Combined Activity and Cognitive Intervention for ICU Survivors

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. 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.

Conditions

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

Interventions

OTHER

Attention Placebo

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.

OTHER

Home-based exercises combined with cognitive training

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.

OTHER

Home-based exercises

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.

Sponsors & Collaborators

• The University of Hong Kong

  lead OTHER

Principal Investigators

• Polly Li, Dr · The University of Hong Kong, School of Nursing

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-12-01

Primary Completion

2025-11-12

Completion

2026-02-12

Countries

• Hong Kong

Study Locations