The Effect of Brief Bodyweight Exercise on Acute Glycemic... | NCT05144490

Studies
The Effect of Brief Bodyweight Exercise on Acute Glycemic Control in Healthy Inactive Adults

NCT05144490

Sponsor

McMaster University

Status

Completed

Last Update Posted

Jul 12, 2022Actual

Enrollment

35Actual

Phase

Not Applicable

Conditions

Exercise

Interventions

Exercise

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 6, 2021Actual

Primary Completion Date

Jun 30, 2022Actual

Completion Date

Jun 30, 2022Actual

First Submitted Date

Nov 22, 2021

First Submission Date that Met QC Criteria

Nov 22, 2021

First Posted Date

Dec 3, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 8, 2022

Last Update Posted Date

Jul 12, 2022Actual

Name	Class
York University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will investigate whether an 11-minute bodyweight exercise session can improve short-term glycemic control. Glycemic control refers to the process of how the body regulates blood sugar. The process can be measured in different ways. This study will use a small device called a continuous glucose monitor to measure changes in glucose levels over a 24-hour period. Participants will complete two trials and the investigators will compare glycemic control after the exercise session and a control period that does not involve exercise. Food intake will be controlled such that each participant will consume the same diet in both conditions. This study will help determine whether a single session of bodyweight exercise affects glycemic control.

Detailed Description

This study will investigate whether an 11-minute bodyweight exercise session can improve short-term glycemic control. Glycemic control will be assessed using continuous glucose monitoring for 24 hours following exercise or a control condition that does not involve exercise. The exercise and control periods will be directly supervised by a study investigator. Participants will complete two trials in a randomized, crossover manner separated by 7 days. Food intake will be controlled such that each participant will consume the same diet over the 24-hour period of measurement in both conditions. Standardized meals will be provided to participants prior and following the exercise and control conditions. This study will determine whether a single session of bodyweight exercise affects glycemic control as primarily assessed by mean 24-hour glucose.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bodyweight Exercise	Experimental	A standardized 11-minute bodyweight exercise session that involves a 1-minute warm-up followed by 5, 1-minute bouts of exercise at a self-selected "challenging" pace, interspersed with 1-minute periods of low-intensity exercise for recovery.	Other: Exercise
Non-Exercise Control	No Intervention	An 11-minute period of quiet sitting.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exercise	Other	A single session of bodyweight exercise	Bodyweight Exercise

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
24-hour mean glucose	Mean glucose following the bodyweight exercise or control condition	24-hour measurement period

Secondary Outcomes

Measure	Description	Time Frame
Glycemic variability	Variability in glucose measured following exercise or control	24-hour measurement period
Peak glucose	Peak glucose measured after each meal following exercise or control

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Inactive, defined as not meeting the physical activity targets in the Canadian 24-Hour Movement Guidelines for Adults.
Deemed able to safely participate in physical activity and exercise, as determined by the Canadian Society for Exercise Physiology (CSEP) Get Active Questionnaire prescreening tool.

Exclusion Criteria:

- Experiencing a condition that might preclude safe participation in physical activity and exercise, as determined by answering "Yes" to any question on Page 1 of the CSEP Get Active Questionnaire.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Martin Gibala, PhD	McMaster University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
McMaster University		Hamilton	Ontario	L8S4K1	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009043	Motor Activity

Ancestor Terms

ID	Term
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided