The Effects of Early Mobilization in Stroke Patients on Functional Status, Psychological Distress, and Quality of Life

Not Applicable

Completed

• Conditions: Stroke, Acute
• Interventions: Other: early mobilization

• Registration Number: NCT05381220
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

This study aims to investigate the effects of an early mobilization intervention in improving functional status, psychological distress, and quality of life in stroke patients. We hypothesize that this intervention method can significantly alleviate patient anxiety and depression, thereby promoting functional recovery and enhancing overall quality of life. Through this research, we hope to provide stroke patients with more effective exercise programs to help them regain health and well-being.

Detailed Description

This study employs an experimental design conducted on patients in the stroke unit of the hospital who are over 20 years old and have either ischemic or hemorrhagic stroke with stable vital signs post-stroke onset, limb muscle strength greater than 3 points, and good communication skills in Chinese and Taiwanese, or they can read Chinese. Eligible participants are divided into an experimental group and a control group. All participants receive standard stroke unit care, while the intervention group additionally undergoes a 3-day activity protocol. The primary outcomes are assessed at baseline and at 1, 4, and 12 weeks post-stroke. Finally, the study analyzes the effect of early intervention on improving the prognosis of stroke patients.

The data collected in this study, whether in paper form or electronically, will be documented on a computer. After completing the research report, any recordings and paper documents will be destroyed. Once the data is documented, identifiable patient information will be removed, and each record will be assigned a unique code, making individual data unidentifiable.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2022-04-14
• Study First Submitted: 2022-04-24
• Study First Submitted QC: 2022-05-15
• Study First Posted: 2022-05-19
• Status Verified: 2023-04
• Primary Completion: 2023-04-10
• Study Completion: 2023-04-10
• Last Update Submitted: 2024-04-14
• Last Update Posted: 2024-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• Must be over 20 years old.
• Patients diagnosed with infarct or hemorrhagic stroke 24 to 72 hours later. -Patients with stable vital signs, systolic blood pressure between 140- 220mmHg, heartbeat 40-130bpm, blood oxygen >92%.
• The muscle strength of the limbs is greater than 3 points.
• Can communicate in Chinese and Taiwanese.

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Exclusion Criteria

• Patients with severe mental illness, critically ill patients and cognitive dysfunction.
• Surgery patients, aphasia patients.
• NIHSS greater than 16 points for severe stroke

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
early mobilization in stroke patients	early mobilization	The first day is to elevate the head of the bed and sit for 5 minutes The second day is to elevate the head of the bed for 10 minutes and sit on the edge of the bed for 5 minutes.On the third day, sit on the edge of the bed for 10 minutes, get out of bed and stand for 10 minutes, and stand still for 5 to 15 minutes. The exercise duration will be adjusted according to the patient's condition, with each session lasting at least 25 minutes. The frequency of activities will be twice daily, for a duration of three days.

Primary Outcome Measures

Name	Time	Method
Assess changes in functional status	Data were collected at three measurement time points: baseline, the fourth week, and the 12th week after stroke.	Functional status was assessed by Barthel Activity Daily Index (BI) and modified Rankin scale (mRS) were applied to assess activities of daily life with stroke patients. The BI is consisting of 10 common activities of daily living activities. Eight of the ten items represent activities related to personal care; the remaining 2 are related to mobility. A total score out of 100; the higher the score, the greater the degree of functional independence. The mRS scale runs from 0-6, the score of 0 is no disability, 5 is disability requiring constant care for all needs, and 6 is death.
Assess changes in sychological distress	Data were collected at three measurement time points: baseline, the fourth week, and the 12th week after stroke.	Psychological distress was measured using the Hospital Anxiety and Depression Scale (HADS) scale. It consists of 14 items, which can be divided into two subscales of seven items each: the anxiety subscale (HADS-A) and the depression subscale (HADS-D). The total HADS score was ranged from 0 to 21. A score greater than or equal to 11 indicates that the patient has anxiety or depression.
Assess changes in quality of life	Data were collected at three measurement time points: baseline, the fourth week, and the 12th week after stroke.	The Stroke Impact Scale (SIS) assesses other dimensions of health related quality of life: emotion, communication, memory and thinking, and social role function, The total SIS score was ranged from 16 to 90. The higher scores mean a better outcome.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan