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临床试验/NCT06579898
NCT06579898已完成不适用

The Effect of Progressive Resistance Exercise Training (PRET) on Cardiovascular Risk Factors in Adults With ID.

Erasmus Medical Center3 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2021年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
3
主要终点
Systolic blood pressure

研究概览

简要总结

Thanks to improved healthcare, the life expectancy of people with ID is increasing and is approaching that of the general population. Several studies have shown that most cardiovascular disease (CVRF) risk factors are as common or even more common in people with ID than in the general population. The guidelines of the American College of Sport Medicine (ACSM) state that a resistance training (RT) programme can can effectively reduce CVRF if performed at a high intensity. A secondary benefit of RT is the increase in muscle strength and muscle mass that can reduce and can improve the ability to perform activities of daily living (ADL), also two common problems in people with ID.

详细描述

This study has a repeated time series design with one study group. The study period will last one year and is divided into a 12-week baseline period, a 24-week intervention period (PRET programme), and a 12-week follow-up period. The PRET programme will take 24 weeks and consists of two sessions per week, with at least 48 hours between the sessions. The intervention will be led by experienced physiotherapists and physical activity instructors employed by the care providers. All instructors take part in a training prior to the study. In this training, the intervention protocol and exercises will be discussed and practiced ensuring that the intervention is delivered according to the protocol. Every session consists of seven exercises (RESID) to train all large muscle groups. The programme is in accordance with the ACSM guidelines and characterised by four mesocycles. Each mesocycle consists of six weeks of training. After each mesocycle the training intensity will increase gradually, and within each mesocycle the weights will be adjusted in a way that the intensity remains equal. Training intensity will be measured by the percentage of the heaviest load one can lift for one repetition (% of 1RM). In the first mesocycle, participants are introduced to the resistance exercises and familiarised to the training protocol. They will learn to perform the exercises safely and with good posture. During mesocycles 2, 3, and 4, the number of repetitions will be gradually decreased while the training intensity will be gradually increased until vigorous intensity is reached in the fourth mesocycle (80% of 1RM). The resting time between sets will depend on the training intensity and varies between 30 seconds and 2 minutes. The instructors will register attendance, training intensity, performed number of sets and repetitions, and the weights used for each exercise in a log.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •being 18 years or older;
  • •living in a residential facility or receiving care from one of the participating care providers;
  • •diagnosed with mild (IQ = 50-69) or moderate (IQ = 35-49) ID;
  • •diagnosed with metabolic syndrome, or at least two of the following CVRF: hypertension, hypercholesterolemia, diabetes mellitus type 2, or obesity.
  • •participants must be able to walk independently and able to follow instructions on posture and performance for good execution of the exercises

排除标准

  • •not able to follow instructions or physical limitations interfering with participation in training programme

研究组 & 干预措施

PRET

Experimental

All participants participate in a progressive resistance exercise training programme for 24 weeks.

干预措施: Progressive resistance exercise training (Other)

结局指标

主要结局

Systolic blood pressure

时间窗: through study completion, an average of 1 year

mm/Hg, Blood pressure is measured with a digital blood pressure device

Glycated Haemoglobin

时间窗: through study completion, an average of 1 year

mmol/mol, Outcome is measured with blood samples and analysed in a laboratory of ErasmusMC

LDL cholesterol

时间窗: through study completion, an average of 1 year

mmol/L, Outcome is measured with blood samples and analysed in a laboratory of ErasmusMC

Waist-hip ratio

时间窗: through study completion, an average of 1 year

cm, Waist-hip ratio is calculated after measuring waist circumference and hip circumference with a flexible tape measure.

次要结局

  • HDL cholesterol(through study completion, an average of 1 year)
  • Total cholesterol(through study completion, an average of 1 year)
  • Glucose(through study completion, an average of 1 year)
  • (I)ADL questionnaire(through study completion, an average of 1 year)
  • Muscle mass(through study completion, an average of 1 year)
  • Triglycerides(through study completion, an average of 1 year)
  • Muscle strength(through study completion, an average of 1 year)
  • Fall incidents(through study completion, an average of 1 year)
  • ABC questionnaire(through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kirsten de Oude MSc

Investigator

Erasmus Medical Center

研究点 (3)

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