Clinical trial NCT06445868: Construction and Preliminary Application of COM-B Based Sedentary Behavioural Booster Intervention Programme for Elderly Stroke Patients
Official title: Construction and Preliminary Application of COM-B Based Sedentary Behavioural Booster Intervention Programme for Elderly Stroke Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: Harbin Medical University
Sponsor class: OTHER
Collaborators: name: Harbin Medical University
First posted: 2024-06-06
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Explore the application effect of the sedentary behaviour intervention program for elderly stroke patients based on the COM-B model.

Detailed description: The goal of this clinical trial is to text about in the application effect of the sedentary behaviour intervention program for elderly stroke patients based on the COM-B model. The main question it aims to answer are:

* Changes in sedentary behaviour in elderly stroke patients Participants will received a 12-week sedentary behaviour intervention programme.

Researchers will compare differences in sedentary behaviour between routine care control and intervention groups.

Eligibility criteria: Inclusion Criteria:

* Meet the diagnostic criteria for cerebral infarction and cerebral hemorrhage in the Diagnostic Points for Various Major Cerebrovascular Diseases in China 2019 issued by the Cerebrovascular Disease Group of the Neurology Branch of the Chinese Medical Association;
* Age ≥60 years;
* National Institute of Health stroke scale (NIHSS) score \<5 (i.e., mild stroke), stable vital signs, and able to cooperate with the survey;
* Total sedentary time ≥6 hours/day measured using the International Physical Activity Questionnaire;
* Resident for ≥6 months in the community residents;
* Patients or under the guidance of others can use WeChat.

Exclusion Criteria:

* Functional ambulation category scale (FAC) score \<2;
* serious myocardial infarction, cerebral hemorrhage and pulmonary embolism in the acute stage of the need to limit the activities of the situation;
* is participating in other physical activity or sedentary behavioral intervention programs;
* severe muscle weakness, fractures and other diseases resulting in limited physical activity;
* serious mental disorders such as schizophrenia or dementia resulting in severe cognitive impairment;
* speech and communication disorders.

Primary outcomes:
measure: sedentary time
timeFrame: baseline (T0), 12-week post-intervention (T1), and 8-week follow-up (T2).
measure: Social Support
timeFrame: baseline (T0), 12-week post-intervention (T1), and 8-week follow-up (T2).
measure: Depression
timeFrame: baseline (T0), 12-week post-intervention (T1), and 8-week follow-up (T2).
measure: Exercise Adherence
timeFrame: baseline (T0), 12-week post-intervention (T1), and 8-week follow-up (T2).
measure: Ability to perform activities of daily living
timeFrame: baseline (T0), 12-week post-intervention (T1), and 8-week follow-up (T2).
measure: 10 meter maximum walking speed
timeFrame: baseline (T0), 12-week post-intervention (T1), and 8-week follow-up (T2).
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: