Clinical trial NCT06497842: Effort During Resistance Training in Type 2 Diabetes
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type2 Diabetes Mellitus
Keywords: Resistance training
Degree of effort
Glycemic control
Continuous glucose monitoring
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2024-07-12
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will undergo anthropometrics, familiarization, and strength test, and will be randomized to a high-effort, or a low-effort resistance training protocol, that will be carried out 2 days/week, for 16 weeks, and will be composed of 7 exercises (hex bar squat, seated chest press, leg press, lat pulldown, leg extension, shoulder press, leg curl, always in this order). Load will be set at 10-RM load (75% 1-RM). Participants will be instructed to perform the concentric (lifting) phase of the repetition as fast as they can (\~0.5 seconds), and to perform the eccentric phase in 2 seconds. Psychological responses (perceived exertion, enjoyment, feeling scale, discomfort, and self-efficacy) will be assessed. Anthropometrics will be repeated after training, and before and after the training period, glycemic control will be assessed via a continuous glucose monitoring device. The main outcomes will be compared between training interventions, pre-training data will used as comparator.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Glucose concentration
timeFrame: For 60 hours before the first training session and for 60 hours after the last (32nd) training session
Secondary outcomes:
measure: Adherence to the resistance training protocols
timeFrame: 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)
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: UNM Exercise Physiology Lab
state: New Mexico
Study officials:
affiliation: Assistant Professor
name: Flavio De Castro Magalhaes, PhD
role: PRINCIPAL_INVESTIGATOR
References: