Combined Activity and Cognitive Intervention for ICU Survivors

NCT06117761 | Enrolling By Invitation

• 1 other identifier: UW23-271
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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). 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. 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. 2.To explore the feasibility and acceptability of the COMBAT-ICU intervention and ICU survivors' intervention engagement experience.

Conditions

Post Intensive Care Syndrome; ARDS: Acute Respiratory Distress Syndrome; Delirium; Loss of Muscle Mass; Loss of Muscle Strength; Cognitive Function

Keywords

Post-intensive care syndrome; PICS; Intensive Care Unit; ICU survivors; home-based exercise

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (12)

• 6-Minute Walk Test (6MWT)

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

• Time-Up-Go test

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

• Short Physical Performance Battery

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

• Grip strength

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

• Digit Span test

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

Study Arms (3)

COMBAT-ICU

EXPERIMENTAL

The 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.

Other: Home-based exercises combined with cognitive training

Exercise Group

EXPERIMENTAL

The 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.

Other: Home-based exercises

Attention Placebo Group

PLACEBO COMPARATOR

The 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.

Other: Attention Placebo

Interventions

Attention Placebo OTHER

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.

Attention Placebo Group

Home-based exercises combined with cognitive training OTHER

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.

COMBAT-ICU

Home-based exercises OTHER

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.

Exercise Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The School of Nursing

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

postintensive care syndrome; Acute Lung Injury; Delirium

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Polly Li, Dr

  The University of Hong Kong, School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 15, 2023
• First Posted: November 7, 2023
• Study Start: December 1, 2023
• Primary Completion: November 12, 2025
• Study Completion: February 12, 2026
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)