Community-Empowerment and Environmental Enrichment-based Co-management (CEEEC) Model and Mechanisms for Improving Health of Older Stroke Patients With Multimorbidity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

444 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-20

Study Completion Date

2027-06-20

Brief Summary

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This study is a cluster randomized controlled trial with a 2×2 factorial design conducted in community health centers in Kunshan, Harbin, Wuhan and Shanghai. It aims to evaluate the independent and combined effects of exercise and cognitive interventions on intrinsic capacity and related health outcomes among stroke survivors aged 60 years and older with hypertension or type 2 diabetes mellitus. Participants will receive either exercise training, cognitive training, combined training, or usual care over 12 months, followed by a 12-month follow-up. Findings will inform integrated health management strategies for older adults with multimorbidity.

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Detailed Description

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This study is a community-based cluster randomized controlled trial with a 2×2 factorial design, conducted in community health centers in Kunshan (Jiangsu), Wuhan (Hubei), Harbin (Heilongjiang), and Shanghai, China. A total of 480 stroke survivors aged 60 years and above with comorbid hypertension or type 2 diabetes mellitus will be recruited. Participants will be randomly assigned to one of four groups: exercise intervention only, cognitive intervention only, combined intervention, or control (usual care). The interventions, including aerobic-balance physical training and structured cognitive training, will be delivered twice weekly for 12 months, followed by a 12-month observational follow-up.

The primary outcome is intrinsic capacity (IC), assessed using the World Health Organization Integrated Care for Older People (WHO ICOPE) framework. Secondary outcomes include systolic blood pressure, quality of life (EuroQol 5-Dimension 5-Level, EQ-5D-5L), medication adherence, physical activity (Metabolic Equivalent of Task minutes per week, MET-min/week), and healthcare utilization. Data will be collected at baseline, 6, 12, and 24 months.

Intervention effects and trajectories over time will be analyzed using two-way analysis of variance (ANOVA), repeated measures ANOVA, and mixed-effects models. Implementation outcomes will be evaluated following the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. The study aims to generate evidence for integrated health management strategies for older adults with stroke and multimorbidity in urban China.

Conditions

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Hypertension Type 2 Diabetes Mellitus (T2DM) Multimorbidity Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Active Control

Participants in this arm will receive medication compliance education from the family doctor.

Group Type NO_INTERVENTION

No interventions assigned to this group

Physical Activity Only

Participants will receive twice-weekly aerobic and balance training sessions, with medication compliance education.

Group Type EXPERIMENTAL

Exercise Intervention

Intervention Type BEHAVIORAL

Participants will receive twice-weekly aerobic and balance training sessions, with medication compliance education.

Cognitive Training Only

Participants in this arm will participate in twice-weekly structured cognitive training sessions, with medication compliance education.

Group Type EXPERIMENTAL

Cognitive Intervention

Intervention Type BEHAVIORAL

Participants will participate in twice-weekly structured cognitive training sessions, with medication compliance education.

Combined Physical + Cognitive

Participants in this arm will receive both twice-weekly aerobic and balance training sessions and twice-weekly structured cognitive training sessions, with medication compliance education.

Group Type EXPERIMENTAL

Exercise Intervention

Intervention Type BEHAVIORAL

Participants will receive twice-weekly aerobic and balance training sessions, with medication compliance education.

Cognitive Intervention

Intervention Type BEHAVIORAL

Participants will participate in twice-weekly structured cognitive training sessions, with medication compliance education.

Interventions

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Exercise Intervention

Participants will receive twice-weekly aerobic and balance training sessions, with medication compliance education.

Intervention Type BEHAVIORAL

Cognitive Intervention

Participants will participate in twice-weekly structured cognitive training sessions, with medication compliance education.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Aged ≥60 years
* The doctor diagnosed it as a stroke and it is in a stable stage (the diagnosis time is not limited)
* Patients with concurrent hypertension and/or diabetes may also have other diseases at the same time
* Be able to participate in a community intervention lasting for six months
* Be informed and agree to participate in the research

Exclusion Criteria

* With the aid of a walking aid (not a wheelchair), it is also impossible to walk independently to the community service center.
* Lack basic communication skills and do not recognize Arabic numerals
* Suffering from life-threatening diseases, with a survival expectation of less than 6 months, etc.

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No