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Clinical Trials/NCT05096013
NCT05096013
Completed
Not Applicable

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

Thimo Marcin1 site in 1 country60 target enrollmentNovember 16, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sarcopenia
Sponsor
Thimo Marcin
Enrollment
60
Locations
1
Primary Endpoint
Energy intake
Status
Completed
Last Updated
2 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
November 16, 2021
End Date
January 14, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Thimo Marcin
Responsible Party
Sponsor Investigator
Principal Investigator

Thimo Marcin

Head of Reseach Department

Berner Reha Zentrum AG

Eligibility Criteria

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

Outcomes

Primary Outcomes

Energy intake

Time Frame: From admission to discharge (2-3 weeks)

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

Secondary Outcomes

  • time up and go(From admission to discharge (2-3 weeks))
  • lean body mass(From admission to discharge (2-3 weeks))
  • grip strength(From admission to discharge (2-3 weeks))
  • protein intake(From admission to discharge (2-3 weeks))

Study Sites (1)

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