search
Back to results

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

Primary Purpose

Nutrition Disorders

Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
More intensive rehabilitation
More intensive nutrition
Sponsored by
University Hospital Ostrava
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Nutrition Disorders focused on measuring Rehabilitation, Nutrition regimen, Intensive care, Internal medicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospital OstravaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

Standard rehabilitation

More intensive rehabilitation

Standard nutrition

More intensive nutrition

Arm Description

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 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

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

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

Outcomes

Primary Outcome Measures

Length of hospital stay/hours
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.
Incidence of nosocomial infection during hospitalization (Y/N).
Rehospitalization within 3 months after discharge.
Rehospitalization within 3 months of discharge of hospital (Y/N).

Full Information

First Posted
September 23, 2021
Last Updated
September 8, 2023
Sponsor
University Hospital Ostrava
search

1. Study Identification

Unique Protocol Identification Number
NCT05209763
Brief Title
Standard vs Intensive Rehabilitation and Nutrition Regimen for Inpatients at the ICU
Official Title
Standard vs Intensive Rehabilitation and Nutrition Regimen for Inpatients at the Intensive Care Unit
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2022 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Ostrava

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutrition Disorders
Keywords
Rehabilitation, Nutrition regimen, Intensive care, Internal medicine

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomised, 2x2 factorial design, angle centre interventional study with randomisation 1:1:1:1
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard rehabilitation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
More intensive rehabilitation
Arm Type
Experimental
Arm Description
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
Arm Title
Standard nutrition
Arm Type
Active Comparator
Arm Description
- nutrition determined by the attending physician according to recommendations for age, type of acute illness and comorbidities
Arm Title
More intensive nutrition
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
More intensive rehabilitation
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
More intensive nutrition
Intervention Description
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
Primary Outcome Measure Information:
Title
Length of hospital stay/hours
Description
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).
Time Frame
Through study completion, an average of 2 years
Secondary Outcome Measure Information:
Title
Nosocomial infections during hospitalization.
Description
Incidence of nosocomial infection during hospitalization (Y/N).
Time Frame
Through study completion, an average of 2 years
Title
Rehospitalization within 3 months after discharge.
Description
Rehospitalization within 3 months of discharge of hospital (Y/N).
Time Frame
Rehospitalization within 3 months of discharge of hospital.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zdenek Lys, M.D.
Phone
1420736541342
Email
zdenek.lys@fno.cz
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Vaclavik, prof.,M.D.
Phone
1420597375202
Email
jan.vaclavik@fno.cz
Facility Information:
Facility Name
University Hospital Ostrava
City
Ostrava
State/Province
Czech Republic
ZIP/Postal Code
70852
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zdeněk Lys, M.D.
Phone
+420736541342
Email
zdenek.lys@fno.cz

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27864615
Citation
Tipping CJ, Harrold M, Holland A, Romero L, Nisbet T, Hodgson CL. The effects of active mobilisation and rehabilitation in ICU on mortality and function: a systematic review. Intensive Care Med. 2017 Feb;43(2):171-183. doi: 10.1007/s00134-016-4612-0. Epub 2016 Nov 18.
Results Reference
background
PubMed Identifier
27367766
Citation
Morris PE, Berry MJ, Files DC, Thompson JC, Hauser J, Flores L, Dhar S, Chmelo E, Lovato J, Case LD, Bakhru RN, Sarwal A, Parry SM, Campbell P, Mote A, Winkelman C, Hite RD, Nicklas B, Chatterjee A, Young MP. Standardized Rehabilitation and Hospital Length of Stay Among Patients With Acute Respiratory Failure: A Randomized Clinical Trial. JAMA. 2016 Jun 28;315(24):2694-702. doi: 10.1001/jama.2016.7201.
Results Reference
background
PubMed Identifier
29730622
Citation
Fuke R, Hifumi T, Kondo Y, Hatakeyama J, Takei T, Yamakawa K, Inoue S, Nishida O. Early rehabilitation to prevent postintensive care syndrome in patients with critical illness: a systematic review and meta-analysis. BMJ Open. 2018 May 5;8(5):e019998. doi: 10.1136/bmjopen-2017-019998.
Results Reference
background
PubMed Identifier
31548485
Citation
Kou K, Momosaki R, Miyazaki S, Wakabayashi H, Shamoto H. Impact of Nutrition Therapy and Rehabilitation on Acute and Critical Illness: A Systematic Review. J UOEH. 2019;41(3):303-315. doi: 10.7888/juoeh.41.303.
Results Reference
background
PubMed Identifier
30753131
Citation
Ticinesi A, Lauretani F, Tana C, Nouvenne A, Ridolo E, Meschi T. Exercise and immune system as modulators of intestinal microbiome: implications for the gut-muscle axis hypothesis. Exerc Immunol Rev. 2019;25:84-95.
Results Reference
background
PubMed Identifier
29189738
Citation
Ticinesi A, Lauretani F, Milani C, Nouvenne A, Tana C, Del Rio D, Maggio M, Ventura M, Meschi T. Aging Gut Microbiota at the Cross-Road between Nutrition, Physical Frailty, and Sarcopenia: Is There a Gut-Muscle Axis? Nutrients. 2017 Nov 30;9(12):1303. doi: 10.3390/nu9121303.
Results Reference
background
PubMed Identifier
31226349
Citation
Casati M, Ferri E, Azzolino D, Cesari M, Arosio B. Gut microbiota and physical frailty through the mediation of sarcopenia. Exp Gerontol. 2019 Sep;124:110639. doi: 10.1016/j.exger.2019.110639. Epub 2019 Jun 18.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs