Conditions or Focus of Study: Cognitive Function Loneliness Aging Physical ActivityWAW-CogLonNCT07650292
Wearable-Assisted Walking for Cognitive Function and Loneliness in Older Adults
A study testing Wearable-Assisted Walking Program in people with Conditions or Focus of Study: Cognitive Function Loneliness Aging Physical Activity, run by National Taiwan College of Performing Arts at 1 site in Taiwan.
Trial summary
Participants in the wearable-assisted walking group were asked to walk five days per week for approximately 30 minutes per session at moderate intensity. An Apple Watch was used to monitor daily steps, walking duration, and estimated energy expenditure. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Conditions or Focus of Study: Cognitive Function Loneliness Aging Physical Activity
- What is being tested?
- Wearable-Assisted Walking Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2026to 30 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age 65 years or older. Community-dwelling older adults recruited from community-based older adult programs in Taiwan.
- Ability to walk independently or with minimal assistance. Willingness to be randomized to either the wearable-assisted walking group or the usual-care control group.
- Willingness to wear a wearable device if assigned to the intervention group. Ability to understand the study procedures and complete the cognitive, psychological, and physical assessments.
- Provision of written informed consent before enrollment and baseline assessment.
Who cannot join
- Severe cardiovascular disease. Recent fracture or surgery. Severe neurological disorders. Severe cognitive impairment that precluded completion of study assessments. Medical contraindications to moderate-intensity walking. Current enrollment in other structured exercise or rehabilitation programs during the study period.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan College of Performing Arts
New Taipei City, 251301
About this study
Official title: Effects of a Wearable-Assisted Walking Program on Longitudinal Trajectories of Cognitive Function and Loneliness in Older Adults: A Randomized Controlled Trial
Participants in the wearable-assisted walking group were asked to walk five days per week for approximately 30 minutes per session at moderate intensity. An Apple Watch was used to monitor daily steps, walking duration, and estimated energy expenditure. Participants also received weekly feedback to support adherence to the walking program. Participants in the usual-care control group were asked to maintain their usual daily activities and not begin any new structured exercise program during the study period.
Cognitive function was measured using the Montreal Cognitive Assessment, and loneliness was measured using the 8-item UCLA Loneliness Scale. Assessments were conducted at baseline and at weeks 4, 8, and 12. The study also explored whether baseline muscle mass and functional mobility were associated with changes in cognitive function and loneliness over time.
Read the detailed description
This randomized controlled trial examined longitudinal changes in cognitive function and loneliness during a 12-week wearable-assisted walking intervention. The intervention combined regular moderate-intensity walking with wearable-device monitoring and weekly feedback. The control group received usual care and maintained their normal daily activities.
The primary outcome was cognitive function, measured using the Montreal Cognitive Assessment. The secondary psychosocial outcome was loneliness, measured using the 8-item UCLA Loneliness Scale. Outcomes were assessed at four time points: baseline, week 4, week 8, and week 12. Baseline appendicular skeletal muscle mass index and timed up-and-go performance were also assessed to examine whether muscle health and functional mobility were associated with individual differences in outcome trajectories.
- Being tested
- Wearable-Assisted Walking Program
- Keywords
- Conditions or Focus of Study:, Cognitive Function, Loneliness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable-Assisted Walking ProgramBehavioural
The intervention consisted of a 12-week moderate-intensity walking program supported by a commercially available wearable device. Participants were instructed to walk five days per week for approximately 30 minutes per session. Walking intensity was guided by a rating of perceived exertion of 11-13. An Apple Watch was used to record daily step counts, walking duration, and estimated caloric expenditure. Weekly feedback was provided through the LINE messaging application and face-to-face check-ins to support self-monitoring, reinforce walking goals, and monitor adherence.
| Study group | Role | What they receive |
|---|---|---|
| Wearable-Assisted Walking Group | Experimental | Participants assigned to this group received a 12-week wearable-assisted walking intervention. They were instructed to walk five days per week, with each session lasting approximately 30 minutes at moderate intensity. A commercially available Apple Watch was used to monitor daily step counts, walking duration, and estimated caloric expenditure. Weekly feedback was provided through the LINE messaging application and face-to-face check-ins to support self-monitoring, reinforce walking goals, and monitor adherence. Receives: Behavioral: Wearable-Assisted Walking Program |
| Usual-Care Control Group | No intervention | Participants assigned to this group were instructed to maintain their routine daily activities and typical lifestyle throughout the 12-week study period. They were asked not to initiate any new structured exercise or rehabilitation program during the study period. They did not receive wearable devices, structured walking prescriptions, or weekly activity feedback. |
| Behavioral | Experimental | The intervention consisted of a 12-week moderate-intensity walking program supported by a commercially available wearable device. Participants were instructed to walk five days per week for approximately 30 minutes per session. Walking intensity was guided by a rating of perceived exertion of 11-13. An Apple Watch was used to record daily step counts, walking duration, and estimated caloric expenditure. Weekly feedback was provided through the LINE messaging application and face-to-face check-ins to support self-monitoring, reinforce walking goals, and monitor adherence. Receives: Behavioral: Wearable-Assisted Walking Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cognitive Function Assessed by the Montreal Cognitive Assessment
Cognitive function was assessed using the Montreal Cognitive Assessment (MoCA), a brief screening tool that evaluates multiple cognitive domains, including visuospatial ability, executive function, attention, memory, language, abstraction, and orientation. Total scores range from 0 to 30, with higher scores indicating better cognitive performance.
Measured: Baseline, week 4, week 8, and week 12
Secondary outcomes (2)
Change in Loneliness Assessed by the 8-item UCLA Loneliness Scale
Loneliness was assessed using the 8-item UCLA Loneliness Scale (UCLA-8), which measures subjective feelings of loneliness and perceived social disconnection. Items are rated on a 4-point Likert-type scale, with higher total scores indicating greater loneliness.
Measured: Baseline, week 4, week 8, and week 12
Secondary Outcome Measure
Loneliness was assessed using the 8-item UCLA Loneliness Scale (UCLA-8), which measures subjective feelings of loneliness and perceived social disconnection. Items are rated on a 4-point Likert-type scale, with higher total scores indicating greater loneliness.
Measured: Baseline, week 4, week 8, and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start1 Jan 2026
- Primary completion30 May 2026
- Study completion30 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conditions or Focus of Study: Cognitive Function Loneliness Aging Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned in a 1:1 ratio to either a wearable-assisted walking intervention group or a usual-care control group. The intervention lasted 12 weeks, and outcomes were assessed at baseline, week 4, week 8, and week 12.
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan College of Performing Arts
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHENG-EN WU, National Taiwan College of Performing Arts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07650292
- Sponsor's protocol ID
- IRB115-029-B
- Other IDs
- IRB115-029-B
- Acronym
- WAW-CogLon
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan to Share IPD: Yes IPD Sharing Plan Description: Deidentified individual participant data that underlie the results reported in this study may be made available from the corresponding investigator upon reasonable request. Data sharing will be considered after review of the scientific purpose of the request and approval by the investigator, subject to applicable ethical and privacy regulations. IPD Sharing Supporting Information Type: Study Protocol Statistical Analysis Plan Time Frame: Data may be available beginning 6 months after publication of the main study results and for 3 years thereafter. Access Criteria: Researchers who provide a methodologically sound proposal may request access to deidentified data for academic and non-commercial research purposes. Requests should be directed to the corresponding investigator. Data will be shared only after approval of the request and, where applicable, completion of a data use agreement. URL: Leave blank
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Wearable-Assisted Walking Program on Longitudinal Trajectories of Cognitive Function and Loneliness in Older Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07650292
- Acronym / sponsor ID
- WAW-CogLon / IRB115-029-B
- Keywords
- Conditions or Focus of Study:, Cognitive Function, Loneliness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- National Taiwan College of Performing ArtsUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Participants in the wearable-assisted walking group were asked to walk five days per week for approximately 30 minutes per session at moderate intensity. An Apple Watch was used to monitor daily steps, walking duration, and estimated energy expenditure. Participants also received weekly feedback to support adherence to the walking program. Participants in the usual-care control group were asked to maintain their usual daily activities and not begin any new structured exercise program during the study period.
Cognitive function was measured using the Montreal Cognitive Assessment, and loneliness was measured using the 8-item UCLA Loneliness Scale. Assessments were conducted at baseline and at weeks 4, 8, and 12. The study also explored whether baseline muscle mass and functional mobility were associated with changes in cognitive function and loneliness over time.
Detailed description
This randomized controlled trial examined longitudinal changes in cognitive function and loneliness during a 12-week wearable-assisted walking intervention. The intervention combined regular moderate-intensity walking with wearable-device monitoring and weekly feedback. The control group received usual care and maintained their normal daily activities.
The primary outcome was cognitive function, measured using the Montreal Cognitive Assessment. The secondary psychosocial outcome was loneliness, measured using the 8-item UCLA Loneliness Scale. Outcomes were assessed at four time points: baseline, week 4, week 8, and week 12. Baseline appendicular skeletal muscle mass index and timed up-and-go performance were also assessed to examine whether muscle health and functional mobility were associated with individual differences in outcome trajectories.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants were randomly assigned in a 1:1 ratio to either a wearable-assisted walking intervention group or a usual-care control group. The intervention lasted 12 weeks, and outcomes were assessed at baseline, week 4, week 8, and week 12.
| Arm | Type | Receives |
|---|---|---|
| Wearable-Assisted Walking Group | Experimental | Behavioral: Wearable-Assisted Walking ProgramParticipants assigned to this group received a 12-week wearable-assisted walking intervention. They were instructed to walk five days per week, with each session lasting approximately 30 minutes at moderate intensity. A commercially available Apple Watch was used to monitor daily step counts, walking duration, and estimated caloric expenditure. Weekly feedback was provided through the LINE messaging application and face-to-face check-ins to support self-monitoring, reinforce walking goals, and monitor adherence. |
| Usual-Care Control Group | No intervention | –Participants assigned to this group were instructed to maintain their routine daily activities and typical lifestyle throughout the 12-week study period. They were asked not to initiate any new structured exercise or rehabilitation program during the study period. They did not receive wearable devices, structured walking prescriptions, or weekly activity feedback. |
| Behavioral | Experimental | Behavioral: Wearable-Assisted Walking ProgramThe intervention consisted of a 12-week moderate-intensity walking program supported by a commercially available wearable device. Participants were instructed to walk five days per week for approximately 30 minutes per session. Walking intensity was guided by a rating of perceived exertion of 11-13. An Apple Watch was used to record daily step counts, walking duration, and estimated caloric expenditure. Weekly feedback was provided through the LINE messaging application and face-to-face check-ins to support self-monitoring, reinforce walking goals, and monitor adherence. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age 65 years or older. Community-dwelling older adults recruited from community-based older adult programs in Taiwan.
- Ability to walk independently or with minimal assistance. Willingness to be randomized to either the wearable-assisted walking group or the usual-care control group.
- Willingness to wear a wearable device if assigned to the intervention group. Ability to understand the study procedures and complete the cognitive, psychological, and physical assessments.
- Provision of written informed consent before enrollment and baseline assessment.
Key exclusion criteria (1 listed)
- Severe cardiovascular disease. Recent fracture or surgery. Severe neurological disorders. Severe cognitive impairment that precluded completion of study assessments. Medical contraindications to moderate-intensity walking. Current enrollment in other structured exercise or rehabilitation programs during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable-Assisted Walking ProgramThe intervention consisted of a 12-week moderate-intensity walking program supported by a commercially available wearable device. Participants were instructed to walk five days per week for approximately 30 minutes per session. Walking intensity was guided by a rating of perceived exertion of 11-13. An Apple Watch was used to record daily step counts, walking duration, and estimated caloric expenditure. Weekly feedback was provided through the LINE messaging application and face-to-face check-ins to support self-monitoring, reinforce walking goals, and monitor adherence. | Behavioural | Behavioral, Wearable-Assisted Walking Group |
Primary outcome
Change in Cognitive Function Assessed by the Montreal Cognitive Assessment
Time frame: Baseline, week 4, week 8, and week 12
Cognitive function was assessed using the Montreal Cognitive Assessment (MoCA), a brief screening tool that evaluates multiple cognitive domains, including visuospatial ability, executive function, attention, memory, language, abstraction, and orientation. Total scores range from 0 to 30, with higher scores indicating better cognitive performance.
2 secondary outcomes
Change in Loneliness Assessed by the 8-item UCLA Loneliness Scale
Time frame: Baseline, week 4, week 8, and week 12
Secondary Outcome Measure
Time frame: Baseline, week 4, week 8, and week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: Yes. Plan to Share IPD: Yes IPD Sharing Plan Description: Deidentified individual participant data that underlie the results reported in this study may be made available from the corresponding investigator upon reasonable request. Data sharing will be considered after review of the scientific purpose of the request and approval by the investigator, subject to applicable ethical and privacy regulations. IPD Sharing Supporting Information Type: Study Protocol Statistical Analysis Plan Time Frame: Data may be available beginning 6 months after publication of the main study results and for 3 years thereafter. Access Criteria: Researchers who provide a methodologically sound proposal may request access to deidentified data for academic and non-commercial research purposes. Requests should be directed to the corresponding investigator. Data will be shared only after approval of the request and, where applicable, completion of a data use agreement. URL: Leave blank
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable-Assisted Walking Program in people with Conditions or Focus of Study: Cognitive Function Loneliness Aging Physical Activity, run by National Taiwan College of Performing Arts at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cognitive Function Assessed by the Montreal Cognitive Assessment (time frame: Baseline, week 4, week 8, and week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.