Interactive Hand-grip Strength Game in Critically Illness Patients

Effects of Interactive Hand-grip Strength Game in Critically Illness Patients: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness
• Intervention / Treatment: Other: Hand-grip Strength Game

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 110
    • Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hand-grip Strength Game; Participants will receive a hand-grip strength game for 5-20 minutes twice a day for consecutive three days.	Other: Hand-grip Strength Game; Interactive Handgrip Strength Game for ICU patients receiving the game and to assess the impact on psychological.
No Intervention: routine care; The control group will not involve hand-grip strength game at night.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The 1 day of enrollment, and 3th day of ICU.
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").	The 1st, and 3th day of ICU.
Change of Delirium incidence	The delirium event is assessed by Confusion Assessment Method for the ICU(CAM-ICU)	Every 8 hours during ICU stay up to 3 days
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.	The 1 day of enrollment, and 3th day of ICU.
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.	The 1 day of enrollment, and 3th day of ICU.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Everyday during ICU stay up to 3 days
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.	The 1st, and 3th day of ICU.
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).	The 1st day of ICU.

Collaborators and Investigators

• Sponsor: Taipei Medical University
• Investigators: Principal Investigator: Hsiao-Yean Chiu, PhD, Taipei Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2021
• Primary Completion (Actual): November 21, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: January 30, 2022
• First Submitted That Met QC Criteria: March 25, 2022
• First Posted (Actual): March 28, 2022

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: intensive care unit; Hand-grip Strength
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: N202102007

Drug and device information, study documents

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