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临床试验/NCT06497842
NCT06497842
进行中(未招募)
不适用

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

University of New Mexico2 个研究点 分布在 1 个国家目标入组 48 人2024年9月10日

概览

阶段
不适用
干预措施
High-effort resistance exercise training
疾病 / 适应症
Type2 Diabetes Mellitus
发起方
University of New Mexico
入组人数
48
试验地点
2
主要终点
Glucose concentration
状态
进行中(未招募)
最后更新
上个月

概览

简要总结

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.

详细描述

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.

注册库
clinicaltrials.gov
开始日期
2024年9月10日
结束日期
2026年5月1日
最后更新
上个月
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • Living with type 2 diabetes mellitus

排除标准

  • 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,

研究组 & 干预措施

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.

干预措施: High-effort resistance exercise training

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.

干预措施: Low-effort resistance exercise training

结局指标

主要结局

Glucose concentration

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

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

次要结局

  • Adherence to the resistance training protocols(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))

研究点 (2)

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