Smartwatch-Guided Secondary Prevention After Stroke

NCT07640360 | Not Yet Recruiting

• 1 other identifier: 29BRC23.0208
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

After a first stroke or transient ischemic attack (TIA), the risk of recurrence is high in the weeks and months following the initial event. There are several modifiable risk factors that can reduce this risk, such as blood pressure, diet, physical activity, and smoking. Many stroke patients (NIHSS \< 5) have a low daily step count during the early recovery period, despite a good functional prognosis. Active smartwatches provide real-time feedback, track progress, and set personalized walking goals, thereby boosting motivation and adherence to physical activity recommendations. The combination of advice provided by nurses and active behavioral coaching supported by a smartwatch, compared to passive monitoring, could significantly increase daily step counts over a 12-week period. The results of this research will help guide future large-scale secondary prevention strategies integrating digital health and structured nursing support.

Conditions

Stroke; Transient Ischemic Attack

Keywords

SMARTWATCH

Outcome Measures

Primary Outcomes (1)

• To determine whether the addition of an active smartwatch providing structured feedback to a nurse-led activity program produces a significantly greater increase in daily step count over 12 weeks compared with the same program paired with a passive smart

  Difference in steps/day at 12 weeks between both arms (average of the final 14 valid days) (target Δ ≥ 1500)

  Week 12

Secondary Outcomes (15)

• To evaluate feasibility to smartwatch wear

  Week 6 and Week 12

• To evaluate adherence to smartwatch wear

  Week 6 and Week 12

• To evaluate acceptability of digital feedback.

  Week 6 and Week 12

• To assess the impact of active smartwatch feedback on sedentary time.

  day 1 to week 12

• To assess the impact of active smartwatch feedback on gait-related activity patterns.

  day 1 to week 12

Study Arms (2)

"Passive" Smartwatch arm

NO INTERVENTION

* Smartwatch collects step and wear-time data passively. * Participants do not receive daily goals, structured prompts, or real-time feedback regarding progress. * Nurses provide general advice but do not review detailed step graphs. * Data used only for endpoint assessment at M3.

"Active" Smartwatch arm

EXPERIMENTAL

* Smartwatch provides real-time structured feedback, including daily step counts, a visual progress bar, and automated prompts. * Research technician review step graphs during tele-visits, highlighting high/low activity days, barriers, and facilitators personalized daily step goals (twice a week) defined as +15-20% above baseline will be adjusted by Research technician based on progress and symptoms. * Goals increased by +10% if ≥4/7 days meet targets; maintained or decreased if symptomatic or not meeting goals.

Other: Smartwatch-Guided Secondary Prevention after Stroke

Interventions

Smartwatch-Guided Secondary Prevention after Stroke OTHER

Setting daily walking goals, assessing obstacles Regular phone calls (twice a week) to review progress, adjust goals, and provide support

"Active" Smartwatch arm

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≤ 40-75
• Patients with recent minor ischemic stroke or TIA, initial NIHSS ≤5 (\< 30 days)
• mRS ≤2 before stroke and on discharge
• Patient with Wifi access (for data transmission)
• Able to understand smartwatch instructions
• Written informed consent
• Ambulatory ≥10 meters without assistance and without walking aid
• Expected to live at home during the study period.

You may not qualify if:

• Patients with transient neurological deficits resolving within one hour and normal brain imaging will be excluded
• Not affiliated to social security
• Patient under legal protection or deprived of liberty by a judicial or administrative decision
• Patient whose follow-up will be impossible
• Cognitive impairment interfering with participation (e.g., MoCA \<20).
• Unstable cardiac conditions preventing walking goals.
• Major visual or upper limb impairment preventing use of the smartwatch.
• Life expectancy \<1 year.
• Already highly active (\>10,000 steps/day, or about 1.5 hours of walking).
• Participation in competing interventional trials.

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHU Brest

Brest, 29200, France

Location

MeSH Terms

Conditions

Stroke; Ischemic Attack, Transient

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia

Central Study Contacts

Serge TIMSIT Pr, Neurologist

CONTACT

+33298147349; serge.timsit@chu-brest.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * A prospective, randomized, parallel-group, superiority trial with 1:1 allocation.. * Randomization: Computer-generated, stratified by baseline steps (\<4,000 vs ≥4,000) * Blinding: Due to the behavioral nature of the intervention, participants and nurses cannot be blinded. * Outcome assessors will remain blinded to treatment allocation. * A CONSORT flowchart will document the passage from screening → randomization → follow-up. → end of study * Baseline (B), weeks (W) 12: o Face-to-face consultation: B and W12: Nurse + Clinical study technician for all patients * W6: phone call to provide feedback and get the information * Behavior multicomponent strategies (2X/week) for the active arm (Clinical study technician watch or phone incentive/prompt)

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 10, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations

FR (1)