Post Intensive Care Optimization Through Lifestyle Intervention (PICOLI)

Maastricht University Medical Centre (MUMC)

Status

Not yet enrolling

Conditions

ICU Survivor

Muscle Weakness

Treatments

Behavioral: Combined exercise and nutritional intervention

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06771895

METC 24-059

Details and patient eligibility

About

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.

Enrollment

35 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.