Effort During Resistance Training in Type 2 Diabetes

NCT ID: NCT06497842

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-10
• Study Completion Date: 2026-02-01

Brief Summary

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.

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.

Conditions

Type2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

High-effort resistance exercise training

Intervention Type: BEHAVIORAL

Six sets per exercise, 8 repetitions per set.

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.

Group Type: EXPERIMENTAL

Low-effort resistance exercise training

Intervention Type: BEHAVIORAL

Three sets per exercise, 4 repetitions per set.

Interventions

High-effort resistance exercise training

Six sets per exercise, 8 repetitions per set.

Intervention Type: BEHAVIORAL

Low-effort resistance exercise training

Three sets per exercise, 4 repetitions per set.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of New Mexico

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Flavio De Castro Magalhaes, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

UNM Exercise Physiology Lab

Albuquerque, New Mexico, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

HRRC#24-101

Identifier Type: -

Identifier Source: org_study_id