Vivifrail Program on the Degree of Debilitation in Hospitalized Patients After Venous Hemolysis in Acute Ischemic Stroke

April 25, 2024 updated by: Affiliated Hospital of Nantong University

Effect of Multi-component Exercise Intervention Program on the Degree of Frailty in Hospitalized Patients After Venous Hemolysis in Acute Ischemic Stroke

Physical exercise is an effective strategy to maintain functional ability and improve debilitating symptoms in the elderly.In addition to functional enhancement, exercise is considered a cornerstone for enhancing cognitive function in debilitated older adults with cognitive impairment and dementia.The investigators evaluated the effect of the Vivifrail exercise intervention on the degree of debilitation in elderly hospitalized patients after venous hemolysis in acute ischemic stroke

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Elderly patients who are acutely hospitalized, including those who are able to walk independently, spend most of their stay in bed.In addition to worsening their functional status leading to significant muscle wasting and the development of other symptoms, it also increases the risk of cognitive decline and dementia in older adults, which is more pronounced in patients with acute ischemic stroke after venous hemolysis, and increases awareness of the need to replace prolonged bed rest with physical activity or exercise.Because there is evidence that this therapy during hospitalization is effective;A large number of studies have shown that rehabilitation training for AIS patients within 24 hours of onset is beneficial food.

In addition, exercise can reduce the damage caused by acute illness and hospitalization.Even so, it has not been established whether exercise therapy affects the degree of weakness or whether weakness affects response to treatment.

While frailty is not a disease, it can affect the presentation of many age-related diseases and the response to treatment.For example, after a short period of strength exercise in frail elderly people, autophagy in muscle cells is activated, affecting the overall health of the muscles and thus the ability to move.Similarly, the inflammatory response increases after vigorous aerobic exercise.It was also less clear whether individuals with higher frailty had any response to the intervention.

Multi-Component Exercise（Vivifrail） is an innovative multi-component exercise program that includes strength training, endurance training, balance training, and flexibility training to improve the exerciser's gait, balance, and cardiorespiratory function by increasing muscle mass, strength, and endurance.Recent studies have shown that it is one of the best ways to improve patients' gait, balance, cardiopulmonary function and cognitive executive function, as well as the best way to treat frailty, and can reduce the risk of falls and delay cognitive decline in elderly hospitalized patients with neurocognitive disorders.

The objective of this study was to examine the effect of exercise intervention on the level of frailty in older adults admitted for venous hemolysis for acute ischemic stroke.The effects of baseline frailty levels on the intervention, effectiveness of frailty, changes in Physical function (Modified Barthel Index (MBI), Short Physical Performance Battery (SPPB), and other health outcomes were determined.

Study Type

Interventional

Enrollment (Estimated)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: songshuang yan, postgraduate
  • Phone Number: 15806270059
  • Email: 1228973183@qq.com

Study Locations

  • China
    • Jiangsu
      • Nantong, Jiangsu, China, 226000
        • Recruiting
        • AHNantongU
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Over 65 years of age;
  2. Hospitalized patients diagnosed with ischemic stroke;
  3. barthel index ≥60;
  4. Muscle strength of both upper and lower limbs is above grade 3;
  5. The pre-frailty and frailty state of the modified 5 Frailty Index (mFI-5) standard;
  6. Patients willing to cooperate and sign informed consent

Exclusion Criteria:

  1. fracture (within three months),
  2. severe cognitive impairment, or severe dementia;
  3. unable or unwilling to cooperate, any other unstable medical condition, or conditions that would prevent physical activity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Routine exercise group
The routine exercise care group, that is, the control group, will complete the routine exercise care of patients with acute ischemic stroke after venous hemolytic surgery in accordance with the hospital regulations: From 24 hours after surgery, patients with mild and moderate stroke can be turned over in bed (once every 2 hours), ankle pump exercise (three times a day), and transitional bedside rehabilitation exercise (such as walking around the bed, etc.) after no discomfort.
Experimental: Multicomponent exercise group
Select the corresponding intervention according to the SPPB score:0-3 scores (Plan A) :1. Walking 2.Relax your hand 3.Lift a bottle 4.Leg extensions with an ankle weight 5.Getting up from a chair with help 6.Holding onto the person who helps you 7.Arm stretching 4-6 scores(Plan B):1. Walking 2.Lift a bottle 3.Squeeze a ball 4.pretend to sit 5.Walking on tip toes and heels 6.Arm stretching in a chair 7.Stretch your arms up with your hands clasped;7-9 scores(Plan C):1.Walking 2.Roll-up a small towel 3.Take two plastic bottles filled with 500ml of water 4.Getting up from a chair 5.Walking over obstacles 6.Walking in a figure of eight 7.Leg stretching sit in a chair 8.Arm stretching;10-12 scores( Plan D):1.Walking 2.Twist a towel 3.Lift a bottle 4.Getting up from a chair 5.Going up and down stairs 6.Walking in a figure of eight 7.Walking while touching a balloon 8.Arm stretching;See details at http://vivifrail.com/
Behavioral: Multi-component Exercise Intervention Program

The Vivifrail program (http://vivifrail.com) is a home-based exercise program that focuses on personalized multi-component exercise prescriptions based on an elderly person's functional abilities, including resistance/strength, balance, flexibility, and cardiovascular endurance exercise (i.e., walking).

During hospitalization, patients who meet the criteria of sodium intake will be screened, and then divided into groups according to the method of randomized controlled trial. The experimental group will carry out corresponding exercise plan according to the results of SPPB.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short Physical Performance Battery（SPPB）
Time Frame: This outcome measure will be assessed within the first 2 days（Day 2） and at 1 month（Month 1） after intravenous thrombolysis in acute ischemic stroke.

The SPPB test to determine the level of frailty is a composite of the following three separate measures:

  1. - Balance test.
  2. - Walking speed test over 4 meters.

  3. - Test of getting up from a chair. Add the points of the SPPB test (1 to 3) to determine the grade.

    • If due to limitations, you have not performed the SPPB test and you have elected to use the 6-meter walking test, the following values will be used to recommend the physical exercise program. Points 0-3 scores are considered as disability and given program A intervention; A score of 4-6 is considered as the early stage of asthenia and B intervention program is given; A score of 7-9 was considered as weak and C intervention program was given; A score of 10-12 is considered as healthy people and D intervention program is given
This outcome measure will be assessed within the first 2 days（Day 2） and at 1 month（Month 1） after intravenous thrombolysis in acute ischemic stroke.
Modified Barthel Index
Time Frame: This outcome measure will be assessed within the first 2 days（Day 2） and at 1 month（Month 1） after intravenous thrombolysis in acute ischemic stroke.
The assessment of the individual's daily living ability includes 10 items, including eating, decoration, bathing, etc. Each index is divided into 5 levels: complete dependence, greater dependence, medium dependence, lesser dependence, and independence. The higher the score, the better the independence of daily life, a total of 100 points
This outcome measure will be assessed within the first 2 days（Day 2） and at 1 month（Month 1） after intravenous thrombolysis in acute ischemic stroke.
FRAIL Scale
Time Frame: This outcome measure will be assessed within the first 2 days（Day 2） and at 1 month（Month 1） after intravenous thrombolysis in acute ischemic stroke.

Including fatigue, can not go up a flight of stairs, can not walk 500 m, suffering from more than 5 diseases, body mass decline a total of 5 indicators, using two classification scoring method, a total of 5 points.

0 was classified as no frailty, 1-2 as pre-frailty, and ≥3 as frailty.
This outcome measure will be assessed within the first 2 days（Day 2） and at 1 month（Month 1） after intravenous thrombolysis in acute ischemic stroke.
Grip
Time Frame: This outcome measure will be assessed within the first 2 days（Day 2） and at 1 month（Month 1） after intravenous thrombolysis in acute ischemic stroke.

Use electronic grip dynamometer (Model:

EH101) Before measurement, the instrument was calibrated to 0, the grip distance was adjusted, the fingers were naturally placed in the grip groove position, the study subjects were seated in the end position, the arm extension did not exceed 30 degrees, the upper arm and the forearm were 90 degrees, and the hands were measured with the maximum strength, the measurement interval was about 1 minute, so that the measuring hand could have enough relaxation and rest. A total of three tests were conducted.

Average the ultimate grip strength, accurate to 0.1kg.
This outcome measure will be assessed within the first 2 days（Day 2） and at 1 month（Month 1） after intravenous thrombolysis in acute ischemic stroke.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Health Questionaire - 9 items，PHQ -9
Time Frame: This outcome measure will be assessed within the first 2 days（Day 2） and at 1 month（Month 1） after intravenous thrombolysis in acute ischemic stroke.

It included 9 symptom scales and 1 overall functional assessment. Symptom scales were evaluated as follows: loss of interest, low mood, sleep disorders, fatigue, eating disorders, inferiority, difficulty in concentration, psychomotor delay, suicide symptoms, and item 10 was the overall functional assessment.

The item definition was expressed in the form of short sentences, with a 4-level score ranging from 0 to 3, and the frequency of symptom occurrence in nearly 2 weeks.

(0 indicates no symptoms, 1 indicates several days of symptoms, 2 indicates more than 7 days of symptoms, and 3 indicates almost every day of symptoms), the overall functional evaluation item is rated according to the degree of impact of symptoms on work, family or social function (0 indicates no, 1 indicates some impact, 2 indicates very impact, and 3 indicates very impact).
This outcome measure will be assessed within the first 2 days（Day 2） and at 1 month（Month 1） after intravenous thrombolysis in acute ischemic stroke.
HendrichⅡfall risk model,HFRM
Time Frame: Acute ischemic stroke was evaluated within 48h of intravenous thrombolysis up to 4 weeks.
There were 8 items including male, depressive state, dizziness, taking anti-epileptic drugs, standing up and walking test, and confusion. The total score was 16 points, and ≥5 was classified as high risk
Acute ischemic stroke was evaluated within 48h of intravenous thrombolysis up to 4 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Affiliated Hospital of Nantong University

Investigators

  • Study Chair: xuemei zhang, master, Affiliated hospital of Nantong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2024

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

January 7, 2024

First Submitted That Met QC Criteria

April 25, 2024

First Posted (Actual)

April 30, 2024

Study Record Updates

Last Update Posted (Actual)

April 30, 2024

Last Update Submitted That Met QC Criteria

April 25, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • zhangxuemei

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Exercise Intervention protocols

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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