Rehabilitation After Intensive Care (REHAB)

February 29, 2024 updated by: Haukeland University Hospital

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Quality of life SF-36 (when leaving hospital, after 12 weeks and 12 months Body weight (leaving the ICU, after 12 weeks, after 12 months) Body composition (leaving the ICU, after 12 weeks, after 12 months)
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haukeland University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2013

Primary Completion (Estimated)

February 1, 2016

Study Completion (Estimated)

December 1, 2016

Study Registration Dates

First Submitted

January 16, 2013

First Submitted That Met QC Criteria

January 16, 2013

First Posted (Estimated)

January 18, 2013

Study Record Updates

Last Update Posted (Estimated)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2009-2134
  • Innovest (Other Identifier: Haukeland University Hospital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rehabilitation of Muscle Strength

Clinical Trials on Dietary supplement and/or physical training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe