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Completed

NCT Number: NCT05096013

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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Berner Reha Zentrum

Heiligenschwendi, Canton of Bern, 3625, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Energy intake

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

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

Secondary outcomes

  1. protein intake

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

    Change in protein intake [g] from start to end of rehabilitation.

  2. grip strength

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

    Change in grip strength (muscle strength) from start to end of rehabilitation.

  3. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

Thimo Marcin

Other

Collaborators

  • Bern University of Applied Sciences

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Oct 27, 2021
Registry last updated
Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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