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Post Intensive Care Optimization through Lifestyle Intervention

Post Intensive Care Optimization through Lifestyle Intervention - PICOLI

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON57563
Enrollment
35
Registered
2024-11-29
Start date
2025-10-21
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

intensive care survivors, persistent physical complaints after ICU

Interventions

The intervention consists of a combined exercise and nutritional intervention.&nbsp
All subjects will perform 20 weeks of supervised resistance and endurance type&nbsp
exercise training 2 to 3 days per week. Leg press, leg extension, calf raises,&nbsp
chest press, shoulder press, horizontal row and vertical lateral pull exercise&nbsp
will be performed on weightlifting machines in addition to cycling on an&nbsp
ergometer. The dietary intervention aims to attain a diet that comprises&nbsp
sufficient protein, with a minimum of 1.2 g/kg bodyweight/day distributed as&nbsp
25-30 g protein per main meal, and is otherwise in line with the Dutch Healthy&nbsp
Diet guidelines. In support, subjects will consume a daily multi-nutrient&nbsp
supplement containing leucine-enriched whey protein, vitamin D, omega-3 long&nbsp
chain polyunsaturated fatty acids (n-3 lcPUFA), calcium, choline and pre- and&nbsp
probiotics, which will be ingested pre-sleep. There will be an additional&nbsp
supplement intake moment following each training session.

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion 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

Exclusion criteria: • Any medical condition that may interfere with the safety of the subjects  during the intervention (exercise/supplement) 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. • Known allergy to any of the ingredients present in the nutritional  supplement, requiring a fiber-free diet or suffering from galactosemia or  lactose intolerance. • Simultaneous use of other nutritional supplements and use of other pro-  and/or prebiotics 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.• Not pregnant

Design outcomes

Primary

MeasureTime frame
The main study endpoints are muscle strength (one-repetition maximum strength test), muscle mass (whole-body MRI) and aerobic capacity (cycling VO2peak test).

Secondary

MeasureTime frame
The secondary study endpoints are overall perceived QoL, physical function, (gut, brain and metabolic) health, and skeletal muscle characteristics.

Countries

Netherlands

Contacts

Public ContactB.A.J.M. Sauvé

Universiteit Maastricht

bram.sauve@maastrichtuniversity.nl+31433885836

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)