NCT05209763

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 27, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

March 10, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

September 11, 2023

Status Verified

September 1, 2023

Enrollment Period

1.9 years

First QC Date

September 23, 2021

Last Update Submit

September 8, 2023

Conditions

Nutrition Disorders

Keywords

RehabilitationNutrition regimenIntensive careInternal medicine

Outcome Measures

Primary Outcomes (1)

  • 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).

    Through study completion, an average of 2 years

Secondary Outcomes (2)

  • Nosocomial infections during hospitalization.

    Through study completion, an average of 2 years

  • Rehospitalization within 3 months after discharge.

    Rehospitalization within 3 months of discharge of hospital.

Study Arms (4)

Standard rehabilitation

ACTIVE COMPARATOR

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

More intensive rehabilitation

EXPERIMENTAL

* 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

Standard nutrition

ACTIVE COMPARATOR

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

Dietary Supplement: More intensive nutrition

More intensive nutrition

EXPERIMENTAL

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

Interventions

More intensive rehabilitationPROCEDURE

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.

More intensive rehabilitationStandard rehabilitation
More intensive nutritionDIETARY_SUPPLEMENT

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

More intensive nutritionStandard nutrition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ostrava

Ostrava, Czech Republic, 70852, Czechia

RECRUITING

Related Publications (7)

  • 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.

    PMID: 27864615BACKGROUND

  • 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.

    PMID: 27367766BACKGROUND

  • 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.

    PMID: 29730622BACKGROUND

  • 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.

    PMID: 31548485BACKGROUND

  • 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.

    PMID: 30753131BACKGROUND

  • 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.

    PMID: 29189738BACKGROUND

  • 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.

    PMID: 31226349BACKGROUND

MeSH Terms

Conditions

Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Central Study Contacts

Zdenek Lys, M.D.

CONTACT

1420736541342zdenek.lys@fno.cz

Jan Vaclavik, prof.,M.D.

CONTACT

1420597375202jan.vaclavik@fno.cz

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Prospective, randomised, 2x2 factorial design, angle centre interventional study with randomisation 1:1:1:1
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2021

First Posted

January 27, 2022

Study Start

March 10, 2022

Primary Completion

January 31, 2024

Study Completion

December 31, 2025

Last Updated

September 11, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)