- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07477262
Health Effects of a Walking Program in a High-Quality Tourism Environment for Older Women
Amplifying Healthy Aging: How A High-Quality Tourism Environment (Yangshuo, China) Selectively Enhanced Exercise Outcomes for Older Women - A Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Guangxi
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Guilin, Guangxi, China, 541004
- Guangxi Residential Elderly Care Demonstration Base
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Experimental: Natural Environment Group (NCE)
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.
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A 10-week supervised walking program conducted in the high-quality natural tourism environment of Yangshuo.
Participants are accommodated in a local homestay with direct views of the iconic karst mountains.
Walking sessions are conducted on pre-selected, scenic, low-traffic riverside paths.
The program consists of group walking 5 days/week, 60 mins/session, at a target intensity of 60-70% heart rate reserve, objectively monitored using Polar H10 chest-worn heart rate sensors.
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Active Comparator: Active Comparator: Conventional Environment Group (CCE)
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.
|
A 10-week supervised walking program conducted in a standard institutional setting.
Participants reside in a local nursing home with views of institutional buildings or internal courtyards.
Walking sessions are conducted on pre-measured, paved urban streets surrounding the nursing home.
The program consists of group walking 5 days/week, 60 mins/session, at a target intensity of 60-70% heart rate reserve, objectively monitored using Polar H10 chest-worn heart rate sensors to match the exercise dose with the experimental group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Body Weight
Time Frame: Baseline (Week 0) and within one week post-intervention (Week 10)
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Measured in kilograms (kg) using a multi-frequency bioelectrical impedance analysis device (InBody 770) under standardized conditions.
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Baseline (Week 0) and within one week post-intervention (Week 10)
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Change in Body Mass Index (BMI)
Time Frame: Baseline (Week 0) and within one week post-intervention (Week 10)
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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.
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Baseline (Week 0) and within one week post-intervention (Week 10)
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Change in Body Fat Percentage
Time Frame: Baseline (Week 0) and within one week post-intervention (Week 10)
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Measured as percentage (%) of total body weight using multi-frequency bioelectrical impedance analysis (InBody 770) under standardized conditions.
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Baseline (Week 0) and within one week post-intervention (Week 10)
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Change in Lower-body Muscular Endurance
Time Frame: Baseline (Week 0) and within one week post-intervention (Week 10)
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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.
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Baseline (Week 0) and within one week post-intervention (Week 10)
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Change in Handgrip Strength
Time Frame: Baseline (Week 0) and within one week post-intervention (Week 10)
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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.
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Baseline (Week 0) and within one week post-intervention (Week 10)
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Change in Depressive Symptoms
Time Frame: Baseline (Week 0) and within one week post-intervention (Week 10)
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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) .
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Baseline (Week 0) and within one week post-intervention (Week 10)
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Change in State Anxiety
Time Frame: Baseline (Week 0) and within one week post-intervention (Week 10)
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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) .
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Baseline (Week 0) and within one week post-intervention (Week 10)
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Change in Mental Health-Related Quality of Life
Time Frame: Baseline (Week 0) and within one week post-intervention (Week 10)
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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) .
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Baseline (Week 0) and within one week post-intervention (Week 10)
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Change in Sleep Quality
Time Frame: Baseline (Week 0) and within one week post-intervention (Week 10)
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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.
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Baseline (Week 0) and within one week post-intervention (Week 10)
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Change in Perceived Mastery
Time Frame: Baseline (Week 0) and within one week post-intervention (Week 10)
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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) .
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Baseline (Week 0) and within one week post-intervention (Week 10)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: yu-fan Li, Guilin Tourism University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GTU [2024] No. 29
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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