Standard vs Intensive Rehabilitation and Nutrition Regimen for Inpatients at the ICU

September 8, 2023 updated by: University Hospital Ostrava

Standard vs Intensive Rehabilitation and Nutrition Regimen for Inpatients at the Intensive Care Unit

Older patients often suffer from multiple illnesses that require acute hospitalization. The goal of medical work is not only to save lives and heal acutely ill people but also to maintain physical fitness and self-sufficiency. In acutely hospitalized patients, the investigators often observe a decrease in muscle mass and strength, a deterioration in overall fitness with the need for long follow-up care, and sometimes permanent help with normal daily activities. An important part of the treatment of every acute patient is the emphasis on adequate nutrition and physical activity. The aim of this study is to determine the most appropriate intensity of exercise and diet that will be best for acute patients and will lead to the maintenance/improvement of physical fitness and thus shorten the length of hospitalization.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The goal of daily medical work is not only to save lives and cure acutely ill patients but also to maintain quality of life, minimize the risk of complications, and, in the ever-growing population of geriatric patients, to maintain functional ability and self-sufficiency. Acute diseases of the internal type are almost always associated with catabolism leading to proteolysis and exacerbation of malnutrition. Patients are then often observed to have loss of muscle strength and muscle mass, deterioration of fitness, and in geriatric patients, who often have limited functional reserve and loss of self-sufficiency with the need for long follow-up care and sometimes permanent assistance with activities of daily living.

In addition to treating the disease itself, it is important to provide adequate nutrition and to maintain muscle strength and subsequent self-sufficiency by activating patients and providing optimally targeted physiotherapy. Studies demonstrating the effect of intensive rehabilitation are very heterogeneous and often performed on a relatively small number of subjects. Also, the results of these studies and their meta-analyses are inconclusive. It cannot be clearly stated based on the current scientific knowledge that intensive rehabilitation influences important endpoints such as in-hospital mortality, length of hospital stay, or the incidence of nosocomial infections. Early rehabilitation in acutely ill patients does influence muscle mass, but these effects are rather short-term.3 The effect of nutrition itself, or of individual nutrients (vitamin D, hydroxymethyl butyrate, etc.) is well known, and recommendations for nutrition have been developed based on this scientific knowledge. There is very limited evidence for the benefit of combining intensive rehabilitation and nutrition at the same time. The investigators know from available work that this intervention increases muscle mass and improves self-sufficiency.

A very important and still evolving area of medicine is the gut microbiome. The number of bacteria in our digestive tract is approximately the same as the number of cells in our entire body. Some authors speak of the gut microbiome as a separate organ. Intestinal bacteria and their products have a proven effect on the immune system locally and systemically and influence a variety of metabolic processes (insulin sensitivity, appetite, lipid metabolism and storage, oxidative stress, influence on inflammation, etc.). Today, it is possible to talk about the gut-muscle axis and know that the composition of the gut microbiome influences muscle tissue and, conversely, physical activity has been shown to have a benefit on the gut microbiome.

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Czechia
    • Czech Republic
      • Ostrava, Czech Republic, Czechia, 70852
        • Recruiting
        • University Hospital Ostrava
        • Contact:

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • male and female
  • patient admitted to the Intensive Care Unit of the Department of Internal Medicine and Cardiology, University Hospital Ostrava, for an acute illness of an internal nature; patients admitted to another department of the hospital whose transfer to the above-mentioned ICU (intensive care unit) was carried out within 24 hours of the start of hospitalization may also be included
  • assumption of a minimum length of hospital stay of 5 days
  • ability to give informed consent
  • the patient has both lower limbs
  • the patient can receive fluids and liquid food orally

Exclusion Criteria:

  • patient admitted from another health care facility where he/she has been admitted for more than 48 hours
  • terminal stage of disease (tumor or non-tumor)
  • patient with neuromuscular disease (polymyositis, etc.)
  • severe chronic disease associated with severe maldigestion (e.g., patient on parenteral home nutrition)
  • patient is fully immobile for a long time

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard rehabilitation
patient exercises with physiotherapists, staff assists with normal activities during the day, activation, and mobilization in and out of bed according to the patient's ability.
Procedure: More intensive rehabilitation
Patient exercises with physiotherapists, staff assists with normal activities during the day, activation, and mobilization in and out of bed according to the patient's ability.
Experimental: More intensive rehabilitation
  • patient exercises with physiotherapists, staff assists with normal activities during the day, activation, and mobilization in and out of bed according to the patient's ability.
  • patient daily exercises using the rehabilitation device MOTOmed Letto 2 for a minimum of 5 days, maximum duration not limited, minimum duration of exercise 20 minuts once daily
  • exercise duration will be recorded daily and total time (in hours) at the end of the hospital stay
Procedure: More intensive rehabilitation
Patient exercises with physiotherapists, staff assists with normal activities during the day, activation, and mobilization in and out of bed according to the patient's ability.
Active Comparator: Standard nutrition
- nutrition determined by the attending physician according to recommendations for age, type of acute illness and comorbidities
Dietary supplement: More intensive nutrition

in addition, the patient will be administered hydroxymethylbutyrate at a dose of 3 g/day - in case of ONS indication (oral nutrition support, formerly "sipping") in this form (Ensure advance plus 2 times a day), in case of non-indication or impossibility or intolerance of this form then in the form of a food supplement (Myotec HMB). The minimum total dose delivered is 12 g/5 days.

  • in case of hypovitaminosis D and serum Ca concentration up to 3.0 mmol/l, vitamin D will be administered at a dose of 3000 IU/day - cumulative 15000 IU/5 days (missing dose can be given at the end of the cycle in one dose)
  • inclusion of probiotics in standard doses
Experimental: More intensive nutrition

determined by the attending physician according to recommendations for age, type of acute illness and comorbidity

- in addition, the patient will be administered hydroxymethylbutyrate at a dose of 3 g/day and in case of hypovitaminosis D and serum Ca concentration up to 3.0 mmol/l, vitamin D will be administered at a dose of 3000 IU/day for 5 days
Dietary supplement: More intensive nutrition

in addition, the patient will be administered hydroxymethylbutyrate at a dose of 3 g/day - in case of ONS indication (oral nutrition support, formerly "sipping") in this form (Ensure advance plus 2 times a day), in case of non-indication or impossibility or intolerance of this form then in the form of a food supplement (Myotec HMB). The minimum total dose delivered is 12 g/5 days.

  • in case of hypovitaminosis D and serum Ca concentration up to 3.0 mmol/l, vitamin D will be administered at a dose of 3000 IU/day - cumulative 15000 IU/5 days (missing dose can be given at the end of the cycle in one dose)
  • inclusion of probiotics in standard doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay/hours
Time Frame: Through study completion, an average of 2 years
To compare length of hospital stay (primary endpoint = length of hospital stay/hours) in four patient groups - standard RHB (rehabilitation) and standard nutritional care (SS-1), standard RHB + intensive nutritional care (SI-2), intensive RHB and standard nutritional care (IS-3) and intensive RHB + intensive nutritional care (II-4).
Through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nosocomial infections during hospitalization.
Time Frame: Through study completion, an average of 2 years
Incidence of nosocomial infection during hospitalization (Y/N).
Through study completion, an average of 2 years
Rehospitalization within 3 months after discharge.
Time Frame: Rehospitalization within 3 months of discharge of hospital.
Rehospitalization within 3 months of discharge of hospital (Y/N).
Rehospitalization within 3 months of discharge of hospital.

Collaborators and Investigators

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

Sponsor

University Hospital Ostrava

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

March 10, 2022

Primary Completion (Estimated)

January 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

September 23, 2021

First Submitted That Met QC Criteria

January 26, 2022

First Posted (Actual)

January 27, 2022

Study Record Updates

Last Update Posted (Actual)

September 11, 2023

Last Update Submitted That Met QC Criteria

September 8, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22/RVO-FNOs/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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