Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 93 of 245 for:    "ottawa heart institute"

Exercise Training in Patients With Persistent or Permanent Atrial Fibrillation (Exercise-AF)

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.
ClinicalTrials.gov Identifier: NCT03397602
Recruitment Status : Recruiting
First Posted : January 12, 2018
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
Ottawa Heart Institute Research Corporation

Brief Summary:
The main purpose of this project is to evaluate the effects of high-intensity interval training (HIIT) compared to moderate-intensity continuous exercise training (MICE) and standard care on exercise capacity and quality of life in patients with persistent or permanent atrial fibrillation. Positive findings are vitally important for these patients, given the condition's substantial morbidity, mortality and high economic costs.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Behavioral: standard care + moderate-intensity continuous exercise training Behavioral: standard care + high-intensity interval training Not Applicable

Detailed Description:
Recommended standards of care do not include the prescription of exercise to target and ameliorate the progressive health decline and overall feeling of well-being in patients with atrial fibrillation. Recent Standards for the Provision of Cardiac Rehabilitation of Ontario are calling for the consideration for referral and enrollment of patients with atrial fibrillation in cardiovascular rehabilitation - evidence is needed to support and confirm these efforts. The main purpose of this project is to evaluate the effects of high-intensity interval training (HIIT) compared to moderate-intensity continuous exercise training (MICE) and standard care on exercise capacity and quality of life in patients with persistent or permanent atrial fibrillation. Positive results from this study will identify a new intervention that: produces important improvements in patient-rated clinical, behavioural and exercise outcomes; provides mechanistic insight into the role of exercise training in the management of atrial fibrillation; requires minimal equipment; and, is appealing to patients with atrial fibrillation.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Exercise Training in Patients With Persistent or Permanent Atrial Fibrillation - a Multi-centre Randomized Controlled Trial
Actual Study Start Date : January 23, 2019
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: standard care
Participants do not participate in a on site structured exercise training program.
Experimental: standard care + MICE
standard care + moderate-intensity continuous exercise training (MICE)
Behavioral: standard care + moderate-intensity continuous exercise training
Participants will attend on-site moderate-intensity continuous exercise training two times weekly for 12 weeks.

Experimental: standard care + HIIT
standard care + high-intensity interval training (HIIT)
Behavioral: standard care + high-intensity interval training
Participants will attend on-site high-intensity interval training two times weekly for 12 weeks.




Primary Outcome Measures :
  1. Changes in quality of life measured by the physical component summary (PCS) measure of the Short Form 36 Health Survey Questionnaire (SF-36). [ Time Frame: baseline to 12 weeks ]
    Changes in quality of life measured by the physical component summary (PCS) measure of the Short Form 36 Health Survey Questionnaire (SF-36) from baseline to 12 weeks.

  2. Changes in exercise capacity measured by VO2peak on a symptom-limited cardiopulmonary exercise test (CPET). [ Time Frame: baseline to 12 weeks ]
    Changes in exercise capacity measured by VO2peak on a symptom-limited cardiopulmonary exercise test (CPET) from baseline to 12 weeks.


Secondary Outcome Measures :
  1. Changes atrial fibrillation specific quality of life measured by the Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT). [ Time Frame: baseline to 12 weeks ]
    Changes atrial fibrillation specific quality of life measured by the Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT). The AFEQT assesses 4 domains: symptoms, activities, treatment concern, treatment satisfaction, and a summary score that includes the first 3 domains. Patients will assess the impact of AF on their health status during the previous 4 weeks. Responses are presented as a 7-point Likert scale. Raw scores within each domain are transformed to a 0 (most severe symptoms) to 100 scale (no limitations or disability). The AFEQT is valid, reliable and sensitive to clinical change in patients with AF undergoing different therapeutic interventions.

  2. Changes atrial fibrillation specific quality of life measured by the University of Toronto Atrial Fibrillation Severity Scale (AFSS). [ Time Frame: baseline to 12 weeks ]
    Changes atrial fibrillation specific quality of life measured by the University of Toronto Atrial Fibrillation Severity Scale (AFSS) from baseline to 12 weeks. The AFSS is a disease-specific quality of life measure used to capture subjective and objective ratings of disease burden in patients with atrial fibrillation. It assesses atrial fibrillation burden (score 1-30; higher scores indicate higher burden); Global Well Being (a visual analogue scale ranging from 1-10, indicating a patient reports as having a worst possible life [0] to the best possible life[10]); AF symptom score (score of 0-35; higher scores indicate more bothered by AF symptoms); and health care utilization (score of 0-21; higher scores indicate greater health care utilization).

  3. Changes in symptom burden measured by the Canadian Cardiovascular Society Severity of Atrial Fibrillation Scale. [ Time Frame: baseline to 12 weeks ]
    Changes in symptom burden measured by the Canadian Cardiovascular Society Severity of Atrial Fibrillation Scale from baseline to 12 weeks.The CCS-SAF is a simple, concise, symptom-based severity scale to assess patient status. CCS-SAF scores range from 0 to 4, with highest values denoting severe impact of symptoms on quality of life and activities of daily living. The CCS-SAF has been validated in patients with atrial fibrillation.

  4. Changes in quality of life measured by the mental component summary (MCS) measure of the Short Form 36 Health Survey Questionnaire (SF-36). [ Time Frame: baseline to 12 weeks ]
    Changes in quality of life measured by the mental component summary (MCS) measure of the Short Form 36 Health Survey Questionnaire (SF-36) from baseline to 12 weeks. The SF-36 is a widely used and thoroughly validated, standardized, generic health survey with 36 questions. It yields an 8-scale (physical functioning; role-physical; bodily pain; general health; vitality; social functioning; role-emotional; and, mental health) profile of functional health and well-being scores as well as psychometrically-based physical (PCS) and mental (MCS) component summary scores.

  5. Changes in heart rate control measured by 24-hour Holter ECG recordings and ECG recordings at each CPET. [ Time Frame: baseline to 12 weeks ]
    Changes in heart rate control measured by 24-hour Holter ECG recordings and ECG recordings at each CPET from baseline to 12 weeks.

  6. Changes in lower body muscular fitness measured by standard load tests. [ Time Frame: baseline to 12 weeks ]
    Changes in lower body muscular fitness measured by standard load tests from baseline to 12 weeks.

  7. Changes in volume and intensity of exercise measured directly by accelerometer. [ Time Frame: baseline to 12 weeks ]
    Changes in volume and intensity of exercise measured directly by accelerometer from baseline to 12 weeks.

  8. Changes in volume and intensity of exercise measured by self-report (exercise logs). [ Time Frame: baseline to 12 weeks ]
    Changes in volume and intensity of exercise measured by self-report (exercise logs) from baseline to 12 weeks.

  9. Changes in self-reported symptom frequency and severity measured by the 7-day symptom diary. [ Time Frame: baseline to 12 weeks ]
    Changes in self-reported symptom frequency and severity measured by the 7-day symptom diary from baseline to 12 weeks.

  10. Changes in self reported sleep patterns measured by the 7-day sleep diary. [ Time Frame: baseline to 12 weeks ]
    Changes in self reported sleep patterns measured by the 7-day sleep diary from baseline to 12 weeks.

  11. Changes in blood biomarker concentrations (participants at the University of Ottawa Heart Institute site only). [ Time Frame: baseline to 12 weeks ]
    Changes in blood biomarker concentrations from baseline to 12 weeks (participants at the University of Ottawa Heart Institute site only).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  1. persistent or permanent atrial fibrillation;
  2. rate controlled with a resting ventricular rate of equal to or less than 100 bpm;
  3. able to perform a symptom-limited exercise test;
  4. at least 40 years of age (i.e. participants must be 40 years or older);

Exclusion Criteria:

  1. currently participating in routine exercise training (more than two times per week);
  2. unstable angina;
  3. diagnosed severe mitral or aortic stenosis;
  4. diagnosed hypertrophic obstructive cardiomyopathy with significant obstruction;
  5. pregnant, lactating or planning to become pregnant during the study period;
  6. unable to provide written, informed consent, or
  7. unwilling or unable to return for follow up at week 12.

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): NCT03397602


Contacts
Layout table for location contacts
Contact: Jennifer L Reed, PhD 613-696-7392 jreed@ottawaheart.ca
Contact: Matheus Mistura, MSc 613-696-7000 ext 15944 mmistura@ottawaheart.ca

Locations
Layout table for location information
Canada, Ontario
London Health Sciences Network Not yet recruiting
London, Ontario, Canada
University of Ottawa Heart Insititue Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Investigators
Layout table for investigator information
Principal Investigator: Jennifer L Reed, PhD Ottawa Heart Institute Research Corporation

Layout table for additonal information
Responsible Party: Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT03397602     History of Changes
Other Study ID Numbers: 0906
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ottawa Heart Institute Research Corporation:
atrial fibrillation
exercise

Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes