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

NCT ID: NCT06208189

Last Updated: 2026-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-12

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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PreDiabetes Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized controlled, crossover, 3-way, clinical trial, following the SPIRIT and the TIDieR guidelines. After being considered eligible and agreeing to participate, participants will undergo anthropometrics assessment, familiarization sessions, and strength assessment before randomly carrying out 3 experimental (2 exercise and one control) periods, each composed of a total of \~48 hours, separated by at least 4 days. During the experimental periods diet will be strictly controlled and provided to the participants. Glycemic control will be assessed by a continuous glucose monitoring system throughout the experimental periods. The exercise sessions will be identical regarding total volume-load and session density, but proximity to failure in each set will be manipulated so effort will be different between the sessions. The control session will be identical in all procedures as the exercise sessions except that participants will remain sedentary.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Data and statistical analysis will be performed by a researcher blinded to groups and participants' identities.

Study Groups

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high-effort session

Participants will perform sets with as many repetitions they can each set.

Group Type EXPERIMENTAL

High-effort session

Intervention Type BEHAVIORAL

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.

low-effort session

Participants will perform sets with half of the anticipated number of repetitions of the high-effort session.

Group Type EXPERIMENTAL

Low-effort session

Intervention Type BEHAVIORAL

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.

Control session

The control session all procedures will be identical to the high-effort session.

Group Type SHAM_COMPARATOR

Control

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of New Mexico

OTHER

Sponsor Role lead

Responsible Party

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Flavio de Castro Magalhaes

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Flavio De Castro Magalhaes, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

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UNM Exercise Physiology Lab

Albuquerque, New Mexico, United States

Site Status

Countries

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United States

References

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Ramirez M, Gebauer M, Mermier C, Little JP, Lin L, Palley G, Hsiao YY, Mota Alvidrez RI, Mang ZA, Amorim FT, Tricoli V, De Castro Magalhaes F. The Effect of Effort During a Resistance Exercise Session on Glycemic Control in Individuals Living With Prediabetes or Type 2 Diabetes: Protocol for a Crossover Randomized Controlled Trial. JMIR Res Protoc. 2024 Nov 5;13:e63598. doi: 10.2196/63598.

Reference Type DERIVED
PMID: 39499920 (View on PubMed)

Other Identifiers

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2310089095

Identifier Type: -

Identifier Source: org_study_id

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