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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
Sponsor study identifier
interventional
12
1 country
1
Study Start
November 18, 2021
Actual (reported)Primary Completion
October 10, 2023
Actual (reported)Study Completion
October 10, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 10, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 29, 2019
Actual (reported)December 9, 2019
Actual (reported)November 18, 2021
Actual (reported)October 10, 2023
Actual (reported)October 10, 2023
Actual (reported)Glucose variability
Change in glucose variability as measured by the continuous glucose monitoring system
From baseline to follow-up after 4-week intervention
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
Link between glucose variability and atrial fibrillation symptom severity
From baseline to follow-up after 4-week intervention
Participants will complete 12 supervised high-intensity interval exercise sessions (3 times weekly for 4 weeks).
Participants will not participate in on-site supervised exercise sessions.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y4W7, Canada
Jennifer L Reed, PhD
Ottawa Heart Institute Research Corporation
12 participants (actual enrollment reported by the registry).
First Submitted
November 29, 2019
First Posted
December 9, 2019
Study Start
November 18, 2021
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
October 10, 2023
Actual (reported)Study Completion
October 10, 2023
Actual (reported)Last Updated
May 7, 2024
Record last verified: 2024-05
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Source: ClinicalTrials.gov.
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