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

Sponsor

University Hospital Ostrava (Other)

Overall Status

Recruiting

CT.gov ID

NCT05209763

Collaborator

(none)

500

Enrollment

Location

Arms

45.7

Anticipated Duration (Months)

10.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Nutrition Disorders	Procedure: More intensive rehabilitation Dietary Supplement: More intensive nutrition	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective, randomised, 2x2 factorial design, angle centre interventional study with randomisation 1:1:1:1Prospective, randomised, 2x2 factorial design, angle centre interventional study with randomisation 1:1:1:1

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Mar 10, 2022

Anticipated Primary Completion Date :

Jan 31, 2024

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Length of hospital stay/hours [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).

Secondary Outcome Measures

Nosocomial infections during hospitalization. [Through study completion, an average of 2 years]
Incidence of nosocomial infection during hospitalization (Y/N).
Rehospitalization within 3 months after discharge. [Rehospitalization within 3 months of discharge of hospital.]
Rehospitalization within 3 months of discharge of hospital (Y/N).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Ostrava	Ostrava	Czech Republic	Czechia	70852

Sponsors and Collaborators

University Hospital Ostrava

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

University Hospital Ostrava

ClinicalTrials.gov Identifier:

NCT05209763

Other Study ID Numbers:

22/RVO-FNOs/2021

First Posted:

Jan 27, 2022

Last Update Posted:

Mar 14, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital Ostrava

Additional relevant MeSH terms:

Nutrition Disorders

Study Results

No Results Posted as of Mar 14, 2022