Effort During Resistance Training in Type 2 Diabetes

The Effect of Perceived Effort in Resistance Training on Glycemic Control and Psychological Responses in Individuals Living With Type 2 Diabetes Mellitus: a Randomized-controlled, Parallel Group, Clinical Trial

In this study the primary aims are to investigate the effect of resistance exercise training with different degrees of effort on glycemic control and psychological variables in individuals living with type 2 diabetes mellitus. As a secondary aim, investigate adherence and dropout rates and reasons for dropping out and adhering or not to the protocols.

Study Overview

• Status: Active, not recruiting
• Conditions: Type2 Diabetes Mellitus
• Intervention / Treatment: Behavioral: High-effort resistance exercise training; Behavioral: Low-effort resistance exercise training

Detailed Description

Resistance exercise training can be both effective for the management of type 2 diabetes mellitus (T2DM) and appealing for individuals living with T2DM, and has been shown to be a viable exercise prescription option for this population. It has been suggested that the degree of effort is important for acute improvements in glucose metabolism and insulin sensitivity in individuals living with T2DM, although direct evidence of that is lacking. However, performing resistance exercise sets with a high degree of effort is associated with higher perceived exertion and discomfort, increased muscle soreness, negative perceptual responses, and higher neuromuscular fatigue and muscle damage. Taken together, these negative perceptual and physiological responses to resistance exercise sets performed with high degree of effort might negatively affect enjoyment, self-efficacy, and motivation during a resistance exercise session, ultimately reducing long-term adherence.

The primary aim of this study is to assess the effects resistance exercise training with different degrees of effort on glycemic control and psychological responses in individuals living with T2DM. Also, perceptual responses will be assessed to investigate how feelings experienced during resistance exercise training are altered relative to different degrees of effort. The hypothesis is that glycemic control will not be affected by the degree of effort, and improvements will be observed regardless of that. Also, it is hypothesized that the degree of effort will be associated with better psychological responses. The secondary aim of this study is to investigate and report adherence rate and reasons for adhering or not to the protocols. It is anticipated that adherence will be associated with the degree of effort and psychological responses experienced during training.

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

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:

• Living with type 2 diabetes mellitus

Exclusion Criteria:

• Have a significant cognitive impairment,
• Are non-ambulatory,
• Have lower extremity amputation,
• Have renal failure,
• Have liver disease,
• Have uncontrolled hypertension (>160 mmHg systolic and/or >100 mmHg diastolic),
• Have unstable cardiovascular disease,
• Have a history of severe cardiovascular problems,
• Have decompensated heart failure,
• Have uncontrolled arrhythmias,
• Have severe pulmonary hypertension (mean pulmonary arterial pressure >55 mm Hg),
• Have severe and symptomatic aortic stenosis,
• Have acute myocarditis, endocarditis, or pericarditis,
• Have aortic dissection,
• Have Marfan syndrome,
• Have unrepaired aortic aneurysm,
• Have proliferative diabetic retinopathy,
• Have rapidly progressive terminal illness,
• Are unable to perform resistance exercise to due preexisting musculoskeletal conditions (e.g., joint pain, chronic injury or tendinopathy),
• Are under biguanide (metformin) treatment, but are taking for less than 3 months,
• Have taken drugs known to increase the risk of tendon disorders (e.g., tendinopathy and tendon rupture) within the last 6 months. These drugs include, but may not be limited to: fluoroquinolones, glucocorticoids, aromatase inhibitors, anabolic steroids, antiretrovirals, isotretinoin, cephalexin, rituximab, sitagliptin, cephalosporins, azithromycin, and sulfonamides.
• Are pregnant or trying to become pregnant during the study,
• Are prisoners,
• Are persons that require a legally authorized representative.

Temporary exclusions include:

• Being subjected to recent surgeries for which resistance training is not recommended,
• Have symptomatic hernias,
• Have acute illness,
• Have recent fractures, or other injuries until resolved.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-effort; The high-effort protocol will entail performing 3 sets per exercise, 8 repetitions per set, ~2.5 seconds per repetition, with 120 seconds between sets and exercises.	Behavioral: High-effort resistance exercise training; Six sets per exercise, 8 repetitions per set.
Experimental: Low-effort; The low-effort protocol will entail performing 6 sets per exercise, 4 repetitions per set, ~2.5 seconds per repetition, with 60 seconds between sets and exercises.	Behavioral: Low-effort resistance exercise training; Three sets per exercise, 4 repetitions per set.

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 60 hours before the first training session and for 60 hours after the last (32nd) training session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to the resistance training protocols	Adherence rate assessed using the Kaplan-Meier method	From date of randomization until the date of first documented dropout from any cause, assessed up to 16 weeks (the end of the training period)

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 (Actual): September 10, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: June 28, 2024
• First Submitted That Met QC Criteria: July 9, 2024
• First Posted (Actual): July 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Continuous glucose monitoring; Resistance training; Glycemic control; Degree of effort
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: HRRC#24-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: For sharing the data generated the Open Science Framework (OSF) platform will be used. 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 identification string generated randomly (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: Open access
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No