Skip to main content
OpenTrials
Completed

NCT Number: NCT07767136

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Physical Activity Behavior Healthy Aging Motor Activity Physical Function

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Senior Community Activity Center

Taipei, 臺灣省, 244, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-

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

-

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Change in Time Spent in Moderate-to-Vigorous Physical Activity

    Time frame: Baseline and 12 weeks

    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.

  2. Average Daily Step Count

    Time frame: Baseline and 12 weeks

    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.

  3. Five-Times Sit-to-Stand

    Time frame: Baseline and 12 weeks

    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.

  4. Handgrip Strength

    Time frame: Baseline and 12 weeks

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

  5. Timed Up and Go

    Time frame: Baseline and 12 weeks

    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.

  6. Appendicular Skeletal Muscle Mass Index

    Time frame: Baseline and 12 weeks

    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.

Secondary outcomes

  1. Exercise Self-Efficacy

    Time frame: Baseline and 12 weeks

    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.

  2. Exercise Motivation / Behavioral Regulation

    Time frame: Baseline and 12 weeks

    Exercise motivation and internalization were assessed using a behavioral regulation in exercise questionnaire to evaluate the degree of autonomous motivation toward exercise.

Sponsors and collaborators

Lead sponsor

CHENG-EN WU

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 17, 2026
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.