The Acute Effect of Low-intensity Movement Breaks on Glycemic Responses in Individuals With Type 2 Diabetes.

May 6, 2024 updated by: Jonathan Little, University of British Columbia

The Acute Effect of Low-intensity Movement Breaks on Glycemic Responses in Individuals With Type 2 Diabetes: a Randomized Controlled Crossover Trial

To conduct a randomized crossover trial to determine the acute impact of low-intensity movement breaks on glycemic control in physically inactive individuals living with type 2 diabetes using continuous glucose monitoring.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Participants will perform two, 48-hour experimental conditions separated by 24 hours while wearing a continuous glucose monitor to measure glycemic responses. The order of the trials will be randomized for each participant. The two trials will include an exercise condition (EX) and a control, non-exercise condition (CON). During the EX trial, participants will perform four low-intensity movement breaks per day on two consecutive days (i.e., Monday and Tuesday). The movement breaks will each be 1-minute in duration and consist of stretching and mobility-based exercises. During the CON trial, participants will be asked to refrain from any structured exercise during two consecutive days (i.e., Thursday and Friday). All meals will be provided to participants during the two 48-hour trials and will be standardized for a given participant. There will be a one-day wash out period in between the completion of both trials for all participants.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1V 3G1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged 30-75 years old.
  • Have physician-diagnosed type 2 diabetes.
  • Currently participating in less than 150 minutes of moderate-to-vigorous intensity aerobic exercise per week.
  • Have a body mass index between 18.5 and 40 kg/m2.
  • Have had a stable medication dosage and no changes to the number of prescribed medications for at least 6 months.
  • Able to maintain current medication doses during the study.
  • Able to maintain current physical activity patterns during the study.
  • HbA1c is less than or equal to 8.5%.
  • Have access to a computer, tablet, or smartphone for intervention delivery and tracking.
  • Can travel to McMaster University for in-person laboratory testing visits.
  • Can read, write, and understand English.
  • Anticipate having access to the internet for the duration of the intervention (i.e., over the next 3-4 months).
  • Cleared for exercise participation based on the CSEP Get Active Questionnaire and the Rose Angina Questionnaire.

Exclusion Criteria:

  • Taking 4 or more glucose-lowering medications.
  • Taking insulin.
  • Taking beta-blockers.
  • Taking 3 or more commonly prescribed medications for the prevention of cardiovascular disease (e.g., statins, antihypertensives).
  • Have had an episode of severe hypoglycemia in the past 6 months (defined as having neurological symptoms consistent with neuroglycopenia and required assistance in treatment by a second party).
  • Currently a cigarette smoker.
  • Have a chronic musculoskeletal condition that would prevent participation in exercise.
  • Have had a recent (within the last 2 years) cardiovascular event that prevents participation in exercise.
  • Experience angina upon exertion.
  • Have uncontrolled high blood pressure (hypertension) or an atypical blood pressure or pulse rate at rest or during exercise as determined by a physician.
  • Have a scheduled surgical procedure within the next 3-4 months that would prevent exercise participation.
  • Currently diagnosed with a cardiac or pulmonary disease (e.g., angina, arrythmia, exercise-induced bronchospasm) that would prevent exercise participation.
  • Have a psychiatric disorder that could prevent you from completing the study procedures or visits.
  • Have donated more than 0.5 L of blood within the last 4 weeks.
  • Currently following an extreme diet (e.g., very low carbohydrate/calorie, ketogenic) or taking dietary/nutritional supplements that impact glucose control (e.g., exogenous ketones).
  • Currently have diabetic ulcers, peripheral vascular disease, or diabetic neuropathy that will prevent participation in exercise.
  • Currently on dialysis.
  • Currently participating in another clinical trial that interferes with the study procedures.
  • Currently pregnant or planning on becoming pregnant during the intervention (i.e., within the next 3-4 months).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control (CON) Non-exercise control condition
No structured exercise on two consecutive days.
Experimental: Exercise (EX): Low-intensity movement breaks condition
Stretching and mobility-based exercises lasting 1-minute each performed 4 times per day on two consecutive days.
Other: Movement breaks
Stretching and mobility-based exercises lasting 1-minute each performed 4 times per day on two consecutive days.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean 24-h glucose concentration assessed using continuous glucose monitoring assessed using continuous glucose monitoring
Time Frame: 48-hour EX trial versus the 48-hour CON trial
The mean 24-h glucose per trial will be determined as the average of the two 24-h periods during that specific trial
48-hour EX trial versus the 48-hour CON trial

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time in range determined using continuous glucose monitoring
Time Frame: 48-hour EX trial versus the 48-hour CON trial
Percentage of time in range (3.9-10 mmol/L)
48-hour EX trial versus the 48-hour CON trial
Time above range determined using continuous glucose monitoring
Time Frame: 48-hour EX trial versus the 48-hour CON trial
Percentage of time above range (>10 mmol/L)
48-hour EX trial versus the 48-hour CON trial
Time below range determined using continuous glucose monitoring
Time Frame: 48-hour EX trial versus the 48-hour CON trial
Percentage of time above range (<3.9 mmol/L)
48-hour EX trial versus the 48-hour CON trial
Glycemic variability determined using continuous glucose monitoring
Time Frame: 48-hour EX trial versus the 48-hour CON trial
Glycemic variability will be assess using the Standard Deviation (SD), mean amplitude of glycemic excursions (MAGE), and the coefficient of variation (CV)
48-hour EX trial versus the 48-hour CON trial
Two-hour glucose area under the curve following standardized breakfast, lunch and dinner meals
Time Frame: 48-hour EX trial versus the 48-hour CON trial
The incremental area under the curve following breakfast, lunch and dinner (2 h post meal)
48-hour EX trial versus the 48-hour CON trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of British Columbia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
McMaster University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jonathan Little, PhD, University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 25, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H24-Acute-Movement-Breaks

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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