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

NCT06208189 | Active Not Recruiting

• 1 other identifier: 2310089095
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

PreDiabetes; Type 2 Diabetes Mellitus

Keywords

strength exercise; degree of effort; glycemic control; continuous glucose monitoring; prediabetes; type 2 diabetes mellitus

Outcome Measures

Primary Outcomes (20)

• Glucose concentration

  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

  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

  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

  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

  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 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 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 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 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 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 of glucose concentrations \>180 mg/dL (measured in minutes)

  For 48 hours during each situation (arm) of the study

• Prevalence of hyperglycemia

  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 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 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 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 of glucose concentrations \<70 mg/dL (measured in minutes)

  For 48 hours during each situation (arm) of the study

• Prevalence of hypoglycemia

  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 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 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 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 Outcomes (6)

• Resistance Training Intensity by the Omni Perceived Exertion Scale

  After each set of each exercise performed.

• Feeling scale

  Before and immediately after the resistance exercise sessions.

• Physical Activity Enjoyment Scale

  Immediately after the resistance exercise sessions.

• Self-efficacy scale

  Immediately after the resistance exercise sessions.

• Rating of Discomfort scale

  Before and 5 minutes after the resistance exercise sessions.

Study Arms (3)

high-effort session

EXPERIMENTAL

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

Behavioral: High-effort session

low-effort session

EXPERIMENTAL

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

Behavioral: Low-effort session

Control session

SHAM COMPARATOR

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

Behavioral: Control

Interventions

High-effort session 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.

high-effort session

Low-effort session 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.

low-effort session

Control 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.

Control session

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

UNM Exercise Physiology Lab

Albuquerque, New Mexico, 87131-0001, United States

Location

Related Publications (1)

• 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.

  PMID: 39499920 DERIVED

MeSH Terms

Conditions

Prediabetic State; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Flavio De Castro Magalhaes, PhD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data and statistical analysis will be performed by a researcher blinded to groups and participants' identities.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 28, 2023
• First Posted: January 17, 2024
• Study Start: June 12, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 14, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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.
• Access Criteria: Freely accesible.

Locations

US (1)