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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06208189
• Other study ID #: 2310089095
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: July 2024

Study information

• Verified date: March 2024
• Source: University of New Mexico
• Contact: Flavio De Castro Magalhaes, PhD
• Phone: 1(505)277-2664
• Email: fcm[@]unm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Glucose Intolerance
• PreDiabetes
• Prediabetic State
• Type 2 Diabetes Mellitus

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	UNM Exercise Physiology Lab	Albuquerque	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Prevalence of hyperglycemia	Time of glucose concentrations >180 mg/dL (measured in minutes)	For 48 hours during each situation (arm) of the study
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Prevalence of hypoglycemia	Time of glucose concentrations <70 mg/dL (measured in minutes)	For 48 hours during each situation (arm) of the study
Primary	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
Primary	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
Primary	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
Primary	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	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.
Secondary	Feeling scale	Discrete scale from -5 to +5, where higher values mean more positive feelings.	Before and immediately after the resistance exercise sessions.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.