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

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: Not yet recruiting
• Conditions: Type 2 Diabetes Mellitus; PreDiabetes
• Intervention / Treatment: Behavioral: High-effort session; Behavioral: Low-effort session; Behavioral: Control

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resistance Training Intensity by the Omni Perceived Exertion Scale	Discrete scale from 0 to 10, where higher values mean more perceived exertion.	After each set of each exercise performed.
Feeling scale	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	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	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	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	Discrete scale from 0 to 10, where higher values mean more perceived exertion.	5 minutes after the resistance exercise sessions.

Collaborators and Investigators

• Sponsor: University of New Mexico
• Investigators: Principal Investigator: Flavio De Castro Magalhaes, PhD, Assistant Professor

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: December 28, 2023
• First Submitted That Met QC Criteria: January 10, 2024
• First Posted (Actual): January 17, 2024

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: type 2 diabetes mellitus; prediabetes; continuous glucose monitoring; glycemic control; strength exercise; degree of effort
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Diabetes Mellitus; Diabetes Mellitus, Type 2; Prediabetic State; Glucose Intolerance
• Other Study ID 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