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Atrial FibrillationGlucose-AFNCT04190212

The Effect of High-Intensity Interval Training on Glucose Variability and Atrial Fibrillation Symptoms

A study of Atrial Fibrillation and Type 2 Diabetes, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Atrial Fibrillation, Type 2 Diabetes
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteCanada
Study dates
18 Nov 2021to 10 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y4W7

Other trials in Canada

About this study

Official title: Examining the Role of High-intensity Interval Training on Glucose Variability and Symptomatology: A Novel Approach for Patients With Atrial Fibrillation and Diabetes

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.

Read the detailed description

There is a global epidemic of AF, the most common sustained cardiac arrhythmia, and type 2 diabetes (T2D). Given an aging population and physically inactive lifestyles, the prevalence of AF and T2D is expected to increase. AF is a progressive disorder with three principal subtypes: paroxysmal AF (AF that self-terminates within <7 days), persistent AF (AF that lasts >7 days and is terminated by medications or procedures) and permanent AF (patient and treating physician agree not to pursue further intervention). AF-related symptoms are disabling and highly variable, including exercise intolerance, palpitations, breathlessness, fatigue, dizziness and mental distress. Patients with non-permanent AF experience more severe symptoms when compared to those with permanent AF, and suffer from substantial reductions in quality of life (QoL) and increased risk of major cerebrovascular events, cardiovascular events and mortality.

T2D is a risk factor for developing AF and approximately 20% of non-permanent AF patients (i.e. paroxysmal and persistent AF) suffer from this condition. T2D is characterized by insulin resistance and insulin insufficiency leading to high blood glucose concentrations. Inadequate or poor glycemic control leads to increases in glycemic variability (GV, amplitude and frequency of blood glucose oscillations from either high to low or low to high). GV is considered to exacerbate AF symptoms severity by increasing: (1) inflammation; (2) oxidative stress; and, (3) autonomic nervous system dysfunction. Emerging evidence also highlights associations between GV and poor QoL and negative mood in patients with T2D.

High-intensity interval training (HIIT), a form of exercise that involves periods of short, intense exercise bouts interspersed by less intense recovery periods, has emerged as a time-efficient and practical approach to improving GV. Importantly, only 10 HIIT sessions over 2 weeks have been shown to lower GV in patients with T2D. A systematic review (N=50 studies) revealed that HIIT improves insulin resistance and blood glucose control (glycated hemoglobin A1C) when compared to controls (i.e. no exercise) in patients with metabolic syndrome or T2D. HIIT also increases QoL in patients with coronary artery disease (CAD) following 4 weeks of exercise training; reduces inflammatory markers (i.e. interleukin-6 [IL-6] and C-reactive protein [CRP]30) in patients with CAD; attenuates markers of oxidative stress in healthy adults in 3 weeks; and improves cardiac autonomic nervous system function in healthy sedentary men in 2 weeks.

The recent American Diabetes Association guidelines recommend HIIT as a strategy to control blood glucose in patients with T2D. However, neither national nor international clinical guidelines for managing AF include exercise. The absence of exercise from these guidelines in the face of increasing evidence of its physical and mental health benefits reflects a lost opportunity to provide AF patients with better treatment options, particularly those who suffer from concomitant T2D. The effects of HIIT on GV, AF symptom severity and QoL in non-permanent AF patients with T2D are unknown, and the associations between GV and AF symptom severity and QoL remain to be investigated. Examining the impact of HIIT on GV, AF symptom severity and QoL may provide a novel, feasible and time-efficient therapeutic option for non-permanent AF patients with T2D who are searching for better treatment options.

Being tested
High-intensity interval training + standard care
Keywords
high-intensity interval training, glycemic variability, continuous glucose monitoring system
Medical subject headings
Atrial Fibrillation, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-intensity interval training + standard careBehavioural

    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.

Study groups in NCT04190212
Study groupRoleWhat they receive
High-intensity interval trainingExperimentalParticipants will complete 12 supervised high-intensity interval exercise sessions (3 times weekly for 4 weeks).
Receives: Behavioral: High-intensity interval training + standard care
Standard careNo interventionParticipants will not participate in on-site supervised exercise sessions.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glucose variability

    Change in glucose variability as measured by the continuous glucose monitoring system

    Measured: From baseline to follow-up after 4-week intervention

Secondary outcomes (5)
  1. Atrial fibrillation symptom severity

    Changes in atrial fibrillation symptom severity as assessed by the University of Toronto Atrial Fibrillation Severity Scale (AFSS). The questions include: AF frequency; overall severity; duration of AF episodes; frequency of hospitalization, visits to emergency room and specialist; and overall well-being (Likert scale with 1 indicating "worst possible life" to 10 indicating "best possible life").

    Measured: From baseline to follow-up after 4-week intervention

  2. Atrial fibrillation-related quality of life

    Change in the AF-related quality of life will be assessed by the Atrial Fibrillation Effect on Quality of Life (AFEQT) Questionnaire.The questionnaire includes Likert scale ranging from 1 to 7. The score will be transformed to a 0 to 100 scale where higher score represents better AF-related quality of life.

    Measured: From baseline to follow-up after 4-week intervention

  3. General quality of life

    Change in general quality of life will be assessed by the Short Form 36 Health Survey Questionnaire (SF-36). It yields an 8-scale profile of functional health and well-being scores, with higher scores indicating better quality of life.

    Measured: From baseline to follow-up after 4-week intervention

  4. Sleep quality

    Change in the sleep quality will be assessed by the 3-day sleep diary and Pittsburgh Sleep Quality index (PSQI). A global PSQI score ranges from 0 to 21 with higher scores indicating worse sleep quality.

    Measured: From baseline to follow-up after 4-week intervention

  5. Changes in blood biomarker concentrations

    Changes in the blood biomarker concentrations linked to glucose variability and AF symptom severity.

    Measured: From baseline to follow-up after 4-week intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2019
  2. Study start18 Nov 2021
  3. Primary completion10 Oct 2023
  4. Study completion10 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04190212
Sponsor's protocol ID
20190687
Acronym
Glucose-AF
Status last verified
May 2024
First submitted
29 Nov 2019
Last updated
7 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study of Atrial Fibrillation and Type 2 Diabetes, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glucose variability (time frame: From baseline to follow-up after 4-week intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.

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