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临床试验/NCT07061158
NCT07061158已完成不适用

A Multidimensional Health Perspective: Analysis of the Effects of Yoga Intervention on Sleep Disorders in Older Adults

Beijing Sport University1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2024年9月2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
73
试验地点
1
主要终点
Pittsburgh Sleep Quality Index (PSQI)

研究概览

简要总结

This randomized controlled trial aims to evaluate the impact of a structured yoga intervention on multidimensional health outcomes in older adults with sleep disturbances. A total of 62 participants aged 60 years and older with varying degrees of sleep disorders were recruited and randomly assigned to either a yoga intervention group or a control group. The intervention group received a standardized yoga program for 4 months, conducted twice weekly (60 minutes per session), and guided by certified instructors. The yoga intervention included physical postures, breathing exercises, and meditation/relaxation techniques. Health outcomes were assessed at baseline, mid-intervention (8 weeks), and post-intervention (16 weeks), across five domains: sleep quality, daytime functioning, cognitive performance, physical fitness, and emotional well-being. This study aims to explore the feasibility, safety, and integrative effects of yoga as a non-pharmacological intervention for promoting health in the aging population.

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • ≥ 60 years, conforming to the World Health Organization's definition of the elderly population.
  • Presence of varying degrees of sleep disorder symptoms (e.g., difficulty falling asleep, sleep maintenance difficulties, early morning awakening), but without severe mental illness or other significant underlying diseases affecting sleep (e.g., dementia, severe depression).
  • Possessing basic comprehension abilities, voluntarily participating in the study, and signing informed consent.
  • Capable of cooperating with follow-up and intervention.
  • No severe physical dysfunction, cardiopulmonary disease, or other conditions limiting participation in light physical activities (such as yoga practice).

排除标准

  • Severe mental disorders, such as schizophrenia, bipolar disorder, or severe depression.
  • Severe cognitive impairment, making it impossible to cooperate with the intervention and subjective questionnaire assessments.
  • Unstable cardiovascular diseases or other major organic diseases (e.g., recent myocardial infarction, end-stage renal failure).
  • Severe visual or auditory impairments that affect the safety and adherence to practice.

结局指标

主要结局

Pittsburgh Sleep Quality Index (PSQI)

时间窗: Baseline, 2 Months Post-Intervention, and 4 Months Post-Intervention

The Pittsburgh Sleep Quality Index (PSQI) is an internationally recognized self-rated questionnaire used to assess subjective sleep quality. A higher total score indicates poorer sleep quality. It encompasses seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. This study assesses changes in the PSQI total score to determine the impact of yoga intervention on the overall sleep status of older adults with sleep disorders.

次要结局

  • Epworth Sleepiness Scale (ESS)(Baseline, 2 Months Post-Intervention, and 4 Months Post-Intervention)
  • Fatigue Scale-14 (FSS-14)(Baseline, 2 Months Post-Intervention, and 4 Months Post-Intervention)
  • Montreal Cognitive Assessment-Beijing Version (MoCA-BJ)(Baseline, 2 Months Post-Intervention, and 4 Months Post-Intervention)
  • Lower Limb Major Muscle Group Strength (Quadriceps Femoris, Hamstrings, Triceps Surae, Tibialis Anterior, Iliopsoas)(Baseline, 2 Months Post-Intervention, and 4 Months Post-Intervention)
  • Geriatric Depression Scale-15 (GDS-15)(Baseline, 2 Months Post-Intervention, and 4 Months Post-Intervention)
  • Self-Rating Anxiety Scale (SAS)(Baseline, 2 Months Post-Intervention, and 4 Months Post-Intervention)

研究者

发起方
Beijing Sport University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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