Effort During Resistance Training in Type 2 Diabetes

N/AActive Not RecruitingNCT06497842

University of New Mexico48 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Type2 Diabetes Mellitus

Interventions

High-effort resistance exercise trainingBEHAVIORAL

Six sets per exercise, 8 repetitions per set.

Low-effort resistance exercise trainingBEHAVIORAL

Three sets per exercise, 4 repetitions per set.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

UNM Exercise Physiology Lab

Albuquerque, New Mexico, United States

Outcomes

Primary Outcomes

Glucose concentration

Average glucose concentration (measured in milligrams per deciliter of blood, with a continuous glucose monitoring device)

Time frame: For 60 hours before the first training session and for 60 hours after the last (32nd) training session

Secondary Outcomes

Adherence to the resistance training protocols

Adherence rate assessed using the Kaplan-Meier method

Time frame: 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)

Data from ClinicalTrials.gov

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