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Post Intensive Care SyndromeNCT06117761

Combined Activity and Cognitive Intervention for ICU Survivors

A study testing Home-based exercises combined with cognitive training and Home-based exercises in people with Post Intensive Care Syndrome and ARDS: Acute Respiratory Distress Syndrome, run by The University of Hong Kong at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This mixed-methods study comprising a 3-arm pilot RCT and a qualitative study aims to investigate the preliminary effects and feasibility of a home-based combined activity and cognitive intervention for ICU survivors (COMBAT-ICU). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Home-based exercises combined with cognitive training and Home-based exercises
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteHong Kong
Study dates
1 Dec 2023to 12 Feb 2026
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Chinese adults aged ≥18
  • has been admitted to ICU for at least 4 days
  • discharged home
  • able to perform basic activities of daily living before ICU admission
  • living with family
  • has an electronic device that can access the internet (patient/family)
  • able to walk for at least 10 metres (assisted or unassisted)

Who cannot join

  • cannot read Chinese
  • has musculoskeletal injury precluding exercise training
  • is receiving structured out-patient pulmonary or cardiac rehabilitation after discharge
  • has clinically evident dementia or significant impairment from an acute brain problem (e.g. traumatic brain injury, stroke, subarachnoid haemorrhage or hypoxic brain injury) that precludes following the study protocol
  • has prolonged length of stay (≥28 days) in the step-down wards

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site
  • The School of Nursing

    Hong Kong

Other trials in Hong Kong

About this study

Official title: Combined Activity and Cognitive Intervention to Optimize Recovery From Critical Illness in ICU Survivors: COMBAT-ICU Trial

This mixed-methods study comprising a 3-arm pilot RCT and a qualitative study aims to investigate the preliminary effects and feasibility of a home-based combined activity and cognitive intervention for ICU survivors (COMBAT-ICU). Adopting a 3-arm design with COMBAT-ICU, exercise and attention placebo study arms will enable us to evaluate the added effects, if any, of the novel combined intervention compared with the standard exercise-only rehabilitation strategy and attention placebo. Data triangulation from quantitative and qualitative aspects can facilitate result interpretation. The study's objectives are:

  1. To evaluate the preliminary effects of the COMBAT-ICU intervention for ICU survivors on PICS, physical, mental and cognitive outcomes, HRQoL, unplanned re-hospitalisation rate, and mortality.
  2. To explore the feasibility and acceptability of the COMBAT-ICU intervention and ICU survivors' intervention engagement experience.

The hypothesis of the first objective is that upon completion of the COMBAT-ICU intervention, ICU survivors will have reduced PICS, improved physical function, mental health, cognition and HRQoL, and reduced unplanned readmissions and mortality compared with the exercise and attention placebo groups at post-intervention and 3 months thereafter. While the hypothesis of the second objective is that the COMBAT-ICU intervention is feasible and acceptable for ICU survivors.

Read the detailed description

With the growing cohort of patients surviving after ICU treatment, the long-term consequences of critical illness have gained increased attention in the past decade. It is common for ICU survivors to experience long-term impairments in one or more domains of physical, cognitive or psychological functioning that persist beyond acute care hospitalization for a critical illness, impairments that are collectively known as post-intensive care syndrome (PICS).

As PICS is a relatively new syndrome, research is accumulating on different approaches to tackling it. There are several limitations on previous studies, such as only a single strategy, an exercise intervention, was tested to manage physical impairment or PICS as a whole, or no beneficial effect was documented on health-related QoL, leaving a significant gap in the literature. Hence, a multimodal rehabilitative approach is needed for this vulnerable cohort in promoting physical, functional and cognitive performance so as to develop effective strategies to prevent and manage PICS among ICU survivors, particularly during the early post-discharge period.

This study is mixed-methods comprising a 3-arm pilot RCT and a qualitative study aims to investigate the preliminary effects and feasibility of a home-based combined activity and cognitive intervention for ICU survivors (COMBAT-ICU), with assessments measured at baseline, immediate post-intervention and 3 months post-intervention. It will be conducted in three public hospitals in Hong Kong. Patients fulfilling the following eligibility criteria will be recruited: 1) Chinese adults aged ≥18; 2) has been admitted to ICU for at least 4 days; 3) has been discharged home; 4) was able to perform basic activities of daily living before ICU admission; 5) is living with family; 6) has an electronic device that can access the internet (patient/family); 7) is able to walk for at least 10 metres (assisted or unassisted).

Participants will be randomly allocated in a 1:1:1 ratio to the COMBAT-ICU, exercise or attention placebo groups.

For the COMBAT-ICU group, they will receive an intervention which will last for 8 weeks, with 3 sessions per week. A blended training platform with supervised in-person home visits and a real-time supervised online and unsupervised self practice approach will be used to deliver the intervention, with the platform gradually shifted from home visits to unsupervised self-practice according to participants' physical functioning level. Family caregivers will be involved in the intervention, so that they can facilitate home-based training. Each intervention session will last for 80 minutes and comprise 45 minutes of exercise training, a 5-minute break and 30 minutes of cognitive training. Moreover, all participants in the COMBAT-ICU group will be invited to complete a satisfaction survey and semi-structured qualitative interview, which will focus on exploring the acceptability and perceived effects from participants' perspective.

For the exercise group, they will receive an 8-week, home-based, exercise intervention which is the same as that of the exercise component of the COMBAT-ICU intervention, 3 sessions per week, and 45 minutes per session, but will not receive any structured cognitive training.

For the attention placebo group, they will receive a telephone call every 2 weeks, with the conversation focused on information provision and brief counselling relating to their health conditions, in order to reduce the potential bias from greater attention for the COMBAT-ICU and exercise groups. They will also receive the routine care provided by the healthcare system, including medical follow-ups with the clinical team, without structured out-patient rehabilitation services.

Evaluative outcomes will be measured at baseline (T0), immediate post-intervention (T1) and 3 months post-intervention (T2), and include Post-Intensive Care Syndrome Questionnaire (PICSQ), muscle mass and strength, physical performance, cognition function, psychological distress, Health-related quality of life (HRQoL), hospital readmission and mortality.

Being tested
Attention Placebo, Home-based exercises combined with cognitive training, Home-based exercises
Keywords
Post-intensive care syndrome, PICS, Intensive Care Unit, ICU survivors, home-based exercise
Medical subject headings
postintensive care syndrome, Acute Lung Injury, Delirium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Attention PlaceboOther

    Telephone follow-up focused on information provision and brief counselling relating to their health conditions. They will also receive routine care from the healthcae system, including medical follow-ups with the clinical team, without structured out-patient rehabilitation services.

  • Home-based exercises combined with cognitive trainingOther

    An 8-week, home-based, exercise with cognitive training intervention. 3 sessions per week, and 80 minutes per session.It comprises of 45 minutes of exercise training, a 5-minute break and 30 minutes of cognitive training.A blended training platform with supervised in-person home visits and a real-time supervised online and unsupervised selfpractice approach will be used to deliver the intervention, with the platform gradually shifted from home visits to unsupervised self-practice according to participants' physical functioning level. Family caregivers will be involved in the intervention, so that they can facilitate home-based training. Each intervention session will last for 80 minutes and comprise 45 minutes of exercise training, a 5-minute break and 30 minutes of cognitive training.

  • Home-based exercisesOther

    An 8-week, home-based, exercise-only intervention. Weeks 1 and 2 will be the induction phase, all sessions will be supervised with two home visit sessions and one online session in real-time. Weeks 3 to 6 will be the maintenance phase. For participants with a higher functional performance level (Level 3 or 4), the mode of delivery will change to one home visit and two online training sessions. Weeks 7 and 8 will be the consolidation phase, consisting of two online sessions and one unsupervised self-practice session. They will not receive any structured cognitive training.

Study groups in NCT06117761
Study groupRoleWhat they receive
COMBAT-ICUExperimentalThe COMBAT-ICU group will receive an intervention which will last for 8 weeks, with 3 sessions per week. A blended training platform with supervised in-person home visits and a real-time supervised online and unsupervised selfpractice approach will be used to deliver the intervention, with the platform gradually shifted from home visits to unsupervised self-practice according to participants' physical functioning level. Family caregivers will be involved in the intervention, so that they can facilitate home-based training. Each intervention session will last for 80 minutes and comprise 45 minutes of exercise training, a 5-minute break and 30 minutes of cognitive training. Moreover, all participants in the COMBAT-ICU group will be invited to complete a satisfaction survey and semi-structured qualitative interview, which will focus on exploring the acceptability and perceived effects from participants' perspective.
Receives: Other: Home-based exercises combined with cognitive training
Exercise GroupExperimentalThe exercise group will receive an 8-week, home-based, exercise intervention which is the same as that of the exercise component of the COMBAT-ICU intervention, 3 sessions per week, and 45 minutes per session, but will not receive any structured cognitive training.
Receives: Other: Home-based exercises
Attention Placebo GroupPlacebo comparatorThe attention placebo group will receive a telephone call every 2 weeks, with the conversation focused on information provision and brief counselling relating to their health conditions, in order to reduce the potential bias from greater attention for the COMBAT-ICU and exercise groups. They will also receive the routine care provided by the healthcare system, including medical follow-ups with the clinical team, without structured out-patient rehabilitation services.
Receives: Other: Attention Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient-reported PICS

    The 18-item Post-Intensive Care Syndrome Questionnaire (PICSQ) will be used to measure the extent of PICS. The PICSQ consists of 3 subscales, physical, cognitive and mental, and is rated on a 4-point Likert scale ranging from 0 to 3. It has good internal consistency (Cronbach's alpha = 0.93). Its criterion validity is evidenced by its strong correlation with frailty and HRQoL measures, and factor analysis confirmed its construct validity.

    Measured: At baseline (T0), immediate post-intervention: 8 weeks (T1) and 3 months post-intervention (T2)

Secondary outcomes (12)
  1. 6-Minute Walk Test (6MWT)

    6MWT will be used to evaluate aerobic capacity and endurance. Standard measurement guidelines will be followed, and the distance walked will be recorded.

    Measured: At baseline (T0), immediate post-intervention: 8 weeks (T1) and 3 months post-intervention (T2)

  2. Time-Up-Go test

    Time-Up-Go test will be used to measure functional mobility, assessed by the time it takes to stand up, walk a distance of 10 feet, turn, walk back and sit down.

    Measured: At baseline (T0), immediate post-intervention: 8 weeks (T1) and 3 months post-intervention (T2)

  3. Short Physical Performance Battery

    The Short Physical Performance Battery will be used to assess functional capacity. It consists of 3 timed tasks: standing balance, walking speed and chair stand tests.

    Measured: At baseline (T0), immediate post-intervention: 8 weeks (T1) and 3 months post-intervention (T2)

  4. Grip strength

    Handgrip strength will be assessed by a dynamometer to evaluate muscle strength of upper limbs.

    Measured: At baseline (T0), immediate post-intervention: 8 weeks (T1) and 3 months post-intervention (T2)

  5. Digit Span test

    The Digit Span test will be used to measure short-term and working memory.

    Measured: At baseline (T0), immediate post-intervention: 8 weeks (T1) and 3 months post-intervention (T2)

  6. Colour Trails Test

    Colour Trails Test to measure executive function and attention. It has two parts: part 1 assesses visual-motor processing speed and attention, and part 2 sequencing and mental flexibility in addition to processing speed and attention.

    Measured: At baseline (T0), immediate post-intervention: 8 weeks (T1) and 3 months post-intervention (T2)

  7. Montreal Cognitive Assessment

    The Montreal Cognitive Assessment will be used to assess global cognition

    Measured: At baseline (T0), immediate post-intervention: 8 weeks (T1) and 3 months post-intervention (T2)

  8. Patient Health Questionnaire-9

    The Patient Health Questionnaire-9 will be used to measure the frequency of depressive symptoms in the past 14 days. Its 9 items are rated on a 4-point scale ranging from 0 to 3, with higher sum scores indicating more depressive symptoms.

    Measured: At baseline (T0), immediate post-intervention: 8 weeks (T1) and 3 months post-intervention (T2)

  9. Generalized Anxiety Disorder Scale-7

    The Generalized Anxiety Disorder Scale-7 will be used to measure anxiety levels. Ratings on a 4-point scale (0-3) indicate the frequency of anxiety symptoms in the past 14 days, with higher total scores representing greater anxiety.

    HRQoL: The EuroQol Five Dimensions Five Levels (EQ-5D-5L) will be used to measure HRQoL. It consists of two parts: EQ-5D descriptive system and EQ visual analogue scale. The first part uses 5 levels to indicate a participant's health state on 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression - and the second part is an additional self-rated health item rated on a visual analogue scale ranging from 0-100.

    Measured: At baseline (T0), immediate post-intervention: 8 weeks (T1) and 3 months post-intervention (T2)

  10. EuroQol Five Dimensions Five Levels (EQ-5D-5L)

    EQ-5D-5L will be used to measure health-related quality of life. It consists of two parts: EQ-5D descriptive system and EQ visual analogue scale. The first part uses 5 levels to indicate a participant's health state on 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression - and the second part is an additional self-rated health item rated on a visual analogue scale ranging from 0-100.

    Measured: At baseline (T0), immediate post-intervention: 8 weeks (T1) and 3 months post-intervention (T2)

  11. Unplanned hospital readmission

    Hospital utilisation data will be monitored from T0 to T2 through electronic medical record review.

    Measured: From baseline (T0) to 3 months post-intervention (T2)

  12. mortality

    mortality will be monitored from T0 to T2 through electronic medical record review.

    Measured: From baseline (T0) to 3 months post-intervention (T2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2023
  2. Study start1 Dec 2023
  3. Primary completion12 Nov 2025 (estimated)
  4. Study completion12 Feb 2026 (estimated)

Resources

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
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06117761
Sponsor's protocol ID
UW23-271
Status last verified
May 2024
First submitted
15 Oct 2023
Last updated
9 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Li PWC, Tong CK, Lai PCK, Ng PY, Chan SCS, Ho MH, Yu DSF. Home-Based Combined Activity and Cognitive Intervention for Post-Intensive Care Syndrome: A Pilot Randomised Controlled Trial. Nurs Crit Care. 2026 Jul;31(4):e70548. doi: 10.1111/nicc.70548.

    PubMed 42345586

Questions about this trial

What is this clinical trial studying?

A study testing Home-based exercises combined with cognitive training and Home-based exercises in people with Post Intensive Care Syndrome and ARDS: Acute Respiratory Distress Syndrome, run by The University of Hong Kong at 1 site in Hong Kong.

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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 9 May 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 Hong Kong. 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. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

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?

Patient-reported PICS (time frame: At baseline (T0), immediate post-intervention: 8 weeks (T1) and 3 months post-intervention (T2)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06117761, which also lists 1 linked publication.

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 9 May 2024.

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