Rehabilitation After Intensive Care

Study Overview
=================
Brief Summary
-----------------
Patients with critical illness loose bodymass, mainly muscle. The purpose of the present study is to evaluate wheather tailored physical training and/or a sip drink (proteinrich) have effect on the six minutes walking test (6MWT), muscle strength, body weight, body composition and quality of life after intensive care. This is a single center randomised controled study comprising patients ≥45 years of age staying 5 days or more in the intensive care unit (ICU). The design is factorial. Inclusion takes place when the patient is leaving the ICU.

Official Title
-----------------
REHABILITATION AFTER INTENSIVE CARE What Effect Does Physiotherapy and Proteinrich Sip Drink Have on Physical Performance, Bodycomposition, Bodyweight and Quality of Life?

Conditions
-----------------
Rehabilitation of Muscle Strength

Intervention / Treatment
-----------------
* Other: Dietary supplement and/or physical training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ICU patients ≥45 years with LOS ≥ 5days Exclusion Criteria: Patients < 45 years, Cerebral function that make cooperation impossible, Fractures in the spine, pelvis and/or lower extremities, Unable to perform the intervention LOS < 5 days

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard physical training & standard nutrition<br>Standard of care | Other: Dietary supplement and/or physical training<br> <br> |
| Experimental: Tailored physical training and sipdrink<br>Tailored physical training and sipdrink (Protein nutridrink, 200 ml x 2) | Other: Dietary supplement and/or physical training<br> <br> |
| Experimental: Tailored physical training and standard nutrition.<br>Standard physical training provided by the hospital and standard hospital nutrition | Other: Dietary supplement and/or physical training<br> <br> |
| Experimental: Standard physical training and sip drink<br>Standard physical training provided by the hospital and sipdrink (Nutridrink protein, 200 ml x2) | Other: Dietary supplement and/or physical training<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 minutes walking test (6MWT) (when the patient leave hospital, 12 weeks and 12 months) |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Isometric quadriceps strength, Isometrisk handgrip strength, Bodyweight Bodycomposition (Dexa) |  | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sip drink, protein, muscle strength, 6 minutes walking test