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Active, Not Recruiting

NCT Number: NCT06208189

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

PreDiabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State Type 2 Diabetes Mellitus

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNM Exercise Physiology Lab

Albuquerque, New Mexico, 87131-0001, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

  12. 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)

  13. 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)

  14. 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)

  15. 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)

  16. 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)

  17. 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)

  18. 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)

  19. 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)

  20. 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)

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 17, 2024
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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