Amplifying Healthy Aging: How A High-Quality Tourism Environment (Yangshuo, China) Selectively Enhanced Exercise Outcomes for Older Women - A Randomized Controlled Trial
Phase: NA
Conditions: Overweight , Obesity
Sponsor: Yu-fan Li

STUDY PROTOCOL AND STATISTICAL ANALYSIS PLAN
Official Title:
Effects of a Standardized Walking Program in a High-Quality Natural Tourism Environment on
Health Outcomes in Sedentary, Overweight Older Women: A 10-Week Randomized Controlled
Trial
NCT Number:
Pending assignment upon registration
Document Date:
May 5, 2024
Protocol Version:
1.0 (Final)
Principal Investigator:
Yu-fan Li, Lecturer, Guilin Tourism University
Sponsor:
Guilin Tourism University
Funding Source:
Guangxi Young and Middle-aged University Faculty Research Capability Enhancement Project
for 2025 (Grant No. 2025KY0952)
Ethics Approval Reference:
Institutional Review Board of GTU scientific research (2024) No. 29
ClinicalTrials.gov Registration:
TABLE OF CONTENTS
1.
ABSTRACT
2.
INTRODUCTION
3.
OBJECTIVES AND HYPOTHESES
4.
STUDY DESIGN
5.
PARTICIPANTS
6.
INTERVENTIONS
7.
OUTCOME MEASURES
8.
STATISTICAL ANALYSIS PLAN
9.
ETHICAL CONSIDERATIONS
10. DATA MANAGEMENT AND CONFIDENTIALITY
11. DISSEMINATION POLICY

1. ABSTRACT
Background: Built and natural environments are recognized as key determinants of health
behaviors and outcomes. Sedentary, overweight older women face heightened risks of physical
and psychological decline. This study examines whether conducting a standardized walking
program within a high-quality tourism environment yields greater health benefits than the same
program in a conventional setting.
Methods: In this 10-week randomized controlled trial, 50 eligible women (age ≥60 years, BMI ≥
24.0 kg/m²) are assigned to either an experimental group (NCE, n = 25) that exercises in
Yangshuo's iconic karst landscape, or an active control group (CCE, n = 25) that performs the
identical supervised walking regimen in a nursing home setting. The program consists of group
walking sessions (5 days/week, 60 mins/session) at a target intensity of 60-70% heart rate reserve,
with exercise intensity objectively monitored. Physiological, psychological, and behavioral
outcomes are assessed at baseline and post-intervention.
Conclusion: This trial will determine whether a high-quality natural environment can selectively
enhance certain health outcomes within a standardized exercise program for older women.
2. INTRODUCTION
2.1 Background and Rationale
The 21st century is marked by a profound demographic transition toward aging populations
worldwide, a shift that has significant public health and economic implications. Older women are
particularly vulnerable, as they face a high prevalence of overweight and obesity. This excess
adiposity is not simply cosmetic; it can accelerate muscle loss (sarcopenia); impair mobility;
elevate the risk of chronic conditions, such as diabetes and hypertension; and ultimately erode
independence and quality of life. Further, the psychological well-being of this group is often
threatened by increased risks of depression, anxiety, and social isolation, creating a complex
interplay of physical and mental health decline.
Within this challenging landscape, physical exercise is well-established as an effective
non-pharmacological intervention. Research confirms that structured programs, particularly those
that blend resistance training with aerobic activity, are highly effective at mitigating age-related
decline. Meta-analyses consistently affirm benefits spanning improved body composition,
enhanced muscular strength and functional capacity, and reduced symptoms of depression and
anxiety. Consequently, regular physical activity is universally recommended as an important
component of healthy aging.
A growing body of evidence specifically highlights the unique value of outdoor physical activity,
such as walking, hiking, and other forms of exercise conducted in natural settings, beyond the
benefits of indoor exercise. While adherence to any exercise is beneficial, exercising outdoors has
been linked to distinct advantages that cannot be fully replicated indoors, such as higher levels of
enjoyment, greater feelings of revitalization, and increased positive affect during and after the
activity. These enhanced psychological responses are important, as enjoyment is a key predictor of
long-term exercise adherence. Furthermore, variable terrain, changing scenery, and exposure to

fresh air and natural light inherent in an outdoor exercise like walking can provide richer sensory
stimulation, potentially leading to superior cognitive engagement and mood regulation.
Importantly, for populations such as older adults, outdoor walking is a highly accessible,
low-impact activity that supports both cardiovascular health and functional mobility.
Despite this recognition, a critical and under-investigated gap persists in the literature. The
benefits of outdoor exercise are often presented generically, with insufficient attention paid to the
specific quality and characteristics of the natural environment itself. Not all "outdoor" or "natural"
settings are equal. Thus, a key question emerges: does conducting the same exercise prescription,
with identical frequency, intensity, time, and type (FITT principles), in a visually stunning,
restorative natural environment yield greater health benefits than when conducted in a bland,
confined, or less inspiring outdoor setting? Current research has predominantly focused on
comparing indoor versus outdoor exercise broadly, or on the presence versus absence of "green
space". This oversight neglects the potential for environmental aesthetics and restorative quality to
function as an active therapeutic ingredient that amplifies the effects of physical activity.
2.2 Theoretical Framework
The notion that the environment itself can serve as an active therapeutic agent is strongly
supported by theoretical frameworks that directly link environmental quality to well-being.
Kaplan's attention restoration theory (ART) provides a compelling explanation. It posits that
natural environments that offer a sense of "being away" (psychological distance from routine
demands), "fascination" (effortlessly capturing attention through aesthetic appeal), "extent" (a
coherent, immersive setting), and "compatibility" (alignment between environmental features and
an individual's purposes) are uniquely capable of restoring depleted cognitive and emotional
resources.
Similarly, Ulrich's stress reduction theory (SRT) proposes that exposure to aesthetically pleasing
natural scenes can trigger rapid, unconscious psychophysiological changes that promote stress
reduction, positive emotional states, and physiological relaxation. These theories suggest that a
high-quality natural environment does more than provide a venue for exercise; it interacts with the
individual to enhance the restorative and motivational processes during the activity.
Building on this, we posit that for structured health interventions, the defining environmental
factor is not simple outdoor access, but rather the rich, multisensory, restorative, and awe-inspiring
experience offered by a premier natural tourism destination. Characterized by their extraordinary
scenic beauty, cultural significance, and immersive qualities, such environments represent the
pinnacle of a restorative environment. They provide an ideal setting to test the hypothesis that
environmental quality can amplify the physical and mental health benefits derived from a
standardized exercise protocol.
2.3 Study Setting: Yangshuo, China
Yangshuo, China, a UNESCO World Heritage site, serves as our paradigm of such a high-quality

environment. Its iconic landscape of towering karst limestone peaks rising from tranquil rivers and
lush countryside is not merely a visual backdrop. For an older adult engaging in prescribed
walking sessions here, the environment actively contributes to the intervention. The awe-inspiring
scenery induces the "fascination" central to ART, while the physical displacement to a tourist
destination creates a sense of "being away" from daily routines and institutional confines. This can
lower psychological barriers to adopting a new exercise regimen. The natural beauty acts as a
potent positive distraction, making the perception of physical effort more manageable and
transforming exercise from a chore into an engaging, enjoyable experience. Moreover, such a
setting fosters a unique social atmosphere—a liminal space outside of normal life—that can
naturally encourage social interaction, strengthen group cohesion, and combat feelings of
loneliness, which are prevalent among older adults.
Therefore, we conceptualize the high-quality tourism environment of Yangshuo not as a passive
setting, but rather as an integral, active component of the therapeutic intervention, one that works
synergistically with the physiological stimulus of exercise.
3. OBJECTIVES AND HYPOTHESES
3.1 Primary Objective
To determine whether conducting a standardized 10-week supervised walking program in a
high-quality natural tourism environment (Yangshuo) leads to superior improvements in body
composition (body fat percentage, body weight, BMI) and muscular strength (lower-body
endurance and handgrip strength) compared to the same program conducted in a conventional
institutional setting (nursing home).
3.2 Secondary Objectives
To determine
whether
the
high-quality
natural
tourism
environment
leads
to
superior
improvements in:
- Depressive symptoms
- State anxiety
- Mental health-related quality of life
- Sleep quality
- Perceived personal mastery
3.3 Hypotheses
H1: Environmental Synergy Hypothesis for Physiological Gains: The group exercising in
Yangshuo (natural commercial environment, NCE) will achieve significantly greater reductions in
body fat percentage (H1a), body weight (H1b), and BMI (H1c), and greater improvements in
lower-body muscular strength (H1d) and handgrip strength (H1e) than the control group in the
conventional setting (conventional control environment, CCE).
H2: Environmental Facilitation Hypothesis for Psychological Restoration: The NCE group will

demonstrate significantly larger reductions in depressive (H2a) and anxiety (H2b) symptoms, and
a significantly greater increase in mental health-related quality of life (H2c) than the CCE group.
H3: Environmental Empowerment Hypothesis for Cognitive-Behavioral Outcomes: The NCE
group will show significantly greater improvements in sleep quality (H3a) and perceived personal
mastery (H3b) than the CCE group.
It is hypothesized that a significant Time × Group interaction will be observed for all outcome
measures, confirming that the superior environmental context of Yangshuo amplifies the benefits
derived from the standardized exercise protocol.
4. STUDY DESIGN
This investigation is a 10-week, two-arm, parallel-group randomized controlled trial to rigorously
evaluate the differential effects of environmental context on the outcomes of a standardized
exercise program.
Study Timeline:
- Participant recruitment: May 1, 2024 – June 30, 2024
- Intervention period: July 1, 2024 – September 8, 2024
- Post-intervention assessments: September 9, 2024 – September 15, 2024
- Data analysis: September 2024 – December 2024
Study Flow:
1.
Recruitment and screening
2.
Information session and informed consent
3.
Baseline assessments (T0)
4.
Randomization
5.
Intervention period (10 weeks)
- NCE group: Walking in Yangshuo environment
- CCE group: Walking in nursing home environment
6.
Post-intervention assessments (T1)
7.
Data analysis
Randomization:
Eligible participants will be randomly allocated to one of the two study groups using a
computer-generated sequence prepared by an independent researcher not involved in recruitment
or assessment, thereby ensuring robust randomization. Allocation concealment will be maintained
until after baseline assessments are completed.
Blinding:
The
researchers
responsible
for
conducting
all
outcome
assessments
at
baseline
and
post-intervention will be blinded to the participants' group allocation (NCE or CCE) throughout
the entire study period. Participants and exercise coaches cannot be blinded due to the nature of
the environmental intervention.

5. PARTICIPANTS
5.1 Target Population
Community-dwelling sedentary, overweight older women in the Guilin, China area.
5.2 Sample Size Calculation
Sample size was determined a priori using G*Power 3.1 software. Based on previous research
examining environmental effects on exercise outcomes, a medium effect size (f² = 0.25) was
assumed. For a 2 (group) × 2 (time) repeated-measures ANOVA, with power (1 – β) set at 0.80
and α = 0.05, the calculation indicated that at least 22 participants per group were required to
detect a significant interaction. Accounting for an estimated 10% attrition rate, a total of 50
participants (25 per group) will be recruited.
5.3 Eligibility Criteria
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
5.4 Recruitment
Participants will be recruited from the Guilin, China area through targeted local advertisements
and community outreach. Recruitment materials will include flyers posted in community centers,
senior activity centers, and local clinics, as well as word-of-mouth referrals.
5.5 Informed Consent Process
Prior to randomization and baseline assessment, all eligible participants will attend a dedicated
information session. During this session, the research team will thoroughly explain the study's
purpose, procedures, potential benefits, and foreseeable risks. The time commitment and
expectations for the 10-week intervention will be clarified. It will be explicitly emphasized that
participation is entirely voluntary and that participants reserve the right to withdraw from the
study at any point without penalty or detriment to their future care. Following this comprehensive
discussion and after all questions have been answered, individuals who voluntarily agree to
participate will provide written informed consent.

6. INTERVENTIONS
6.1 Overview
The core exercise intervention is identical for both groups, consisting of a supervised program
conducted 5 days per week over a 10-week period. Participants must attend at least four sessions
per week to be considered compliant with the protocol. The key differentiator between the groups
is the environmental context in which this program is delivered.
6.2 Experimental Group (NCE)
Setting: Participants in the NCE group will be accommodated in a carefully curated homestay
located within 200 meters of the scenic Yulong River area in Yangshuo, renowned for its
breathtaking karst topography. The homestay rooms are specifically selected to provide direct,
unobstructed views of the iconic karst mountains.
Walking Route: Outdoor walking sessions will be conducted on pre-selected, scenic, and
low-traffic riverside paths.
6.3 Active Comparator Group (CCE)
Setting: Participants in the CCE group will continue to reside in their usual accommodation within
a local nursing home facility. The views from their rooms encompass other institutional buildings
or internal courtyards.
Walking Route: Outdoor walking sessions will occur on pre-measured, paved urban streets
surrounding the nursing home, characterized by typical urban sights and sounds.
6.4 Exercise Protocol
The exercise regimen is standardized and supervised by certified fitness professionals to ensure
consistency and safety. The aerobic component for both groups consists of a supervised walking
program, designed to be matched as closely as possible on all key objective training parameters,
with the environmental context serving as the primary intended difference between groups.
Parameter
Specification
Frequency
5 sessions per week
Session Duration
60 minutes
Intensity
60-70% of heart rate reserve (HRR)
Mode
Group walking
Duration
10 weeks
6.5 Quality Assurance and Monitoring
To maximize internal validity, all exercise sessions for both groups will be delivered by the same
team of certified exercise coaches, who will adhere to a detailed, standardized protocol manual.
Exercise Intensity Monitoring: To standardize the dose of exercise and minimize inter-group

differences in exertion, real-time exercise intensity will be objectively monitored for every
participant using Polar H10 chest-worn heart rate sensors. Coaches will use this live feedback to
provide individual guidance, aiming to ensure participants in both groups exercise within the same
target heart rate zone.
Adherence Monitoring: Attendance at all scheduled sessions will be recorded. Participants
attending less than 80% of sessions (i.e., < 40 out of 50 sessions) will be considered
non-compliant but will be included in intention-to-treat analysis.
6.6 Concomitant Care
Participants in both groups will be instructed to maintain their usual dietary habits and not to
initiate any new exercise programs outside of the study intervention during the 10-week period.
7. OUTCOME MEASURES
A comprehensive battery of assessments will be administered to all participants at two time points:
prior to the initiation of the intervention at baseline (T0), and within one week following the
completion of the 10-week intervention (T1).
7.1 Primary Outcome Measures
Measure
Instrument/Test
Description
Unit/Score
Range
Body fat percentage
InBody 770
(multi-frequency BIA)
Measured under standardized
conditions
%
Body weight
InBody 770
Measured under standardized
conditions
kg
Body mass index
(BMI)
Calculated from weight
and height
Weight (kg) / Height (m²)
kg/m²
Lower-body
muscular endurance
30-second chair stand
test
Number of full stands from a
seated position in 30 seconds
number of stands
Upper-body
muscular strength
Handgrip dynamometer
Maximum grip strength of
dominant hand
kg
Standardized Measurement Conditions for BIA:
- Refrain from strenuous exercise for 24 hours
- Avoid alcohol and caffeine consumption for 12 hours
- Maintain normal fluid intake while avoiding excessive water consumption within 2 hours of
testing
- Empty bladder 30 minutes prior to measurement
- All follow-up assessments scheduled at the same time of day (±2 hours) as baseline
7.2 Secondary Outcome Measures

Construct
Instrument
Description
Score Range
Depressive
symptoms
Center for Epidemiologic
Studies Depression Scale
(CES-D)
20-item scale assessing
frequency of depressive
symptoms in past week
0-60 (higher =
worse)
State anxiety
State-Trait Anxiety
Inventory - State subscale
(STAI-S)
20-item scale measuring
transient anxious emotional
states
20-80 (higher =
worse)
Mental
health-related
quality of life
SF-36 Mental Component
Summary (MCS)
Aggregates dimensions of
mental health, vitality, social
functioning
Mean=50,
SD=10 (higher =
better)
Sleep quality
Pittsburgh Sleep Quality
Index (PSQI)
19-item instrument assessing
sleep quality over past month
0-21 (>5 = poor
sleep)
Perceived mastery
Pearlin-Schooler Mastery
Scale
7-item scale assessing
perceived control over life
forces
7-28 (higher =
better)
Psychometric Properties:
Scale
Cronbach's α (current study)
CES-D
0.92
STAI-S
0.89
SF-36 MCS
[to be reported]
PSQI
0.78
Mastery Scale
0.85
7.3 Other Measures
Demographic and Baseline Characteristics:
- Age
- Educational level
- Marital status
- Living situation
- Medical history
- Medication use
Adherence and Safety:
- Session attendance rate
- Adverse events (type, severity, relation to intervention)
8. STATISTICAL ANALYSIS PLAN
8.1 General Principles

All statistical analyses will be performed using IBM SPSS Statistics software, Version 26.0. A
two-tailed p-value of less than 0.05 will be chosen as the threshold for statistical significance for
all tests. Effect sizes will be reported using partial eta-squared (η²) for ANOVA models.
8.2 Data Screening and Preparation
- Normality: The normality of the distribution of all continuous outcome variables will be verified
using the Shapiro-Wilk test and visual inspection of Q-Q plots.
- Outliers: Extreme outliers (≥3 SD from mean) will be winsorized or, if clearly erroneous,
removed.
- Missing Data: Patterns of missing data will be examined. If data are missing completely at
random (MCAR), complete-case analysis will be performed. If missing data are related to
observed variables, multiple imputation will be considered.
8.3 Primary Analysis
The primary analysis for each outcome measure will consist of a 2 (Time: T0, T1) × 2 (Group:
NCE, CCE) repeated-measures analysis of variance (ANOVA). In this model:
- Main effect of Time: Indicates whether outcomes change significantly from baseline to
post-intervention across both groups.
- Main effect of Group: Indicates whether there are overall differences between groups regardless
of time.
- Time × Group interaction effect: Indicates whether the change over time differs significantly
between the two environments. This is the primary effect of interest for testing study hypotheses.
If a significant interaction is detected, simple effects analyses will be conducted to probe the
nature of the interaction further, examining:
- Within-group changes over time (paired t-tests or Wilcoxon signed-rank tests)
- Between-group differences at each time point (independent t-tests or Mann-Whitney U tests)
8.4 Analysis Populations
- Intention-to-Treat (ITT): All randomized participants will be included in the primary analysis,
regardless of adherence, analyzed according to their original group assignment.
- Per-Protocol (PP): A secondary analysis will be conducted including only participants who
completed at least 80% of scheduled sessions. Results from ITT and PP analyses will be
compared.
8.5 Subgroup Analyses
If sample size permits, exploratory subgroup analyses may be conducted based on:
- Baseline BMI category (overweight vs. obese)
- Baseline depression status (CES-D ≥16 vs. < 16)
These analyses are exploratory and will be interpreted cautiously.
8.6 Handling of Covariates
Baseline characteristics that differ between groups despite randomization (p < 0.10) will be

considered as covariates in ANCOVA models to adjust for potential confounding.
8.7 Statistical Power
Based on the sample size calculation, the study is adequately powered (80%) to detect a medium
effect size (f² = 0.25) for the Group × Time interaction in repeated-measures ANOVA.
9. ETHICAL CONSIDERATIONS
9.1 Ethical Approval
The study protocol received full ethical approval from the Institutional Review Board of Guilin
Tourism University scientific research (2024) No. 27. Any protocol amendments will be submitted
for ethical review and approval prior to implementation.
9.2 Declaration of Helsinki
This study will be conducted in strict accordance with the ethical principles outlined in the
Declaration of Helsinki.
9.3 Informed Consent
Written informed consent will be obtained from all participants prior to any study procedures. The
consent form will include:
- Purpose of the study
- Study procedures and duration
- Potential risks and benefits
- Confidentiality assurances
- Voluntary participation and right to withdraw
- Contact information for questions
9.4 Risks and Benefits
Potential Risks:
- Musculoskeletal injury during exercise (minimized by supervised sessions, warm-up/cool-down,
and progression monitoring)
- Fatigue or discomfort (participants can rest as needed)
- Minor skin irritation from heart rate monitor straps
Potential Benefits:
- Improved physical fitness and body composition
- Enhanced psychological well-being
- Social interaction and support
9.5 Risk Mitigation
- All sessions supervised by certified exercise professionals
- Emergency procedures in place at both locations
- Pre-exercise health screening
- Continuous monitoring of participant well-being
- Clear stopping criteria for adverse events

9.6 Withdrawal Criteria
Participants may be withdrawn from the study for:
- Voluntary withdrawal at any time
- Serious adverse event related to the intervention
- Development of exclusion criteria during the study
- Non-compliance (attendance < 40% despite encouragement)
10. DATA MANAGEMENT AND CONFIDENTIALITY
10.1 Data Collection
All data will be collected using standardized case report forms (CRFs) and entered into a secure
electronic database. Double data entry will be performed for a random 10% of cases to verify
accuracy.
10.2 Data Storage and Security
- All paper documents will be stored in locked filing cabinets in a secure office
- Electronic data will be stored on password-protected computers with encrypted hard drives
- Backups will be maintained on secure university servers
- Access to data will be restricted to authorized study personnel only
10.3 Confidentiality
- Participants will be identified only by a unique study ID number on all data collection forms
- No participant names or identifying information will be included in any publication or
presentation
- A master list linking participant names to IDs will be stored separately from data
10.4 Data Sharing
Individual participant data (IPD) will not be shared publicly due to ethical and privacy
considerations. Although the data are de-identified, the combination of detailed demographic
information (e.g., age, BMI, sedentary status) and specific environmental exposure (Yangshuo
tourism setting) could potentially allow for the re-identification of participants in this small cohort
study (N=50). Furthermore, the informed consent obtained from participants did not include
provisions for public data sharing. De-identified and aggregated summary data supporting the
findings of this study will be available from the corresponding author upon reasonable request.
11. DISSEMINATION POLICY
11.1 Publication Plan
Results of this study will be disseminated through:
- Peer-reviewed journal publications
- Presentations at scientific conferences
- Summary reports for participants
- ClinicalTrials.gov results submission
11.2 Authorship Criteria
Authorship on resulting publications will be determined according to the International Committee
of Medical Journal Editors (ICMJE) guidelines: substantial contributions to conception/design,
acquisition of data, or analysis/interpretation; drafting or revising the manuscript; final approval;

and agreement to be accountable for all aspects of the work.
11.3 ClinicalTrials.gov Registration
This study will be registered on ClinicalTrials.gov prior to participant enrollment. Results will be
submitted to ClinicalTrials.gov within one year of study completion.

Informed Consent Form for Experiment
Dear Experimental Participant: Thank you for participating in our experimental project.
Before you participate, please ensure that you have carefully read and understood the contents of
the following informed consent form. This informed consent form will detail the purpose, process,
potential risks, and your rights of the experiment.
Experimental Objective: This experiment aims to investigate the correlation between a tourist
attraction and weight loss. Experimental Procedure: Before the experiment begins, we will provide
you with detailed instructions and the experimental process. You will complete the assigned tasks
at the designated location and cooperate with us in collecting data and making records.
Compensation and Risks: Expenses incurred for transportation, catering, etc. due to research
needs can be reimbursed with receipts. This study has been approved by the ethics committee and
carries low risks. If you experience any discomfort, please inform the researcher immediately, and
we will take prompt measures to address it.
As a participant, you enjoy the following rights:
1. The right to independently decide whether to participate in the experiment and freely
choose to withdraw from it.
2. Obtain a comprehensive and clear explanation of the experimental purpose, process, risks,
and expected results.
3. The right to protect personal privacy and data.
4. Obtain feedback and summarize the experimental results.
Your data and privacy will be strictly protected and used solely for the purpose of this study.
We will properly store and process the data in accordance with relevant laws and regulations.
Please confirm your understanding and agreement to the above content by signing your name in
block letters in the box below this page, indicating your informed consent and voluntary
participation in this experiment.
If you have any questions about any part, please communicate with us before participating in
the experiment. Thank you for your cooperation and support!
Yours sincerely!