Post Intensive Care Optimization Through Lifestyle Intervention

NCT ID: NCT06771895

Last Updated: 2025-05-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2028-04-30

Brief Summary

The quality of the intensive care unit (ICU) has been steadily improving over the years. Although improvements in the acute treatment of critically ill patients have been made, a large number of ICU survivors suffer from severe physical, cognitive and mental health problems persisting months to years after leaving the ICU. Physical impairments occur the most and can be very severe, greatly affecting activities in daily life and subsequently the perceived quality of life of ICU survivors. Although there is an increased awareness of long-term complaints following ICU stay, there is currently a knowledge gap on how to enhance the recovery of ICU survivors 6 to 12 months post-ICU discharge. The overall objective of the current study is to establish the extent of health and functional improvements that can be obtained with an optimized, combined exercise and nutritional intervention in ICU survivors 6 to 12 months post-ICU discharge.

Conditions

ICU Survivor; Muscle Weakness

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

Group Type: EXPERIMENTAL

Combined exercise and nutritional intervention

Intervention Type: BEHAVIORAL

The intervention consists of a combined exercise and nutritional intervention. All subjects will perform 20 weeks of supervised resistance and endurance type exercise training 2 to 3 days per week. The dietary intervention aims to attain a diet that comprises sufficient protein and is otherwise in line with the Dutch Healthy Diet guidelines. In support, subjects will consume a daily high protein multi-nutrient supplement which will be ingested pre-sleep. There will be an additional supplement intake moment following each training session.

Interventions

Combined exercise and nutritional intervention

The intervention consists of a combined exercise and nutritional intervention. All subjects will perform 20 weeks of supervised resistance and endurance type exercise training 2 to 3 days per week. The dietary intervention aims to attain a diet that comprises sufficient protein and is otherwise in line with the Dutch Healthy Diet guidelines. In support, subjects will consume a daily high protein multi-nutrient supplement which will be ingested pre-sleep. There will be an additional supplement intake moment following each training session.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Aged 18 years and older
• Minimum ICU length of stay of 5 days and/or mechanically ventilated for a minimum of 2 days
• Persistent physical complaints
• Community-dwelling, living independently (non-assisted)
• Mentally competent with a Mini-Mental State Examination (MMSE) score of ≥24
• Willing to participate in a 20-week multimodal lifestyle intervention

Exclusion Criteria

• Any medical condition that may interfere with the safety of the subjects during exercise or any condition that interferes with assessment of the outcome parameters, in the investigators' judgement in consultation with the responsible physician or treating physician/specialist. In case of a contra-indication for MRI (e.g., a pacemaker), subjects will be excluded from this measurement but not necessarily from the study.
• Any medical condition or circumstance where supplementation with the nutritional supplement is potentially contra-indicated.
• Known allergy to any of the ingredients present in the nutritional supplement.
• Simultaneous use of other nutritional supplements during the study period (i.e., unwillingness to stop for the duration of the study).
• Current participation in other scientific research that conflicts with this study (e.g. intervention studies or weight management studies).
• No permission to request information from the general practitioner/treating specialist(s) about medical history, medication use.

• Pregnancy.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Danone Global Research & Innovation Center

INDUSTRY

Sponsor Role: collaborator

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lex B Verdijk, Dr.

Role: PRINCIPAL_INVESTIGATOR

Maastricht University

Luc JC van Loon, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Maastricht University

Locations

Maastricht University Medical Center+

Maastricht, Limburg, Netherlands

Countries

Netherlands

Central Contacts

Bram AJM Sauvé

Role: CONTACT

bram.sauve@maastrichtuniversity.nl

+31433885836

Lex B Verdijk, Dr.

Role: CONTACT

lex.verdijk@maastrichtuniversity.nl

+31433881318

Facility Contacts

Lex B Verdijk, Dr.

Role: primary

lex.verdijk@maastrichtuniversity.nl

+31433881318

Other Identifiers

METC 24-059

Identifier Type: -

Identifier Source: org_study_id