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.
Studie Overzicht
Toestand
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
臺灣省
-
Taipei, 臺灣省, Taiwan, 244
- Senior Community Activity Center
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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:
-
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
|
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.
|
|
Actieve vergelijker: 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.
|
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.
|
|
Actieve vergelijker: 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.
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Time Spent in Moderate-to-Vigorous Physical Activity
Tijdsspanne: 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.
|
Baseline and 12 weeks
|
|
Average Daily Step Count
Tijdsspanne: 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.
|
Baseline and 12 weeks
|
|
Five-Times Sit-to-Stand
Tijdsspanne: 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.
|
Baseline and 12 weeks
|
|
Handgrip Strength
Tijdsspanne: 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.
|
Baseline and 12 weeks
|
|
Timed Up and Go
Tijdsspanne: 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.
|
Baseline and 12 weeks
|
|
Appendicular Skeletal Muscle Mass Index
Tijdsspanne: 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.
|
Baseline and 12 weeks
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Exercise Self-Efficacy
Tijdsspanne: 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.
|
Baseline and 12 weeks
|
|
Exercise Motivation / Behavioral Regulation
Tijdsspanne: 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.
|
Baseline and 12 weeks
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: CHENG-EN WU, phd, National Taiwan College of Performing Arts
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IRB115-029-BA
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .