The Effect of High-Intensity Interval Training on Glucose Variability and Atrial Fibrillation Symptoms
Glucose-AF
Examining the Role of High-intensity Interval Training on Glucose Variability and Symptomatology: A Novel Approach for Patients With Atrial Fibrillation and Diabetes
1 other identifier
interventional
12
1 country
1
Brief Summary
The incidence of atrial fibrillation (AF), the most common heart rhythm disorder, is increasing. The symptoms of AF include: unpleasant heartbeats; difficulty breathing; tiredness; dizziness; and, reduced exercise capacity. Patients with AF have lower quality of life, higher mental distress, and higher risk of heart disease and stroke when compared to the general population. Further, patients with non-permanent AF tend to experience more severe symptoms and substantial reductions in quality of life when compared to patients with permanent AF. Type 2 diabetes increases the risk of developing AF and accounts for about 20% of patients with non-permanent AF. High blood glucose concentrations and increased blood glucose fluctuations (large and frequent upward and downward blood glucose swings) are commonly seen in type 2 diabetes. Increased blood glucose fluctuations may worsen AF symptoms and quality of life in patients with AF. Exercise improves quality of life and mental health and reduces risk of developing heart disease and stroke. However, no clinical guidelines for managing AF include exercise. High-intensity interval training (HIIT), a form of exercise that alternates between intense bouts of exercise and less intense recovery periods, is a time-efficient approach to improve blood glucose fluctuations in type 2 diabetes. In healthy individuals and in patients with coronary artery disease, HIIT also improves quality of life and mental health. Currently, the effect of HIIT on blood glucose fluctuations, AF symptom severity and quality of life in patients with AF living with type 2 diabetes is unknown. Also, the links between blood glucose fluctuations and AF symptom severity and quality of life have not been investigated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable atrial-fibrillation
Started Nov 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 29, 2019
CompletedFirst Posted
Study publicly available on registry
December 9, 2019
CompletedStudy Start
First participant enrolled
November 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 10, 2023
CompletedMay 7, 2024
May 1, 2024
1.9 years
November 29, 2019
May 6, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Glucose variability
Change in glucose variability as measured by the continuous glucose monitoring system
From baseline to follow-up after 4-week intervention
Secondary Outcomes (5)
Atrial fibrillation symptom severity
From baseline to follow-up after 4-week intervention
Atrial fibrillation-related quality of life
From baseline to follow-up after 4-week intervention
General quality of life
From baseline to follow-up after 4-week intervention
Sleep quality
From baseline to follow-up after 4-week intervention
Changes in blood biomarker concentrations
From baseline to follow-up after 4-week intervention
Other Outcomes (1)
Link between glucose variability and atrial fibrillation symptom severity
From baseline to follow-up after 4-week intervention
Study Arms (2)
High-intensity interval training
EXPERIMENTALParticipants will complete 12 supervised high-intensity interval exercise sessions (3 times weekly for 4 weeks).
Standard care
NO INTERVENTIONParticipants will not participate in on-site supervised exercise sessions.
Interventions
HIIT sessions will include: (1) warm-up for 2 minutes at 50% of peak power output (PPO); (2) 2 x 8-minute interval training blocks (total: 16 minutes) of 30-seconds at 80-100% of PPO interspersed with 30-seconds active recovery, 4 minutes of recovery will be permitted between the blocks; and, (3) 2 minute cool-down at 25% of PPO after the last 30-second exercise bout.
Eligibility Criteria
You may qualify if:
- non-permanent atrial fibrillation
- diagnosed with type 2 diabetes
- non-smokers
- able to perform a symptom-limited cardiopulmonary exercise test (CPET)
- rate controlled with a resting ventricular rate of ≤110 beats per minute
You may not qualify if:
- uncontrolled type 2 diabetes (A1C \>10 % or presence of type 2 diabetes-related complications
- on exogenous insulin
- unstable diagnosed angina
- diagnosed severe mitral or aortic stenosis
- diagnosed hypertrophic obstructive cardiomyopathy with significant obstruction
- presence of self-reported alcohol or substance abuse
- unable to provide written, informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y4W7, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer L Reed, PhD
Ottawa Heart Institute Research Corporation
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2019
First Posted
December 9, 2019
Study Start
November 18, 2021
Primary Completion
October 10, 2023
Study Completion
October 10, 2023
Last Updated
May 7, 2024
Record last verified: 2024-05