Rehabilitation After Intensive Care (REHAB)

This study is not yet open for participant recruitment.
Verified January 2013 by Haukeland University Hospital
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT01770821
First received: January 16, 2013
Last updated: March 22, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Rehabilitation of Muscle Strength
Other: Dietary supplement and/or physical training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: REHABILITATION AFTER INTENSIVE CARE What Effect Does Physiotherapy and Proteinrich Sip Drink Have on Physical Performance, Bodycomposition, Bodyweight and Quality of Life?

Resource links provided by NLM:


Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • 6 minutes walking test (6MWT) (when the patient leave hospital, 12 weeks and 12 months) [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Isometric quadriceps strength, Isometrisk handgrip strength, Bodyweight Bodycomposition (Dexa) [ Time Frame: One year ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: February 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01770821     History of Changes
Other Study ID Numbers: 2009-2134, Innovest
Study First Received: January 16, 2013
Last Updated: March 22, 2013
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Haukeland University Hospital:
sip drink
protein
muscle strength
6 minutes walking test

ClinicalTrials.gov processed this record on April 21, 2014