Critical IllnessNCT05298241
Interactive Hand-grip Strength Game in Critically Illness Patients
A study testing Hand-grip Strength Game in people with Critical Illness, run by Taipei Medical University at 1 site in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Hand-grip Strength Game
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Oct 2021to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Suspect neurological deficits
- Neuromuscular disease
- Orthopedic injuries with contraindications to mobilize
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare
Taipei, 110
About this study
Official title: 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.
Read the 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.
- Conditions
- Critical Illness
- Being tested
- Hand-grip Strength Game
- Keywords
- intensive care unit, Hand-grip Strength
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand-grip Strength GameOther
Interactive Handgrip Strength Game for ICU patients receiving the game and to assess the impact on psychological.
| Study group | Role | What they receive |
|---|---|---|
| Hand-grip Strength Game | Experimental | Participants will receive a hand-grip strength game for 5-20 minutes twice a day for consecutive three days. Receives: Other: Hand-grip Strength Game |
| routine care | No intervention | The control group will not involve hand-grip strength game at night. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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").
Measured: 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)
Measured: 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.
Measured: 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.
Measured: The 1 day of enrollment, and 3th day of ICU.
Secondary outcomes (3)
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).
Measured: 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.
Measured: 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).
Measured: The 1st day of ICU.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start21 Oct 2021
- Primary completion21 Nov 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsiao-Yean Chiu, Taipei Medical University
- Investigators
- Hsiao-Yean Chiu, PhD, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05298241
- Sponsor's protocol ID
- N202102007
- Status last verified
- Apr 2024
- First submitted
- 30 Jan 2022
- Last updated
- 22 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Interactive Hand-grip Strength Game in Critically Illness Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05298241
- Acronym / sponsor ID
- N202102007
- Conditions
- Critical Illness
- Keywords
- intensive care unit, Hand-grip Strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- 21 Nov 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 28 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hand-grip Strength Game | Experimental | Other: Hand-grip Strength GameParticipants will receive a hand-grip strength game for 5-20 minutes twice a day for consecutive three days. |
| routine care | No intervention | –The control group will not involve hand-grip strength game at night. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Suspect neurological deficits
- Neuromuscular disease
- Orthopedic injuries with contraindications to mobilize
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hand-grip Strength GameInteractive Handgrip Strength Game for ICU patients receiving the game and to assess the impact on psychological. | Other | Hand-grip Strength Game |
Primary outcome
Change from baseline on anxiety
Time frame: The 1 day of enrollment, and 3th day of ICU.
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)
Time frame: The 1st, and 3th day of ICU.
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
Time frame: Every 8 hours during ICU stay up to 3 days
The delirium event is assessed by Confusion Assessment Method for the ICU(CAM-ICU)
Change from baseline on depression
Time frame: The 1 day of enrollment, and 3th day of ICU.
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
Time frame: The 1 day of enrollment, and 3th day of ICU.
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.
3 secondary outcomes
Changes of Pain
Time frame: Everyday during ICU stay up to 3 days
Change from baseline on sleep quality
Time frame: The 1st, and 3th day of ICU.
ICU acquired weakness
Time frame: The 1st day of ICU.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsiao-Yean Chiu, PhD principal investigator
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand-grip Strength Game in people with Critical Illness, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline on anxiety (time frame: The 1 day of enrollment, and 3th day of ICU.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024.