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

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.

Study Overview

• Status: Completed
• Conditions: Stroke, Acute
• Intervention / Treatment: Other: early mobilization

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.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hsiao Lan Wang, University; Phone Number: 0955128963; Email: 105861@ntuh.gov.tw
• Study Contact Backup: Name: Hsiao Lan Wang, University; Phone Number: 62357 0223123456; Email: 105861@ntuh.gov.tw

Study Locations

• Taiwan
  • Taipei, Taiwan
    • National Taiwan University Hospital
  • Taipei county, Taiwan
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: early mobilization in stroke patients; 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.	Other: early mobilization; Patients will receive early mobilization measures within 24 to 48 hours after the onset of stroke.
No Intervention: usual care in stroke patients; Participants will receive routine rehabilitation once daily, consisting of 20 minutes of bed exercises, including both active and passive joint movements.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess changes in functional status	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.	Data were collected at three measurement time points: baseline, the fourth week, and the 12th week after stroke.
Assess changes in sychological distress	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.	Data were collected at three measurement time points: baseline, the fourth week, and the 12th week after stroke.
Assess changes in quality of life	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.	Data were collected at three measurement time points: baseline, the fourth week, and the 12th week after stroke.

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Hsiao Lan Wang, University, National Taiwan University Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2022
• Primary Completion (Actual): April 10, 2023
• Study Completion (Actual): April 10, 2023

Study Registration Dates

• First Submitted: April 24, 2022
• First Submitted That Met QC Criteria: May 15, 2022
• First Posted (Actual): May 19, 2022

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 14, 2024
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: stroke; early mobilization
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 202202035RINC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No