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Interactive Hand-grip Strength Game in Critically Illness Patients

Primary Purpose

Critical Illness

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Hand-grip Strength Game
Sponsored by
Taipei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Critical Illness focused on measuring intensive care unit, Hand-grip Strength

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged ≥ 20 years
  • Having clear consciousness
  • Independently able to mobilize to complete the intervention and communicate in Chinese
  • Richmond Agitation-Sedation Scale (RASS) 24 between +1 to -1 if using sedatives

Exclusion Criteria:

  • Suspect neurological deficits
  • Neuromuscular disease
  • Orthopedic injuries with contraindications to mobilize

Sites / Locations

  • Taipei Medical University-Shuang Ho Hospital, Ministry of Health and WelfareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Hand-grip Strength Game

routine care

Arm Description

Participants will receive a hand-grip strength game for 5-20 minutes twice a day for consecutive three days.

The control group will not involve hand-grip strength game at night.

Outcomes

Primary Outcome Measures

Change from baseline on anxiety
Anxiety will be measured by Depression Anxiety Stress Scale-21 (DASS21). DASS21 of anxiety has 7 items of the questions are used to measure the severity of anxiety. The total score should be multiplied by 2 range from 0-42, if score>7 is associated with anxiety. The higher score means more severe anxiety.
Change from baseline on Post-traumatic stress disorder(PTSD)
The PTSD is assessed by Post-traumatic Stress Syndrome 10-question inventory (PTSS-10).The measurement involved 10 items and each item is rated using a seven-point Likert scale (1 "never" to 7 "always").
Change of Delirium incidence
The delirium event is assessed by Confusion Assessment Method for the ICU(CAM-ICU)
Change from baseline on depression
Depression will be measured by Depression Anxiety Stress Scale-21 (DASS21). DASS21 has 7 items of the questions are used to measure the severity of depression. The total score should be multiplied by 2 range from 0-42, if score>9 is associated with depression. The higher score means more severe depression.
Change from baseline on stress
Stress will be measured by Depression Anxiety Stress Scale-21 (DASS21). DASS21 has 7 items of the questions are used to measure the severity of stress. The total score should be multiplied by 2 range from 0-42, if score>14 is associated with anxiety. The higher score means more severe stress.

Secondary Outcome Measures

Changes of Pain
Pain is assessed by using the Critical-Care Pain Observation Tool (CPOT). The possible total score ranges from 0 (no pain) to 8 (maximum pain).
Change from baseline on sleep quality
Sleep quality in ICU is assessed by the Richards-Campbell Sleep Questionnaire(RCSQ). The mean of total score is 0-100. The higher score means the better sleep quality.
ICU acquired weakness
The ICU acquired weakness is assessed by Medical Research Council (MRC).The scale for grading the strength (i.e., 0, total palsy to 5, normal strength) in three functional muscle groups of each extremity (shoulder abduction, elbow flexion, and wrist extension for upper limb; hip flexion, knee extension, and ankle dorsiflexion for lower limb), with mean MRC-scores of <4 (antigravity strength).26,35 Summation of scores gives MRC-sums core, ranging from 0 to 60. The sum score also reliably identifies significant ICU-acquired weakness (< 48).

Full Information

First Posted
January 30, 2022
Last Updated
July 20, 2022
Sponsor
Taipei Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05298241
Brief Title
Interactive Hand-grip Strength Game in Critically Illness Patients
Official Title
Effects of Interactive Hand-grip Strength Game in Critically Illness Patients: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 3, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Patients admitted to the intensive care units (ICUs) are an unexpected event that consequently causes physical and psychological problems, including ICU acquired weakness, delirium, sleep disruptions, anxiety, depression, and post-traumatic stress disorder (PTSD). Such consequences may lead to prolonged ICU stay, increased health care, and elevated medical costs. Therefore, mitigating physical and psychological distresses by providing timely effective interventions has become a top concern to optimize critically ill patients' recovery. Investigators aim to design an interactive hand-grip game to improve patients' upper limbs activities and psychological health in patients requiring intensive care.
Detailed Description
Patients admitted to the intensive care units (ICUs) are an unexpected event that consequently causes physical and psychological problems, including ICU acquired weakness, delirium, sleep disruptions, anxiety, depression, and post-traumatic stress disorder (PTSD). Such consequences may lead to prolonged ICU stay, increased health care, and elevated medical costs. Therefore, mitigating physical and psychological distresses by providing timely effective interventions has become a top concern to optimize critically ill patients' recovery. Investigaters aim to design a interactive hand-grip game to improve patients' upper limbs activities and psychological health in patients requiring intensive care. This will be a two-arm, parallel randomized controlled trial which randomly assign patients into the game group and usual care group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
intensive care unit, Hand-grip Strength

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hand-grip Strength Game
Arm Type
Experimental
Arm Description
Participants will receive a hand-grip strength game for 5-20 minutes twice a day for consecutive three days.
Arm Title
routine care
Arm Type
No Intervention
Arm Description
The control group will not involve hand-grip strength game at night.
Intervention Type
Other
Intervention Name(s)
Hand-grip Strength Game
Intervention Description
Interactive Handgrip Strength Game for ICU patients receiving the game and to assess the impact on psychological.
Primary Outcome Measure Information:
Title
Change from baseline on anxiety
Description
Anxiety will be measured by Depression Anxiety Stress Scale-21 (DASS21). DASS21 of anxiety has 7 items of the questions are used to measure the severity of anxiety. The total score should be multiplied by 2 range from 0-42, if score>7 is associated with anxiety. The higher score means more severe anxiety.
Time Frame
The 1 day of enrollment, and 3th day of ICU.
Title
Change from baseline on Post-traumatic stress disorder(PTSD)
Description
The PTSD is assessed by Post-traumatic Stress Syndrome 10-question inventory (PTSS-10).The measurement involved 10 items and each item is rated using a seven-point Likert scale (1 "never" to 7 "always").
Time Frame
The 1st, and 3th day of ICU.
Title
Change of Delirium incidence
Description
The delirium event is assessed by Confusion Assessment Method for the ICU(CAM-ICU)
Time Frame
Every 8 hours during ICU stay up to 3 days
Title
Change from baseline on depression
Description
Depression will be measured by Depression Anxiety Stress Scale-21 (DASS21). DASS21 has 7 items of the questions are used to measure the severity of depression. The total score should be multiplied by 2 range from 0-42, if score>9 is associated with depression. The higher score means more severe depression.
Time Frame
The 1 day of enrollment, and 3th day of ICU.
Title
Change from baseline on stress
Description
Stress will be measured by Depression Anxiety Stress Scale-21 (DASS21). DASS21 has 7 items of the questions are used to measure the severity of stress. The total score should be multiplied by 2 range from 0-42, if score>14 is associated with anxiety. The higher score means more severe stress.
Time Frame
The 1 day of enrollment, and 3th day of ICU.
Secondary Outcome Measure Information:
Title
Changes of Pain
Description
Pain is assessed by using the Critical-Care Pain Observation Tool (CPOT). The possible total score ranges from 0 (no pain) to 8 (maximum pain).
Time Frame
Everyday during ICU stay up to 3 days
Title
Change from baseline on sleep quality
Description
Sleep quality in ICU is assessed by the Richards-Campbell Sleep Questionnaire(RCSQ). The mean of total score is 0-100. The higher score means the better sleep quality.
Time Frame
The 1st, and 3th day of ICU.
Title
ICU acquired weakness
Description
The ICU acquired weakness is assessed by Medical Research Council (MRC).The scale for grading the strength (i.e., 0, total palsy to 5, normal strength) in three functional muscle groups of each extremity (shoulder abduction, elbow flexion, and wrist extension for upper limb; hip flexion, knee extension, and ankle dorsiflexion for lower limb), with mean MRC-scores of <4 (antigravity strength).26,35 Summation of scores gives MRC-sums core, ranging from 0 to 60. The sum score also reliably identifies significant ICU-acquired weakness (< 48).
Time Frame
The 1st day of ICU.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged ≥ 20 years Having clear consciousness Independently able to mobilize to complete the intervention and communicate in Chinese Richmond Agitation-Sedation Scale (RASS) 24 between +1 to -1 if using sedatives Exclusion Criteria: Suspect neurological deficits Neuromuscular disease Orthopedic injuries with contraindications to mobilize
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hsiao-Yean Chiu, PhD
Phone
+886-2-27361661
Ext
6329
Email
hychiu0315@tmu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsiao-Yean Chiu, PhD
Organizational Affiliation
Taipei Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hisao Yean Chiu, PhD
Phone
886227361661
Ext
6329
Email
hychiu0315@tmu.edu.tw

12. IPD Sharing Statement

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Interactive Hand-grip Strength Game in Critically Illness Patients

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