StrokeNCT06445868
Construction and Preliminary Application of COM-B Based Sedentary Behavioural Booster Intervention Programme for Elderly Stroke Patients
A study testing Sedentary behaviour intervention in people with Stroke, run by Liu Shuxian.
Trial summary
Explore the application effect of the sedentary behaviour intervention program for elderly stroke patients based on the COM-B model. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Sedentary behaviour intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Dec 2024
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Explore the application effect of the sedentary behaviour intervention program for elderly stroke patients based on the COM-B model.
Read the 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.
- Conditions
- Stroke
- Being tested
- Sedentary behaviour intervention
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sedentary behaviour interventionOther
COM-B-based development of specific sedentary behavioral interventions to reduce sedentary time, promote healthy activity, and improve quality of life in older stroke patients
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Knowledge (information support, changing health attitudes); Motivation (motivation to change sedentary behaviour and improve exercise compliance); Capacity (development of exercise plans to improve sedentary behaviour change); Opportunities (increasing the timing of exercise and creating opportunities for sedentary behaviour change); Behaviour (monitoring and reinforcing sedentary behaviour change) Receives: Other: Sedentary behaviour intervention |
| control group | No intervention | Routine nursing education |
What is being measured
The primary outcome is the main question the study is designed to answer.
sedentary time
International Physical Activity Questionnaire (IPAQ) Sedentary behavior and physical activity levels were assessed using the International Physical Activity Questionnaire (IPAQ), which was developed by the International Physical Activity Measurement Working Group (IPAMWG) in 2001, with the coefficients for sedentary behavior and validity scale correlation coefficients of 0.887 and 0.760 for sedentary behavior and 0.779 and 0.718 for physical activity, respectively. In this questionnaire, the metabolic equivalent of walking was 3.3, moderate activity intensity was 4.0, and high intensity activity was 8.0. The formula for calculating sedentary time was: sedentary time per day = (weekday sitting time x 5 + weekend sitting time x 2)/7
Measured: baseline (T0), 12-week post-intervention (T1), and 8-week follow-up (T2).
Social Support
Social Support Rating Scale (SSRS) This scale is mainly used for the evaluation of individual social support status, with 10 entries, including 3 dimensions of subjective support, objective support and utilization of support. The scoring method is the sum of the scores of each entry, and the higher the score, the higher the level of social support. The scale reliability coefficient was 0.896.
Measured: baseline (T0), 12-week post-intervention (T1), and 8-week follow-up (T2).
Depression
The Self-Rating Depression Scale (SDS) Self-Rating Depression Scale (SDS) is a 20-item self-rating scale, with scores of 1, 2, 3, and 4 for each item, and the sum of the scores of all items ranging from 53-62 indicating mild depression; 63-72 indicating moderate depression; and more than 72 indicating severe depression. The higher the total score, the more severe the depression. The Cronbach's alpha coefficient of the scale was 0.920.
Measured: baseline (T0), 12-week post-intervention (T1), and 8-week follow-up (T2).
Exercise Adherence
Functional Exercise Adherence Scale for Stroke Patients (Questionnaire of Exercise Adherence, EAQ) The EAQ was developed by Beilei Lin in 2013 to assess patients' adherence to rehabilitation exercises. It contains 14 entries divided into 3 dimensions (physical participation in exercise, exercise effect monitoring and active seeking of exercise advice adherence), with each entry scored on a scale of 1 to 4. The total score of the scale ranges from 14 to 56, and the adherence index is the percentage value of the patient's measured score to the maximum score of the scale (56). The level of patient adherence was judged according to the adherence index: ≤50% = low level, 50% to 75% = medium level, and ≥75% = high level. The scale had good content validity (0.95), structural validity and validity scale validity, and high retest reliability (ICC: 0.778-0.850) and internal consistency (Cronbach's alpha coefficient: 0.923).
Measured: baseline (T0), 12-week post-intervention (T1), and 8-week follow-up (T2).
Ability to perform activities of daily living
Modified Barthel Index Scale (MBI) The MBI scale was made in 1989 by Canadian scholars Shah and Vanchay, who subdivided the BI scale into 5 levels.The MBI scale[117] contains 10 basic activities of daily living (ADLs) such as dressing, grooming, eating, bathing, walking, transferring from bed and chair to toilet, etc., and is divided into 5 levels according to the degree of independence from 1-5, with the lowest being 1 and the highest being 5, which is determined and scored out of 100 points according to the completion of the patient's performance. The higher the score, the better the ability to perform activities of daily living.
Measured: baseline (T0), 12-week post-intervention (T1), and 8-week follow-up (T2).
10 meter maximum walking speed
10 meter maximum walking speed (10 mMWS) The 10m maximum walking speed can reflect the patient's walking speed and walking functional status. First, a 16-meter straight line is drawn on a smooth surface, with markings at 3 and 13 meters. Let the patient walk along this straight line, assistive devices can be used, the timing starts when they reach 3 meters and ends at 13 meters, the time needed is recorded and the step speed is calculated at the same time, in this study, the test was done 3 times and the average value was taken, the faster the speed represents the better the walking ability and the slower the worse.
Measured: baseline (T0), 12-week post-intervention (T1), and 8-week follow-up (T2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study startJul 2024 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liu Shuxian
- Sponsor type
- University, hospital or other
- Collaborators
- Harbin Medical University
- Responsible party
- Sponsor-investigator, Liu Shuxian, Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06445868
- Sponsor's protocol ID
- HMUDQ20231116221
- Status last verified
- Jun 2024
- First submitted
- 1 Jun 2024
- Last updated
- 6 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Preliminary Application of COM-B Based Sedentary Behavioural Booster Intervention Programme for Elderly Stroke Patients
- ClinicalTrials.gov ID
- NCT06445868
- Acronym / sponsor ID
- HMUDQ20231116221
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Liu ShuxianUniversity, hospital or other
- Collaborators
- Harbin Medical University
- Study start
- Jul 2024 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 6 Jun 2024 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: Sedentary behaviour interventionKnowledge (information support, changing health attitudes); Motivation (motivation to change sedentary behaviour and improve exercise compliance); Capacity (development of exercise plans to improve sedentary behaviour change); Opportunities (increasing the timing of exercise and creating opportunities for sedentary behaviour change); Behaviour (monitoring and reinforcing sedentary behaviour change) |
| control group | No intervention | –Routine nursing education |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
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 |
|---|---|---|
| Sedentary behaviour interventionCOM-B-based development of specific sedentary behavioral interventions to reduce sedentary time, promote healthy activity, and improve quality of life in older stroke patients | Other | intervention group |
Primary outcome
sedentary time
Time frame: baseline (T0), 12-week post-intervention (T1), and 8-week follow-up (T2).
International Physical Activity Questionnaire (IPAQ) Sedentary behavior and physical activity levels were assessed using the International Physical Activity Questionnaire (IPAQ), which was developed by the International Physical Activity Measurement Working Group (IPAMWG) in 2001, with the coefficients for sedentary behavior and validity scale correlation coefficients of 0.887 and 0.760 for sedentary behavior and 0.779 and 0.718 for physical activity, respectively. In this questionnaire, the metabolic equivalent of walking was 3.3, moderate activity intensity was 4.0, and high intensity activity was 8.0. The formula for calculating sedentary time was: sedentary time per day = (weekday sitting time x 5 + weekend sitting time x 2)/7
Social Support
Time frame: baseline (T0), 12-week post-intervention (T1), and 8-week follow-up (T2).
Social Support Rating Scale (SSRS) This scale is mainly used for the evaluation of individual social support status, with 10 entries, including 3 dimensions of subjective support, objective support and utilization of support. The scoring method is the sum of the scores of each entry, and the higher the score, the higher the level of social support. The scale reliability coefficient was 0.896.
Depression
Time frame: baseline (T0), 12-week post-intervention (T1), and 8-week follow-up (T2).
The Self-Rating Depression Scale (SDS) Self-Rating Depression Scale (SDS) is a 20-item self-rating scale, with scores of 1, 2, 3, and 4 for each item, and the sum of the scores of all items ranging from 53-62 indicating mild depression; 63-72 indicating moderate depression; and more than 72 indicating severe depression. The higher the total score, the more severe the depression. The Cronbach's alpha coefficient of the scale was 0.920.
Exercise Adherence
Time frame: baseline (T0), 12-week post-intervention (T1), and 8-week follow-up (T2).
Functional Exercise Adherence Scale for Stroke Patients (Questionnaire of Exercise Adherence, EAQ) The EAQ was developed by Beilei Lin in 2013 to assess patients' adherence to rehabilitation exercises. It contains 14 entries divided into 3 dimensions (physical participation in exercise, exercise effect monitoring and active seeking of exercise advice adherence), with each entry scored on a scale of 1 to 4. The total score of the scale ranges from 14 to 56, and the adherence index is the percentage value of the patient's measured score to the maximum score of the scale (56). The level of patient adherence was judged according to the adherence index: ≤50% = low level, 50% to 75% = medium level, and ≥75% = high level. The scale had good content validity (0.95), structural validity and validity scale validity, and high retest reliability (ICC: 0.778-0.850) and internal consistency (Cronbach's alpha coefficient: 0.923).
Ability to perform activities of daily living
Time frame: baseline (T0), 12-week post-intervention (T1), and 8-week follow-up (T2).
Modified Barthel Index Scale (MBI) The MBI scale was made in 1989 by Canadian scholars Shah and Vanchay, who subdivided the BI scale into 5 levels.The MBI scale[117] contains 10 basic activities of daily living (ADLs) such as dressing, grooming, eating, bathing, walking, transferring from bed and chair to toilet, etc., and is divided into 5 levels according to the degree of independence from 1-5, with the lowest being 1 and the highest being 5, which is determined and scored out of 100 points according to the completion of the patient's performance. The higher the score, the better the ability to perform activities of daily living.
10 meter maximum walking speed
Time frame: baseline (T0), 12-week post-intervention (T1), and 8-week follow-up (T2).
10 meter maximum walking speed (10 mMWS) The 10m maximum walking speed can reflect the patient's walking speed and walking functional status. First, a 16-meter straight line is drawn on a smooth surface, with markings at 3 and 13 meters. Let the patient walk along this straight line, assistive devices can be used, the timing starts when they reach 3 meters and ends at 13 meters, the time needed is recorded and the step speed is calculated at the same time, in this study, the test was done 3 times and the average value was taken, the faster the speed represents the better the walking ability and the slower the worse.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Sedentary behaviour intervention in people with Stroke, run by Liu Shuxian.
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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact shuxian Liu (18238009052, 18238009052@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sedentary time (time frame: baseline (T0), 12-week post-intervention (T1), and 8-week follow-up (T2).). The study lists 6 primary outcomes in all. 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 6 Jun 2024.