Nutritional Therapy in Patients at Risk for Malnutrition and Sarcopenia in Pulmonary Rehabilitation

March 12, 2024 updated by: Thimo Marcin

Effect of Individual Nutritional Therapy in Patients at Risk for Malnutrition and Sarcopenia in Pulmonary Rehabilitation - a Randomized Controlled Trial

Malnutrition and sarcopenia (muscle wasting) are common in health care settings and represent a health and economic burden due to associated increased mortality and prolonged hospital stays. Nutritional therapy co-management is recommended for both diagnoses.

This study investigates the efficacy of individualized nutrition therapy (iNT) in pulmonary rehabilitation. Patients at significant risk for malnutrition already receive iNT within clinical routine during rehabilitation. The investigators will investigate if patients with only mild to moderate risk of malnutrition and possible sarcopenia also benefit from iNT.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The participating patients are randomly assigned to two groups after giving written consent.

The intervention group receives individual counseling by nutrition therapists twice a week in addition to the usual rehabilitation program. The iNT determines the energy and protein needs of the patients and creates targeted individual measures to achieve them. Measures may include, for example, adjustments to the meal plan or nutritional supplementation. The measures are continuously adapted to the patients' needs.

The control group also receives soup fortified with a standard amount of protein and fat and, if needed, an energy- and protein-rich dessert option as part of the rehabilitation routine care for patients at risk for malnutrition. However, patients from the control group do not receive additional counseling or adjustment by the iNT.

Patients' energy and protein intake will be recorded on three subsequent days at start of rehabilitation and at three subsequent days before discharge. Average duration of rehabilitation is expected to be three weeks. As primary outcome, change in energy intake will be compared between groups. Additionally, change in protein intake and other follow-up parameters of nutritional status and sarcopenia will be examined.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Switzerland
    • Bern
      • Heiligenschwendi, Bern, Switzerland, 3625
        • Berner Reha Zentrum

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • admission to rehab due to chronic obstructive pulmonary disease or after a pneumonia
  • light to moderate risk of malnutrition (Nutritional Risk Score-2002: 3-4 Points)
  • risk of sarcopenia (sarc-f >=4)
  • signed informed consent

Exclusion Criteria:

  • medically described nutritional support
  • reasons (cognitive, language) that prevent a informed consent
  • enteral or parenteral nutrition
  • after bariatric surgery

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: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: individual nutrition therapy
Individualized nutrition therapy: Specialists in nutritional counseling determine the patient's individual energy and protein needs and create targeted individual measures to achieve them. Measures can include, for example, adjustments to the menu, food enrichment or supplementation. The measures are discussed with the patients on an ongoing basis and adjusted as necessary.
Other: individual nutritional therapy
Intervention arm: Usual care + individualized nutritional therapy. Patients at risk for malnutrition and sarcopenia will receive a counselling by the nutritional therapist twice a week. The therapists will assess the patient's energy and protein demand in order to develope appropriate individual measures (e.g additional meals or supplements) to increase patients' energy and protein intake. Individual nutritional therapy is already usual care in patients with high risk for malnutrition, but not for patients with only light to moderate risk of malnutrition and risk of sarcopenia.
No Intervention: usual care
Usual care: Participants in the control group receive a standardized food fortification of the soups with fat and protein, as well as an energy- and protein-rich dessert. No additional advice or adjustments are made by the iNT.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Energy intake
Time Frame: From admission to discharge (2-3 weeks)
Change in energy intake [kcal] from start to end of rehabilitation.
From admission to discharge (2-3 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
protein intake
Time Frame: From admission to discharge (2-3 weeks)
Change in protein intake [g] from start to end of rehabilitation.
From admission to discharge (2-3 weeks)
grip strength
Time Frame: From admission to discharge (2-3 weeks)
Change in grip strength (muscle strength) from start to end of rehabilitation.
From admission to discharge (2-3 weeks)
lean body mass
Time Frame: From admission to discharge (2-3 weeks)
Change in lean body mass (muscle mass) from start to end of rehabilitation.
From admission to discharge (2-3 weeks)
time up and go
Time Frame: From admission to discharge (2-3 weeks)
Change in time up an go time (muscle function) from start to end of rehabilitation
From admission to discharge (2-3 weeks)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Thimo Marcin

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bern University of Applied Sciences

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 16, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 14, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 14, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 5, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 27, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021-01824

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

IPD Sharing Time Frame

2022, July

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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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