Hypertension, Multimorbidity, Stroke, Type 2 Diabetes Mellitus (T2DM)
Conditions
Brief summary
This study is a cluster randomized controlled trial with a 2×2 factorial design conducted in community health centers in Kunshan, Harbin, Wuhan, Beijing 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.
Detailed description
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), Beijing 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.
Interventions
BEHAVIORALExercise Intervention
Participants will receive twice-weekly aerobic and balance training sessions, with medication compliance education.
BEHAVIORALCognitive Intervention
Participants will participate in twice-weekly structured cognitive training sessions, with medication compliance education.
Sponsors
Duke Kunshan University
Wuhan University
Harbin Medical University
Shanghai Jiao Tong University School of Medicine
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intrinsic Capacity (World Health Organization Integrated Care for Older People) | 24 months | Assessment of intrinsic capacity using the World Health Organization Integrated Care for Older People (WHO ICOPE) framework. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mobility | 24 months | measured by timed-up-and-go test, a simple and quick functional mobility test that requires the participants to stand up, walk 3 meters, turn, walk back, and sit down |
| Locomotion: SPPB (Short Physical Performance Battery) | 24 months | The Short Physical Performance Battery (SPPB) is a validated, performance-based tool designed to assess lower extremity function in older adults. It consists of three components: a balance test, a gait speed test, and a chair stand test. Each component is scored on a scale from 0 to 4, with a total score ranging from 0 (worst performance) to 12 (best performance). |
| Cognition | 24 months | Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA), a widely validated screening tool for mild cognitive impairment. The MoCA evaluates multiple cognitive domains, including attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The MoCA score ranges from 0 to 30, with higher scores indicating better cognitive function. A score of 26 or above is generally considered within the normal range. Assessments will be conducted at baseline and at regular intervals across the 24-month study period to track changes over time. |
| Psychological well-being | 24 months | Psychological well-being will be assessed using the Cornell Scale for Depression in Dementia (CSDD), a clinician-administered instrument specifically designed to assess signs of depression in individuals with cognitive impairment, including those with dementia. The CSDD incorporates information from both patient interviews and caregiver reports to increase the reliability of the assessment. The scale includes 19 items, each scored from 0 (absent) to 2 (severe), resulting in a total score ranging from 0 to 38. Higher scores indicate more severe depressive symptoms, reflecting poorer psychological well-being. A score of ≥12 suggests probable major depression, while scores between 8-11 indicate possible depression. CSDD assessments will be performed at baseline and repeated at regular intervals throughout the 24-month study period. |
| Vitality | 24 months | Vitality will be assessed using the Mini Nutritional Assessment (MNA), a validated screening and assessment tool designed to identify older adults at risk of malnutrition or undernutrition, which are closely associated with reduced physical vitality and frailty. The full MNA consists of 18 items, producing a total score ranging from 0 to 30. Higher scores indicate better nutritional status, reflecting greater vitality and overall health. A score of 24-30 indicates normal nutritional status. Scores 17-23.5 suggest risk of malnutrition. Scores \<17 indicate malnutrition. The MNA will be administered at baseline and at regular follow-ups over the 24-month study period to monitor changes in patients' nutritional status and associated vitality. |
| Medication Adherence | 24 months | measured using the 4-item Morisky Green Levine Scale-4 (MMAS-4). The 4-item Morisky Green Levine Medication Adherence Scale (MMAS-4), is a validated self-reported questionnaire that evaluates patients' behaviors related to medication-taking. The scale consists of 4 yes/no questions, with each "yes" answer scored as 1 and each "no" as 0. The total score ranges from 0 to 4, with higher scores indicating lower adherence. A score of 0 indicates high adherence. 1-2 indicates medium adherence. 3-4 indicates low adherence. |
| Physical Activity (MET-min/week) | 24 months | Measurement of physical activity levels in metabolic equivalent of task (MET) minutes per week. |
| Systolic Blood Pressure (SBP) | 24 months | Change in the systolic blood pressure. |
| Weight | 24 months | change in weight |
| Height | 24 months | change in height |
| Neck circumference | 24 months | participants' neck circumference |
| Mental Health | 24 months | The Geriatric Depression Scale - 15 item version (GDS-15) is a self-report questionnaire designed to screen for depression in older adults. It contains 15 yes/no questions that assess mood, motivation, energy levels, and outlook on life over the past week. Scores range from 0 to 15, with higher scores indicating more severe depressive symptoms, thus reflecting a worse outcome. Each depressive answer is scored as 1 point, and the total score is the sum of these points. Commonly used cut-off points are: 0-4 (no depression), 5-8 (mild depression), 9-11 (moderate depression), and 12-15 (severe depression). |
| Health related quality of life | 24 months | measured using EuroQol-5 Dimensions-5L (EQ5D-5L). EQ-5D-5L descriptive system comprises the following five dimensions, each describing a different aspect of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. For each domain, the total scores range from 0 (indicating no problem) to 5 (indicating unable to/extreme problems). In addition, the participants were required to assess how their health is today by write a number from 0 to 100 on the numbered scale. 100 means the best health the participant can image, 0 means the worst health the participant can image. |
| Lifestyle risk factors | 24 months | The factors include lack of exercise, alcohol, diet, obesity, and smoking, and will be collected through questionnaire. |
| Basic activities of daily living | 24 months | measured by the basic activities of daily living (ADL). The basic ADL include the following categories: Ambulating, Feeding, Dressing, Personal hygiene, Continence, and Toileting. The ADL score ranges from 0 to 12. Limitation in ADL was defined as being scored greater than 0 on ADL scales, i.e., having some or severe limitation in at least one ADL item. Higher scores mean a worse functional independence. |
| Instrumental activities of daily living | 24 months | measured by the Lawton Instrumental Activities of Daily Living (IADL) Scale to evaluate independent living skills. The scale measures eight domains of function, including food preparation, housekeeping, laundering. The IADL score ranges from 0 to 14. Limitation in IADL was defined as being scored greater than 0 on IADL scales, i.e., having some or severe limitation in at least one IADL item. Higher scores mean a worse functional independence. |
| Disability | 24 months | measured using modified Rankin Scale (ranged 0 (no symptom) to 5 severe disability) |
| Multimorbidity | 24 months | Assessed by determining whether participants had additional diseases diagnosed in the hospital, excluding stroke |
| Locomotion: Grip strength | 24 months | Grip strength (kilogram) will be estimated through the dynamometer (YuejianTM WL-1000, Nantong, China). Trained examiners will instruct people to hold the dynamometer and squeeze the handle for a few seconds. This study both measures right and left-hand grip strength twice in each hand. The grip strength will be recorded separately. If the average grip strength of both right and left hand of is all less than the criteria (man \< 30 kg, woman \< 20 kg), it is defined as weak grip strength. |
| Continuation of medication taking | 24 months | Measured by the total number of months during the 24-month follow-up period that the patient continuously takes the prescribed medication. |
| Healthcare Utilization: Hospital Visits | 24 months | The number of hospital visits (both inpatient and outpatient) will be measured during the 24-month follow-up period. This will include the total number of hospital admissions, along with any follow-up outpatient visits associated with hospital care. Unit of Measure: Number of hospital visits |
| Healthcare Utilization: Emergency Room Visits | 24 months | The number of emergency room visits will be assessed over the 24-month period. This includes any visits to the emergency room for acute health concerns or urgent care needs. Unit of Measure: Number of emergency room visits |
| Healthcare Utilization: Outpatient Visits | 24 months | The number of outpatient visits (excluding emergency room and inpatient visits) will be measured throughout the 24-month study period. This includes visits to primary care providers, specialists, and other outpatient services. Unit of Measure: Number of outpatient visits |
| Self-reported disease history (via questionnaire) | 24 months | Presence of chronic diseases reported by participants through a structured questionnaire. Unit of Measure: Count of documented diseases |
| Waist circumference | 24 months | Participants' waist circumference |
| Disease history based on medical insurance records | 24 months | Number and type of diagnosed chronic diseases retrieved from participants' medical insurance claims data. Unit of Measure: Count of documented diseases |
Countries
China
Outcome results
None listed