Rehabilitation After Intensive Care

NCT ID: NCT01770821

Last Updated: 2024-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Rehabilitation of Muscle Strength

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Standard physical training & standard nutrition

Standard of care

Group Type ACTIVE_COMPARATOR

Dietary supplement and/or physical training

Intervention Type OTHER

Tailored physical training and sipdrink

Tailored physical training and sipdrink (Protein nutridrink, 200 ml x 2)

Group Type EXPERIMENTAL

Dietary supplement and/or physical training

Intervention Type OTHER

Tailored physical training and standard nutrition.

Standard physical training provided by the hospital and standard hospital nutrition

Group Type EXPERIMENTAL

Dietary supplement and/or physical training

Intervention Type OTHER

Standard physical training and sip drink

Standard physical training provided by the hospital and sipdrink (Nutridrink protein, 200 ml x2)

Group Type EXPERIMENTAL

Dietary supplement and/or physical training

Intervention Type OTHER

Interventions

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Dietary supplement and/or physical training

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Haukeland University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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Innovest

Identifier Type: OTHER

Identifier Source: secondary_id

2009-2134

Identifier Type: -

Identifier Source: org_study_id

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