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

NCT05096013 | Completed DMC

• 1 other identifier: 2021-01824
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sarcopenia; Malnutrition

Keywords

individual nutrition therapy

Outcome Measures

Primary Outcomes (1)

• Energy intake

  Change in energy intake \[kcal\] from start to end of rehabilitation.

  From admission to discharge (2-3 weeks)

Secondary Outcomes (4)

• protein intake

  From admission to discharge (2-3 weeks)

• grip strength

  From admission to discharge (2-3 weeks)

• lean body mass

  From admission to discharge (2-3 weeks)

• time up and go

  From admission to discharge (2-3 weeks)

Study Arms (2)

individual nutrition therapy

EXPERIMENTAL

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

usual care

NO INTERVENTION

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.

Interventions

individual nutritional therapy OTHER

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.

individual nutrition therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Thimo Marcin: lead
• Bern University of Applied Sciences: collaborator

Study Sites (1)

Berner Reha Zentrum

Heiligenschwendi, Canton of Bern, 3625, Switzerland

Location

Related Publications (1)

• Coiro M, Zurfluh A, Lehmann U, Brun P, Scheel-Sailer A, Tschanz H, van Hoof A, Wilhelm M, Marcin T. Effect of individual nutritional therapy during inpatient pulmonary rehabilitation in patients at risk for malnutrition and sarcopenia - a randomized controlled trial. Chron Respir Dis. 2025 Jan-Dec;22:14799731251350692. doi: 10.1177/14799731251350692. Epub 2025 Jun 15.

  PMID: 40518743 DERIVED

MeSH Terms

Conditions

Sarcopenia; Malnutrition

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Patients cannot be blinded due to the nature of the intervention. However, the personnel involved will be blinded to the collection of the primary endpoint. In order to be able to blind the nutritional calculations of the primary endpoint, the logged amounts of food eaten will be recorded on the neutral eating cards, on which the study group allocation will not be apparent.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Reseach Department

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: October 27, 2021
• Study Start: November 16, 2021
• Primary Completion: January 14, 2024
• Study Completion: January 14, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 2022, July

Locations

CH (1)