Nutrition DisordersNCT05209763
Standard vs Intensive Rehabilitation and Nutrition Regimen for Inpatients at the ICU
A study testing More intensive rehabilitation and More intensive nutrition in people with Nutrition Disorders, run by University Hospital Ostrava at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nutrition Disorders
- What is being tested?
- More intensive rehabilitation and More intensive nutrition
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteCzechia
- Study dates
- 10 Mar 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Ostrava
Ostrava, Czech Republic, 70852
Zdeněk Lys, M.D., +420736541342, zdenek.lys@fno.cz
About this study
Official title: 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.
Read the 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.
- Conditions
- Nutrition Disorders
- Being tested
- More intensive rehabilitation, More intensive nutrition
- Keywords
- Rehabilitation, Nutrition regimen, Intensive care, Internal medicine
- Medical subject headings
- Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
More intensive rehabilitationProcedure or surgery
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 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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 Receives: 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 Receives: Dietary Supplement: More intensive nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Through study completion, an average of 2 years
Secondary outcomes (2)
Nosocomial infections during hospitalization.
Incidence of nosocomial infection during hospitalization (Y/N).
Measured: Through study completion, an average of 2 years
Rehospitalization within 3 months after discharge.
Rehospitalization within 3 months of discharge of hospital (Y/N).
Measured: Rehospitalization within 3 months of discharge of hospital.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start10 Mar 2022
- Primary completion31 Jan 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Nutrition DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomised, 2x2 factorial design, angle centre interventional study with randomisation 1:1:1:1
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05209763
- Sponsor's protocol ID
- 22/RVO-FNOs/2021
- Status last verified
- Sep 2023
- First submitted
- 23 Sep 2021
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27864615Morris 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.
PubMed 27367766Fuke 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.
PubMed 29730622Kou 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.
PubMed 31548485Ticinesi 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.
PubMed 30753131Ticinesi 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.
PubMed 29189738Casati 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.
PubMed 31226349
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard vs Intensive Rehabilitation and Nutrition Regimen for Inpatients at the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT05209763
- Acronym / sponsor ID
- 22/RVO-FNOs/2021
- Conditions
- Nutrition Disorders
- Keywords
- Rehabilitation, Nutrition regimen, Intensive care, Internal medicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Prospective, randomised, 2x2 factorial design, angle centre interventional study with randomisation 1:1:1:1
| Arm | Type | Receives |
|---|---|---|
| Standard rehabilitation | Active comparator | Procedure: More intensive rehabilitationpatient 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 rehabilitation | Experimental | 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. * 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 |
| Standard nutrition | Active comparator | Dietary Supplement: More intensive nutrition- nutrition determined by the attending physician according to recommendations for age, type of acute illness and comorbidities |
| More intensive nutrition | Experimental | Dietary Supplement: More intensive nutritiondetermined 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| More intensive rehabilitationPatient 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 or surgery | More intensive rehabilitation, Standard rehabilitation |
| More intensive nutritionin 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 | Dietary supplement | More intensive nutrition, Standard nutrition |
Primary outcome
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).
2 secondary outcomes
Nosocomial infections during hospitalization.
Time frame: Through study completion, an average of 2 years
Rehospitalization within 3 months after discharge.
Time frame: Rehospitalization within 3 months of discharge of hospital.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Background: PubMed 27864615Tipping 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.
- Background: PubMed 27367766Morris 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.
- Background: PubMed 29730622Fuke 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.
- Background: PubMed 31548485Kou 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.
- Background: PubMed 30753131Ticinesi 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.
- Background: PubMed 29189738Ticinesi 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.
- Background: PubMed 31226349Casati 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing More intensive rehabilitation and More intensive nutrition in people with Nutrition Disorders, run by University Hospital Ostrava at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zdenek Lys, M.D. (1420736541342, zdenek.lys@fno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay/hours (time frame: Through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05209763, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2023.