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临床试验/NCT06261372
NCT06261372已完成不适用

The Influence of Mindfulness Meditation Combined With Progressive Muscle Relaxation Training on the Clinical Efficacy and Quality of Life of Hemodialysis Patients With Sarcopenia

Ningbo Medical Center Lihuili Hospital1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2023年8月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
49
试验地点
1
主要终点
KDQOLTM(Kidney Disease Quality of Life short Form) score

研究概览

简要总结

To study the effect of mindfulness meditation combined with progressive muscle relaxation training on clinical efficacy and quality of life in maintenance hemodialysis (MHD) patients with sarcopenia. Eligible sarcopenic patients in our hospital were randomly assigned to a control group (n = 24) and an intervention group (n = 25). The control group received conventional dialysis treatment, while the intervention group received mindfulness meditation combined with progressive muscle relaxation training during the interdialysis period in addition to conventional dialysis treatment. The effect of the intervention was evaluated after 12 weeks.To observe whether the combined intervention training can improve the motor ability and quality of life of patients with sarcopenia in a short period of time.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who met the sarcopenia criteria established by the Asian Working Group for Sarcopenia (AWGS) in 2014
  • Stable condition and generally good health status
  • Good compliance and ability to collaborate well with the physician
  • Undergoing hemodialysis three times per week for at least three months, with a KT/V ≥ 1.2
  • No significant cardiovascular or cerebrovascular complications (such as severe heart failure, severe arrhythmias, angina, and cerebrovascular diseases)
  • Patients with sarcopenia who met the clinical diagnostic criteria were selected to ensure the quality of the included patients

排除标准

  • Inability to complete handgrip strength, 6-meter walk test, 10 sit-to-stand tests, and the use of bioelectrical impedance analysis (BIA) due to contraindications
  • Coexistence of mental illness or severe cognitive or communication disorders

结局指标

主要结局

KDQOLTM(Kidney Disease Quality of Life short Form) score

时间窗: 3 months

The KDQOLTM score is between 0 and 100, and the higher the score, the better the health

high-sensitivity C-reactive protein (hsCRP)

时间窗: 3 months

hsCRP represents an inflammatory marker, and its concentration ranges from 0.0 to 10mg/L.

albumin(ALB)

时间窗: 3 months

Albumin represents a nutritional indicator, and its concentration ranges from 40 to 55g/L.

10 sit-to-stand test in seconds

时间窗: 3 months

The 10 sit-stand test represents exercise ability, and the shorter the time, the greater the exercise ability.

interleukin-6 (IL-6)

时间窗: 3 months

Interleukin 6 represents an inflammatory marker, and its concentration is 20pg/ml or less.

prealbumin (PA)

时间窗: 3 months

Prealbumin represents a nutritional indicator, and its concentration ranges from 0.20 to 0.43g/l.

Grip strength in kilograms

时间窗: 3 months

Grip strength represents exercise ability, and the larger it is, the more exercise ability it is.Its minimum value is zero, and its maximum value is unlimited.

6-meter walk test in metre per second

时间窗: 3 months

6-meter walk test represents exercise ability, and the larger it is, the more exercise ability it is.Its minimum value is zero metre per second, and its maximum value is unlimited.

次要结局

未报告次要终点

研究者

发起方
Ningbo Medical Center Lihuili Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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