT
The exercise training program will consist of cycling on a calibrated cycle ergometer at the target intensity, three sessions per week for 12 weeks. Sessions will include a 10-minute warm-up, a training phase at the target intensity, and a 5-minute cool-down. The duration of the training phase will be adjusted such that the total amount of work performed per session will be comparable between the three interventions. The training phase for the CTVT will consist of exercising at the ventilatory threshold for a duration that will result in a total amount of work equivalent to the work that each patient would have done if he/she had been assigned to the CT80 arm. This approach has been used successfully in the past to isolate the effect of training intensity from that of total training dose.
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 Name: Continuous exercise training at the ventilatory threshold

Experimental: Interval training-IT
The exercise training program will consist of cycling on a calibrated cycle ergometer at the target intensity, three sessions per week for 12 weeks. Sessions will include a 10-minute warm-up, a training phase at the target intensity, and a 5-minute cool-down. The training phase for the IT will consist of intervals of 30 seconds of exercise at 100% of work peak interspersed with intervals of 30 seconds of rest. This approach to IT was selected because it was successfully used by Vogiatzis et al. [33] and was shown to be as effective as continuous exercise training at a moderate intensity. As with the CTVT and CT80 arms, the duration of the training phase will be adjusted for the IT arm such that the total amount of work will be equivalent.
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.
Other Name: High intensity interval training




Primary Outcome Measures :
  1. Exercise tolerance [ Time Frame: from week 0 to week 12 ]
    Endurance time to a constant-load cycling


Secondary Outcome Measures :
  1. Change in exercise tolerance [ Time Frame: from week 12 to week 52 ]
    Endurance time to a constant-load cycling

  2. Change in functional status [ Time Frame: from week 0 to week 12 to week 52 ]
    Distance covered on the endurance shuttle walking test

  3. Change in psychological status [ Time Frame: from week 0 to week 12 to week 52 ]
    Scores on the Beck Depression Inventory-II (BDI-II), the Anxiety Sensitivity Index (ASI), and the Self-Efficacy Scale (SES)

  4. Change in cognition [ Time Frame: from week 0 to week 12 to week 52 ]
    Scores on the Montreal Cognitive Assessment (MoCA), Digit span backward subtest from the Wechsler Adult Intelligence Scale-III, Trail Making Test part B, verbal fluency, Continuous Performance Task, Rey Auditory Verbal Learning Test, and copy of the Rey Osterrieth Complex Figure

  5. Change in health-related quality of life [ Time Frame: from week 0 to week 12 to week 52 ]
    Total score on the Chronic Respiratory Questionnaire (CRQ)

  6. Patient compliance to the target intensity [ Time Frame: every training session ]
    Average compliance rate (percent time spent at target heart rate) maintained throughout the 12-week program

  7. Adherence to exercise recommendations [ Time Frame: at week 52 ]
    The 7-day activity record


Other Outcome Measures:
  1. Control Measures [ Time Frame: week 0 ]
    Pulmonary function will be measured to confirm patient eligibility and clinical stability at the time of the assessments. It is not considered a study outcome because it has been repeatedly shown not to change after pulmonary rehabilitation. Subjects' medications, smoking status, number and duration of respiratory exacerbations, and number and length of hospitalisations will be recorded throughout the study by the research assistant. The season and site of intervention will be also recorded for each subject.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinically stable COPD
  • Age 40 years or older
  • Smoking history of at least 10 American pack-years (20 cigarettes per pack)
  • Post-bronchodilation forced expiratory volume in one second (FEV1) less than 80% of the predicted normal value
  • FEV1 to forced vital capacity (FVC) ratio less than 0.7

Exclusion Criteria:

  • exacerbation of respiratory symptoms in the past 4 weeks (change in dyspnoea or volume/colour of sputum, need for antibiotic treatment, or need for hospitalization)
  • any contraindication to exercise testing based on guidelines from the American Thoracic Society
  • any active condition other than COPD that can influence exercise tolerance (asthma, unstable coronary heart disease, left congestive heart failure, neoplasia, severe claudication, severe arthritis, etc.)
  • oxygen therapy
  • participation in a PR program in the past year
  • inability to complete baseline evaluations (including the achievement of a ventilatory threshold on the incremental cycling exercise test)

These eligibility criteria are mostly meant to differentiate COPD from other respiratory diseases and to ensure clinical stability and patient safety


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): NCT01933308


Contacts
Contact: Florian Bobeuf, PhD 514-338-2222 ext 3078 florian.bobeuf@gmail.com
Contact: Véronique Pépin, PhD 514 338 2222 ext 3166 v-pepin@crhsc.rtss.qc.ca

Locations
Canada, Quebec
Centre de Recherche de l'Hopital du Sacré-Coeur de Montréal Recruiting
Montréal, Quebec, Canada, H4J 1C5
Contact: Florian Bobeuf, PhD    514 338 2222 ext 3078    florian.bobeuf@gmail.com   
Contact: Véronique Pépin, PhD    514 338 2222 ext 3166    v-pepin@crhsc.rtss.qc.ca   
Principal Investigator: Véronique Pepin, PhD         
Sponsors and Collaborators
Véronique Pépin
Canadian Institutes of Health Research (CIHR)
Fonds de la Recherche en Santé du Québec
Concordia University
Investigators
Principal Investigator: Véronique Pépin, PhD Centre de Recherche de l'Hopital du Sacré-Coeur de Montréal - Concordia University

Publications:
TechnoGym. Wellness System. [cited 2006 September 25]; Available from: http://www.technogymusa.com/_vti_g7_plsystem.aspx?rpstry=11902_
Beck, A.T., et al., Cognitive Therapy of Depression. 1979, New York, NY: Guilford Press.
Strauss, E., E.M. Sherman, and O. Spreen, A compendium of neuropsychological tests: administration, norms, and commentary. 3rd ed. 2006, New-York, NY: Oxford University Press.
Ware, J.E., M. Kosinski, and S.D. Keller, SF-36 Physical and Mental Health Summary Measures. 1994, Boston, MA: The Health Institute, New England Medical Center.
Ware, J.E., et al., SF-36 Health Survey Manual and Interpretation Guide. 1993, Boston, MA: The Health Institute, New England Medical Center.
Pocock, S.J., Group sequential methods in the design and analysis of clinical trials. 1977: Biometrika 64.
Hintze, J. PASS 11. 2011 [cited 2012 August 29]; Available from: www.ncss.com.

Responsible Party: Véronique Pépin, PhD, Hopital du Sacre-Coeur de Montreal
ClinicalTrials.gov Identifier: NCT01933308     History of Changes
Other Study ID Numbers: OPTION
First Posted: September 2, 2013    Key Record Dates
Last Update Posted: March 3, 2014
Last Verified: February 2014

Keywords provided by Véronique Pépin, Hopital du Sacre-Coeur de Montreal:
Pulmonary Rehabilitation
Comparison of exercise training protocol
Exercise tolerance
Functional and quality of life status
Cognitive and psychological status
Compliance to exercise recommendations
Long term adherence to exercise recommendations