Is the Degree of Perceived Effort During Resistance Exercise Important for Improvements in Blood Glucose

September 3, 2026 updated by: Flavio de Castro Magalhaes, University of New Mexico

The Effect of Effort During a Resistance Exercise Session on Glycemic Control in Individuals With Prediabetes or Type 2 Diabetes Mellitus: a Randomized-controlled Trial

The goal of this clinical trial is to compare the degree of effort during a resistance exercise session on blood glucose levels in individuals with prediabetes or type 2 diabetes mellitus. The main questions it aims to answer are:

  • Do individuals with prediabetes or type 2 diabetes mellitus need to perform resistance exercise with a high degree of effort for their blood glucose to improve?
  • How do they feel (their enjoyment, discomfort) after the sessions with different degrees of effort?

Participants will perform 3 situations separated by at least 4 days, after being familiarized with all exercises and procedures:

  • One control day, when they will not exercise;
  • A high-effort resistance exercise session;
  • A low-effort resistance exercise session Researchers will measure blood glucose levels and psychological responses after these situations to see if the effort was important for the improvement of their blood glucose and how effort affected the way they felt after each situation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not 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.

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.
15

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.
  • Name: Flavio De Castro Magalhaes, PhD
  • Phone Number: 1(505)277-2664
  • Email: fcm@unm.edu

Study Locations

  • United States
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131-0001
        • UNM Exercise Physiology Lab

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:

  • age between 18 and 75 years;
  • presence of prediabetes (fasting glycemia between 100 and 125 mg/dL or glycated hemoglobin [A1c] between 5.7 and 6.4%) or T2DM (fasting glycemia 126 mg/dL or above or A1c 6.5% or above).

Exclusion Criteria:

  • renal failure,
  • liver disease,
  • uncontrolled hypertension (equal or greater than 160 mmHg systolic and/or equal or greater than 100 mmHg diastolic),
  • history of severe cardiovascular problems,
  • in case of oral hypoglycemic drugs usage, being on them for less than 6 months,
  • inability to perform resistance exercise,
  • being pregnant or trying to become pregnant during the course of the study,
  • use of oral contraceptives,
  • prisoners,
  • persons requiring a legally authorized representative,
  • non-English speakers.

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: Single

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.
Experimental: high-effort session
Participants will perform sets with as many repetitions they can each set.
Behavioral: High-effort session
Participants will perform 3 sets per exercise (total of 21 sets) with as many repetitions they can each set. We anticipate participants will perform ~10 repetitions per set in this session, with a total tempo of ~2.5 seconds per rep, averaging ~25 seconds per set. Resting period between exercises and sets will be 120 seconds. This will lead to a total session time of ~50 min. Their glycemic control will be evaluated during the following ~48 hours.
Experimental: low-effort session
Participants will perform sets with half of the anticipated number of repetitions of the high-effort session.
Behavioral: Low-effort session
Participants will perform 6 sets per exercise (total of 42 sets) but perform half of the anticipated number of repetitions of the HIGH session (i.e., 5 reps). Repetition tempo at ~2.5 seconds will result in ~12.5 seconds per set. Resting period between exercises and sets will be 60 seconds. This prescription will also lead to a total session time of ~50 min. Thus, both the HIGH and LOW session will have similar total volume-load and session density, but differ in perceived effort after each set. Their glycemic control will be evaluated during the following ~48 hours.
Sham Comparator: Control session
The control session all procedures will be identical to the high-effort session.
Behavioral: Control
The control session all procedures will be identical to the HIGH session, with the exception of performing the resistance exercises. However, to simulate all other procedures participants will follow all instructions, be positioned on the equipment for the same amount of time as the HIGH session, but will not perform any repetition. Interval between fake sets and exercises will be 120 seconds. Their glycemic control will be evaluated during the following ~48 hours.

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
Glucose concentration
Time Frame: For 48 hours during each situation (arm) of the study
Average glucose concentration (measured in milligrams per deciliter of blood, with a continuous glucose monitoring device)
For 48 hours during each situation (arm) of the study
Glucose concentration
Time Frame: For 6 hours during the morning (6 am - 12 pm) of each situation (arm) of the study
Average glucose concentration (measured in milligrams per deciliter of blood, with a continuous glucose monitoring device)
For 6 hours during the morning (6 am - 12 pm) of each situation (arm) of the study
Glucose concentration
Time Frame: For 6 hours during the afternoon (12 pm - 6 pm) of each situation (arm) of the study
Average glucose concentration (measured in milligrams per deciliter of blood, with a continuous glucose monitoring device)
For 6 hours during the afternoon (12 pm - 6 pm) of each situation (arm) of the study
Glucose concentration
Time Frame: For 6 hours during the evening (6 pm - 12 am) of each situation (arm) of the study
Average glucose concentration (measured in milligrams per deciliter of blood, with a continuous glucose monitoring device)
For 6 hours during the evening (6 pm - 12 am) of each situation (arm) of the study
Glucose concentration
Time Frame: For 6 hours during the nocturnal period (12 am - 6 am) of each situation (arm) of the study
Average glucose concentration (measured in milligrams per deciliter of blood, with a continuous glucose monitoring device)
For 6 hours during the nocturnal period (12 am - 6 am) of each situation (arm) of the study
Time in range
Time Frame: For 48 hours during each situation (arm) of the study
Time of glucose concentration between 70 and 180 mg/dL (measured in minutes)
For 48 hours during each situation (arm) of the study
Time in range
Time Frame: For 6 hours during the morning (6 am - 12 pm) of each situation (arm) of the study
Time of glucose concentration between 70 and 180 mg/dL (measured in minutes)
For 6 hours during the morning (6 am - 12 pm) of each situation (arm) of the study
Time in range
Time Frame: For 6 hours during the afternoon (12 pm - 6 pm) of each situation (arm) of the study
Time of glucose concentration between 70 and 180 mg/dL (measured in minutes)
For 6 hours during the afternoon (12 pm - 6 pm) of each situation (arm) of the study
Time in range
Time Frame: For 6 hours during the evening (6 pm - 12 am) of each situation (arm) of the study
Time of glucose concentration between 70 and 180 mg/dL (measured in minutes)
For 6 hours during the evening (6 pm - 12 am) of each situation (arm) of the study
Time in range
Time Frame: For 6 hours during the nocturnal period (12 am - 6 am) of each situation (arm) of the study
Time of glucose concentration between 70 and 180 mg/dL (measured in minutes)
For 6 hours during the nocturnal period (12 am - 6 am) of each situation (arm) of the study
Prevalence of hyperglycemia
Time Frame: For 48 hours during each situation (arm) of the study
Time of glucose concentrations >180 mg/dL (measured in minutes)
For 48 hours during each situation (arm) of the study
Prevalence of hyperglycemia
Time Frame: For 6 hours during the morning (6 am - 12 pm) of each situation (arm) of the study
Time of glucose concentrations >180 mg/dL (measured in minutes)
For 6 hours during the morning (6 am - 12 pm) of each situation (arm) of the study
Prevalence of hyperglycemia
Time Frame: For 6 hours during the afternoon (12 pm - 6 pm) of each situation (arm) of the study
Time of glucose concentrations >180 mg/dL (measured in minutes)
For 6 hours during the afternoon (12 pm - 6 pm) of each situation (arm) of the study
Prevalence of hyperglycemia
Time Frame: For 6 hours during the evening (6 pm - 12 am) of each situation (arm) of the study
Time of glucose concentrations >180 mg/dL (measured in minutes)
For 6 hours during the evening (6 pm - 12 am) of each situation (arm) of the study
Prevalence of hyperglycemia
Time Frame: For 6 hours during the nocturnal period (12 am - 6 am) of each situation (arm) of the study
Time of glucose concentrations >180 mg/dL (measured in minutes)
For 6 hours during the nocturnal period (12 am - 6 am) of each situation (arm) of the study
Prevalence of hypoglycemia
Time Frame: For 48 hours during each situation (arm) of the study
Time of glucose concentrations <70 mg/dL (measured in minutes)
For 48 hours during each situation (arm) of the study
Prevalence of hypoglycemia
Time Frame: For 6 hours during the morning (6 am - 12 pm) of each situation (arm) of the study
Time of glucose concentrations <70 mg/dL (measured in minutes)
For 6 hours during the morning (6 am - 12 pm) of each situation (arm) of the study
Prevalence of hypoglycemia
Time Frame: For 6 hours during the afternoon (12 pm - 6 pm) of each situation (arm) of the study
Time of glucose concentrations <70 mg/dL (measured in minutes)
For 6 hours during the afternoon (12 pm - 6 pm) of each situation (arm) of the study
Prevalence of hypoglycemia
Time Frame: For 6 hours during the evening (6 pm - 12 am) of each situation (arm) of the study
Time of glucose concentrations <70 mg/dL (measured in minutes)
For 6 hours during the evening (6 pm - 12 am) of each situation (arm) of the study
Prevalence of hypoglycemia
Time Frame: For 6 hours during the nocturnal period (12 am - 6 am) of each situation (arm) of the study
Time of glucose concentrations <70 mg/dL (measured in minutes)
For 6 hours during the nocturnal period (12 am - 6 am) of each situation (arm) of the study

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
Resistance Training Intensity by the Omni Perceived Exertion Scale
Time Frame: After each set of each exercise performed.
Discrete scale from 0 to 10, where higher values mean more perceived exertion.
After each set of each exercise performed.
Feeling scale
Time Frame: Before and immediately after the resistance exercise sessions.
Discrete scale from -5 to +5, where higher values mean more positive feelings.
Before and immediately after the resistance exercise sessions.
Physical Activity Enjoyment Scale
Time Frame: Immediately after the resistance exercise sessions.
Scale composed of 18 items, with scores from 1 to 7 each (total score from 18 to 126). After analysis, higher scores mean higher enjoyment.
Immediately after the resistance exercise sessions.
Self-efficacy scale
Time Frame: Immediately after the resistance exercise sessions.
Scale composed of 8 questions, with discrete options from 0 to 100%. Higher scores mean higher self-efficacy.
Immediately after the resistance exercise sessions.
Rating of Discomfort scale
Time Frame: Before and 5 minutes after the resistance exercise sessions.
Discrete scale from 0 to 100, where higher scores mean more discomfort.
Before and 5 minutes after the resistance exercise sessions.
Session rating of perceived exertion
Time Frame: 5 minutes after the resistance exercise sessions.
Discrete scale from 0 to 10, where higher values mean more perceived exertion.
5 minutes after the resistance exercise sessions.

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 New Mexico

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: Flavio De Castro Magalhaes, PhD, Assistant Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
June 12, 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.
October 30, 2026

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.
October 30, 2026

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).
December 28, 2023

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.
January 10, 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.
January 17, 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.
September 4, 2026

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.
September 3, 2026

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.
September 1, 2026

More Information

Terms related to this study

Keywords

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.
  • 2310089095

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

For sharing the data generated we will use the Open Science Framework (OSF) platform. Before data sharing, all personal identifiers will be stripped from the data. Specifically, any direct identifiers (e.g., name, email addresses, phone and cell phone numbers), date identifiers (e.g., birthday, date of disease diagnosis, dates patients participated in data collection), location identifiers (e.g., personal or professional addresses, zip codes), links to external datasets identifiers (e.g., social media accounts) will be removed. Furthermore, participants will be represented by an ID string generated randomly (https://www.random.org/strings/), and their data will be inserted in the files in a random order, not associated with the order they were enrolled. Thus, data will be entirely de-identified before sharing, in order to protect sensitive personal information and privacy.

IPD Sharing Time Frame

The anticipated date for data sharing will be 6 months after publication of data or 18 months after award end date, whatever happens first.

IPD Sharing Access Criteria

Freely accesible.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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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