Structured Self-Talk and Wearable-Assisted Walking for Physical Activity and Function in Older Adults

NCT07767136 | Completed

• 1 other identifier: IRB115-029-BA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Physical Activity; Physical Function; Healthy Aging

Keywords

Structured Self-Talk; Wearable Technology; Walking Exercise; Community-Dwelling Older Adults; Physical Activity; Functional Performance; Muscle Strength; Body Composition

Outcome Measures

Primary Outcomes (6)

• Change in Time Spent in Moderate-to-Vigorous Physical Activity

  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.

  Baseline and 12 weeks

• Average Daily Step Count

  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.

  Baseline and 12 weeks

• Five-Times Sit-to-Stand

  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.

  Baseline and 12 weeks

• Handgrip Strength

  Upper-extremity muscle strength was assessed using dominant-hand grip strength. Strength was recorded in kilograms, with higher values indicating greater grip strength.

  Baseline and 12 weeks

• Timed Up and Go

  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.

  Baseline and 12 weeks

• Appendicular Skeletal Muscle Mass Index

  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.

  Baseline and 12 weeks

Secondary Outcomes (2)

• Exercise Self-Efficacy

  Baseline and 12 weeks

• Exercise Motivation / Behavioral Regulation

  Baseline and 12 weeks

Study Arms (3)

Integrated Intervention Group

EXPERIMENTAL

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.

Behavioral: Moderate-Intensity Walking Program; Device: Wearable Activity Device; Behavioral: Structured Self-Talk Training

Technology-Assisted Group

ACTIVE COMPARATOR

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.

Behavioral: Moderate-Intensity Walking Program; Device: Wearable Activity Device

Active Control Group

ACTIVE COMPARATOR

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.

Behavioral: Moderate-Intensity Walking Program

Interventions

Moderate-Intensity Walking Program BEHAVIORAL

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.

Active Control Group; Integrated Intervention Group; Technology-Assisted Group

Wearable Activity Device DEVICE

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.

Integrated Intervention Group; Technology-Assisted Group

Structured Self-Talk Training BEHAVIORAL

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.

Integrated Intervention Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CHENG-EN WU: lead

Study Sites (1)

Senior Community Activity Center

Taipei, 臺灣省, 244, Taiwan

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• CHENG-EN WU, phd

  National Taiwan College of Performing Arts

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 17, 2026
• Study Start: March 15, 2026
• Primary Completion: June 30, 2026
• Study Completion: June 30, 2026
• Last Updated: August 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)