ClinicalTrials.gg
CompletedNCT07767136Updated Aug 17, 2026

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

An interventional study of Moderate-Intensity Walking Program and Wearable Activity Device in Physical Activity, Physical Function and Healthy Aging, sponsored by CHENG-EN WU. Completed at 1 site in Taiwan. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-17.

Sponsored by CHENG-EN WU · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Mar 2026, registered Aug 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 149 studies in Motor Activity with a site in Taiwan — 24 open to participants now, 28 under way, none of them phase 3. Motor Activity · Taiwan.

Enrollment
78th of 136
60 · median 77
Started
2026
with 7 others
No phase
130 of 149
21 open now
Registered
146th of 149
by date

Among the 149 studies in Motor Activity with a site in Taiwan, this one is the 78th largest by enrollment of the 136 interventional ones that give a count, is one of 8 that started in 2026, is one of 130 with no phase, and was the 146th registered.

Motor Activity

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

Browse Motor Activity studies →

Open to participants now

24 of the 149 studies in Motor Activity with a site in Taiwan are open now. Recruiting first, the newest first:

19 more — sign in →

All 24 open studies →

A study can be open while its sites in Taiwan have not opened yet or have stopped. Only those recruiting at a site in Taiwan →

Who these studies take

Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.

This study: 65 Years and older · all sexes · healthy volunteers too.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Physical Activity
  • Physical Function
  • Healthy Aging

Browse trials for

Keywords

  • Structured Self-Talk
  • Wearable Technology
  • Walking Exercise
  • Community-Dwelling Older Adults
  • Physical Activity
  • Functional Performance
  • Muscle Strength
  • Body Composition
04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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+).

(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 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:

-

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • 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.

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

  • 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.

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

  • 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.

    Behavioral: Moderate-Intensity Walking Program

Interventions

  • BehavioralModerate-Intensity Walking Program

    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.

  • DeviceWearable Activity 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.

  • BehavioralStructured Self-Talk Training

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and 12 weeks

  2. 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.

    Time frame: Baseline and 12 weeks

  3. 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.

    Time frame: Baseline and 12 weeks

  4. 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.

    Time frame: Baseline and 12 weeks

  5. 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.

    Time frame: Baseline and 12 weeks

  6. 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.

    Time frame: Baseline and 12 weeks

Secondary outcomes

  1. Exercise Self-Efficacy

    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.

    Time frame: Baseline and 12 weeks

  2. Exercise Motivation / Behavioral Regulation

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

    Time frame: Baseline and 12 weeks

07

Study locations

1 site
  • Senior Community Activity Center
    Taipei, 臺灣省 244, Taiwan
08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be made publicly available because the informed consent obtained for this study did not include unrestricted public sharing of individual-level participant data. De-identified aggregate data may be provided upon reasonable request, subject to applicable ethical and institutional requirements.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2026 to primary completion in Jun 2026, 3 months.

Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 3 months is below that.

Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 11, 2026
First posted
Aug 17, 2026
StartActual
Mar 15, 2026
Primary completionActual
Jun 30, 2026
CompletionActual
Jun 30, 2026
Last update
Aug 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07767136
Lead sponsor
CHENG-EN WU
Responsible party
CHENG-EN WU (Assistant Professor, National Taiwan College of Performing Arts) — Sponsor-investigator
First posted
Aug 17, 2026
Start date
Mar 15, 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026
Last update
Aug 17, 2026

Study contacts

CHENG-EN WU, phd
principal investigator · National Taiwan College of Performing Arts

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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