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临床试验/NCT07477262
NCT07477262已完成不适用

Amplifying Healthy Aging: How A High-Quality Tourism Environment (Yangshuo, China) Selectively Enhanced Exercise Outcomes for Older Women - A Randomized Controlled Trial

Yu-fan Li1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年5月25日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Change in Body Weight

研究概览

简要总结

The goal of this randomized controlled trial is to evaluate the effect of environmental context on the health benefits of a standardized walking program in sedentary, overweight older women (aged ≥60 years, BMI ≥24.0 kg/m²) . The main questions it aims to answer are:

Does exercising in a high-quality natural tourism environment (Yangshuo) lead to greater improvements in body composition (e.g., body fat percentage) compared to exercising in a conventional institutional setting?

Does this environment lead to greater improvements in psychological well-being (e.g., depressive symptoms, sleep quality) than the conventional setting?

Researchers will compare a group that walks in the Yangshuo landscape to a group that performs the same walking regimen in a nursing home setting to see if the natural environment amplifies the health benefits of the exercise.

Participants in both groups will take part in a supervised, 10-week walking program (5 days/week, 60 mins/session). All participants will have their physiological (e.g., weight, body fat, strength) and psychological (e.g., mood, sleep, quality of life) health measured before and after the program.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
60 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female sex.
  • Age ≥ 60 years.
  • Body mass index (BMI) ≥ 24.0 kg/m² (consistent with Chinese criteria for overweight status).
  • Sedentary lifestyle, defined as engaging in < 60 minutes of moderate-intensity exercise per week over the preceding 6 months.
  • Ability to walk independently without assistive devices.
  • Sufficient cognitive capacity to understand the study protocol and provide written informed consent.

排除标准

  • Severe or uncontrolled cardiometabolic conditions (e.g., heart failure, unstable angina).
  • Musculoskeletal disorders contraindicating exercise.
  • Major psychiatric disorders.
  • Planned extended absence during the 10-week intervention period.

研究组 & 干预措施

Experimental: Natural Environment Group (NCE)

Experimental

Participants in this group will complete a 10-week supervised walking program (5 days/week, 60 mins/session) conducted along scenic riverside paths in the Yangshuo karst landscape. They will be accommodated in a local homestay with direct views of the mountains. Exercise intensity is targeted at 60-70% of heart rate reserve, monitored by Polar H10 sensors.

干预措施: Walking Program in Natural Tourism Environment (Behavioral)

Active Comparator: Conventional Environment Group (CCE)

Active Comparator

Participants in this group will complete an identical 10-week supervised walking program (5 days/week, 60 mins/session) conducted on paved urban streets surrounding a local nursing home. They will reside in their usual accommodation within the nursing home. Exercise intensity is targeted at 60-70% of heart rate reserve, monitored by Polar H10 sensors.

干预措施: Walking Program in Conventional Institutional Environment (Behavioral)

结局指标

主要结局

Change in Body Weight

时间窗: Baseline (Week 0) and within one week post-intervention (Week 10)

Measured in kilograms (kg) using a multi-frequency bioelectrical impedance analysis device (InBody 770) under standardized conditions.

Change in Body Mass Index (BMI)

时间窗: Baseline (Week 0) and within one week post-intervention (Week 10)

Calculated as weight in kilograms divided by height in meters squared (kg/m²). Height measured at baseline using a stadiometer; weight measured at each time point using the InBody 770 device.

Change in Body Fat Percentage

时间窗: Baseline (Week 0) and within one week post-intervention (Week 10)

Measured as percentage (%) of total body weight using multi-frequency bioelectrical impedance analysis (InBody 770) under standardized conditions.

Change in Lower-body Muscular Endurance

时间窗: Baseline (Week 0) and within one week post-intervention (Week 10)

Assessed by the 30-second chair stand test, measuring the number of full stands completed in 30 seconds from a seated position. Higher numbers indicate better lower-body muscular endurance.

Change in Handgrip Strength

时间窗: Baseline (Week 0) and within one week post-intervention (Week 10)

Measured in kilograms (kg) using a calibrated handgrip dynamometer. Participants performed the test with their dominant hand, and the best of two trials was recorded. Higher values indicate greater handgrip strength.

Change in Depressive Symptoms

时间窗: Baseline (Week 0) and within one week post-intervention (Week 10)

Assessed using the Center for Epidemiologic Studies Depression Scale (CES-D) . This 20-item scale measures the frequency of depressive symptoms experienced in the past week. Total scores range from 0 to 60, with higher scores indicating more severe depressive symptoms (a worse outcome) .

Change in State Anxiety

时间窗: Baseline (Week 0) and within one week post-intervention (Week 10)

Assessed using the State subscale of the State-Trait Anxiety Inventory (STAI-S) . This 20-item scale measures transient anxious emotional states at the moment of assessment. Total scores range from 20 to 80, with higher scores indicating higher levels of state anxiety (a worse outcome) .

Change in Mental Health-Related Quality of Life

时间窗: Baseline (Week 0) and within one week post-intervention (Week 10)

Assessed using the Mental Component Summary (MCS) of the 36-Item Short Form Health Survey (SF-36) . This score is a standardized T-score based on normative data, with a population mean of 50 and a standard deviation of 10. Higher scores indicate better mental health-related quality of life (a better outcome) .

Change in Sleep Quality

时间窗: Baseline (Week 0) and within one week post-intervention (Week 10)

Assessed using the Pittsburgh Sleep Quality Index (PSQI) . This 19-item instrument assesses sleep quality and disturbances over a one-month period. The global score ranges from 0 to 21, with higher scores indicating poorer sleep quality (a worse outcome) . A global score \>5 is indicative of poor sleep quality.

Change in Perceived Mastery

时间窗: Baseline (Week 0) and within one week post-intervention (Week 10)

Assessed using the Pearlin-Schooler Mastery Scale. This 7-item scale measures the extent to which individuals perceive themselves as having personal control over factors that significantly impact their lives. Total scores range from 7 to 28, with higher scores indicating a stronger sense of personal mastery (a better outcome) .

次要结局

未报告次要终点

研究者

发起方
Yu-fan Li
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yu-fan Li

Lecturer

Guilin Tourism University

研究点 (1)

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