Google Maps

NCT07741942

Overview

NCT ID: NCT07741942
Lead Sponsor: Seoul National University HospitalOTHER
Official Title: Feasibility Study of a Remote Exercise Intervention Program for Preventing Post-Intensive Care Syndrome in Pediatric Critical Illness Survivors
Brief Summary: This pilot clinical trial aims to evaluate the feasibility and safety of a remote exercise intervention program designed to prevent pediatric post-intensive care syndrome (PICS-p) in children discharged from the pediatric intensive care unit (PICU). Children aged 3 to 18 years who received intensive care for at least 48 hours and have not recovered to their pre-admission functional status will participate in an individualized home-based exercise program for 12 weeks. The intervention includes remotely supervised exercise sessions, prescribed self-exercise, and weekly monitoring using videoconferencing. Study assessments will be performed at baseline, immediately before intervention initiation, monthly during the 12-week intervention, and 1 month after completion of the intervention to evaluate feasibility, safety, functional recovery, and maintenance of treatment effects.
Conditions

Ages Eligible for Study: Child (0-17)Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Age 3 to 18 years.

Discharged from the pediatric intensive care unit (PICU) after at least 48 hours of treatment.

Has not recovered to the pre-PICU level of physical function (walking and mobility), confirmed using the Pediatric Overall Performance Category Scale (POPC) and the Gross Motor Function Classification System Family Report Questionnaire (GMFCS Family Report).

Has sufficient cognitive and physical ability to understand and participate in the home-based exercise intervention.

Able to maintain adequate attention for exercise training, assessed using the Richmond Agitation-Sedation Scale (RASS) and age-appropriate delirium assessment (psCAM-ICU or pCAM-ICU), when applicable.

Written informed consent provided by the parent or legal guardian.

Exclusion Criteria:

Newly developed neuromuscular disease after PICU admission that prevents participation in the video-based exercise program without therapist assistance.

Medical conditions, indwelling catheters, or implanted medical devices requiring restriction of limb movement.

Language or cognitive impairment that prevents understanding of the video-based exercise program.

Uncontrolled hypertension, arrhythmia, persistent fever due to infection, or any condition making exercise unsafe.

Declines to participate in the study.

Central Contacts: Seung Ha Lee, M.S.Contact
pedshlee@gmail.com+82-2-2072-3608