- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07767136
Structured Self-Talk and Wearable-Assisted Walking for Physical Activity and Function in Older Adults
Effects of Integrating Self-Talk Strategies With Wearable Technology on Physical Activity, Functional Performance, and Psychological Determinants in Community-Dwelling Older Adults: A Randomized Controlled Trial
The goal of this randomized clinical trial was to examine whether adding structured self-talk to wearable-assisted walking could support physical activity and physical function in community-dwelling older adults. The study also examined whether wearable-assisted walking provided benefits compared with a walking program without wearable feedback.
Participants were randomly assigned to one of three groups for 12 weeks: (1) wearable-assisted walking combined with structured self-talk, (2) wearable-assisted walking without structured self-talk, or (3) a walking-only active control condition. All groups followed the same moderate-intensity walking schedule.
The main questions were whether wearable-assisted walking was associated with better physical activity and functional performance than walking alone, and whether adding structured self-talk provided additional benefits beyond wearable-assisted walking. Physical activity, functional performance, and other protocol-specified health-related measures were assessed before and after the intervention.
Study Overview
Status
Conditions
Detailed Description
This was a 12-week, three-arm, parallel-group randomized controlled trial conducted in community-dwelling older adults. Sixty participants were allocated in a 1:1:1 ratio to an integrated intervention group, a technology-assisted group, or an active control group.
All three groups followed the same moderate-intensity walking prescription consisting of three 30-minute sessions per week for 12 weeks, with exercise intensity guided by a rating of perceived exertion of 11-13. The integrated intervention group used a wearable activity device that provided real-time activity feedback and also received structured self-talk training. The self-talk component was designed to help participants use task-focused and motivational statements during walking and progressed from awareness and instruction to regulation and self-directed use over the intervention period.
The technology-assisted group followed the same walking prescription and used the same wearable activity device but did not receive structured self-talk training. The active control group followed the same walking prescription without wearable feedback or structured self-talk and recorded exercise participation using a paper-based log.
Assessments were conducted at baseline and after completion of the 12-week intervention. Outcome assessors were blinded to group allocation. The study was designed to distinguish the effects associated with wearable-assisted walking from any additional effects associated with adding structured self-talk.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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臺灣省
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Taipei, 臺灣省, Taiwan, 244
- Senior Community Activity Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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Inclusion Criteria:
Aged 65 years or older. Community-dwelling and independent in activities of daily living. Able to ambulate safely without physical assistance; use of a cane was permitted.
Cleared for participation in moderate-intensity physical activity using the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+).
Montreal Cognitive Assessment (MoCA) score of 24 or higher. Sufficient literacy and communication ability in Chinese to understand study instructions and complete study procedures.
Access to a smartphone and an internet connection. Able to independently perform basic smartphone and wearable-device operations, including charging the wearable device.
Willing to wear the study wearable device and comply with the intervention procedures.
Exclusion Criteria:
A medically treated fall within the previous 3 months. A major cardiovascular event within the previous 6 months. Lower-extremity surgery within the previous 6 months. Severe neuromuscular disease that could interfere with safe participation or outcome assessment.
Severe visual or auditory impairment that could interfere with communication or study assessments.
Use of medications known to substantially affect cognitive function or muscle performance.
Concurrent participation in another structured exercise or rehabilitation program.
A medical contraindication to moderate-intensity exercise, including unstable chronic medical conditions as determined by a healthcare professional.
Severe psychiatric disorder or cognitive impairment that could interfere with adherence to study procedures.
Exclusion Criteria:
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Integrated Intervention Group
Participants received a 12-week moderate-intensity walking program combined with wearable-based activity feedback and structured self-talk training.
Walking was prescribed three times per week for 30 minutes per session at a rating of perceived exertion of 11-13.
The wearable device provided real-time step feedback and haptic alerts.
Structured self-talk training was provided weekly and progressed through awareness, acquisition, regulation, and maintenance stages.
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Participants performed moderate-intensity walking three times per week for 30 minutes per session over 12 weeks.
Exercise intensity was prescribed at a rating of perceived exertion (RPE) of 11-13.
This standardized walking program was provided to participants in all three study groups.
A wrist-worn wearable activity device was used to provide real-time step feedback and haptic vibration alerts during the 12-week walking intervention.
The device was used as a behavioral feedback tool to support walking participation.
Data from the intervention wearable device were not used as the research outcome measure.
Participants received weekly structured self-talk training throughout the 12-week intervention.
The training was delivered by trained instructors and progressed through four stages: awareness, acquisition, regulation, and maintenance.
Participants were taught to use structured motivational and instructional self-talk during walking and in response to wearable-generated feedback.
Standardized scripts and fidelity checklists were used to support consistent intervention delivery.
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Active Comparator: Technology-Assisted Group
Participants received the same 12-week moderate-intensity walking program and used the same wearable device for real-time activity feedback but did not receive structured self-talk training.
Brief weekly contacts were limited to device operation, battery status, and wearing compliance and did not include psychological strategy training.
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Participants performed moderate-intensity walking three times per week for 30 minutes per session over 12 weeks.
Exercise intensity was prescribed at a rating of perceived exertion (RPE) of 11-13.
This standardized walking program was provided to participants in all three study groups.
A wrist-worn wearable activity device was used to provide real-time step feedback and haptic vibration alerts during the 12-week walking intervention.
The device was used as a behavioral feedback tool to support walking participation.
Data from the intervention wearable device were not used as the research outcome measure.
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|
Active Comparator: Active Control Group
Participants received the same 12-week moderate-intensity walking program without wearable-based activity feedback or structured self-talk training.
Participants recorded the date, duration, and rating of perceived exertion of each walking session using a paper-based exercise log.
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Participants performed moderate-intensity walking three times per week for 30 minutes per session over 12 weeks.
Exercise intensity was prescribed at a rating of perceived exertion (RPE) of 11-13.
This standardized walking program was provided to participants in all three study groups.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Time Spent in Moderate-to-Vigorous Physical Activity
Time Frame: Baseline and 12 weeks
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Time spent in moderate-to-vigorous physical activity was assessed using a research-grade ActiGraph triaxial accelerometer during 7-day monitoring periods at baseline and after the 12-week intervention.
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Baseline and 12 weeks
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Average Daily Step Count
Time Frame: Baseline and 12 weeks
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Average daily step count was measured using a research-grade ActiGraph triaxial accelerometer worn on the non-dominant wrist.
Daily steps were summarized across valid monitoring days at baseline and after the 12-week intervention.
Higher values indicate greater daily physical activity.
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Baseline and 12 weeks
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Five-Times Sit-to-Stand
Time Frame: Baseline and 12 weeks
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Lower-extremity functional performance was assessed using the five-times sit-to-stand test.
Completion time was recorded in seconds, with shorter times indicating better performance.
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Baseline and 12 weeks
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Handgrip Strength
Time Frame: Baseline and 12 weeks
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Upper-extremity muscle strength was assessed using dominant-hand grip strength.
Strength was recorded in kilograms, with higher values indicating greater grip strength.
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Baseline and 12 weeks
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Timed Up and Go
Time Frame: Baseline and 12 weeks
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Dynamic balance and mobility were assessed using the Timed Up and Go test.
Completion time was recorded in seconds, with shorter times indicating better performance.
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Baseline and 12 weeks
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Appendicular Skeletal Muscle Mass Index
Time Frame: Baseline and 12 weeks
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Appendicular skeletal muscle mass index (ASMI) was assessed using an InBody 370S bioelectrical impedance analyzer and calculated as appendicular skeletal muscle mass divided by height squared (kg/m²).
Higher values indicate greater appendicular muscle mass relative to height.
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Baseline and 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Exercise Self-Efficacy
Time Frame: Baseline and 12 weeks
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Exercise self-efficacy was assessed using the Exercise Self-Efficacy Scale (ESES), which evaluates confidence in continuing exercise under challenging situations.
Higher scores indicate greater exercise self-efficacy.
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Baseline and 12 weeks
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Exercise Motivation / Behavioral Regulation
Time Frame: Baseline and 12 weeks
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Exercise motivation and internalization were assessed using a behavioral regulation in exercise questionnaire to evaluate the degree of autonomous motivation toward exercise.
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Baseline and 12 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: CHENG-EN WU, phd, National Taiwan College of Performing Arts
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB115-029-BA
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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