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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05096013
Enrollment
60
Registered
2021-10-27
Start date
2021-11-16
Completion date
2024-01-14
Last updated
2024-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malnutrition, Sarcopenia

Keywords

individual nutrition therapy

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.

Interventions

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.

Sponsors

Bern University of Applied Sciences
CollaboratorOTHER
Thimo Marcin
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)

Masking description

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.

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Energy intakeFrom admission to discharge (2-3 weeks)Change in energy intake \[kcal\] from start to end of rehabilitation.

Secondary

MeasureTime frameDescription
protein intakeFrom admission to discharge (2-3 weeks)Change in protein intake \[g\] from start to end of rehabilitation.
grip strengthFrom admission to discharge (2-3 weeks)Change in grip strength (muscle strength) from start to end of rehabilitation.
lean body massFrom admission to discharge (2-3 weeks)Change in lean body mass (muscle mass) from start to end of rehabilitation.
time up and goFrom admission to discharge (2-3 weeks)Change in time up an go time (muscle function) from start to end of rehabilitation

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026