Clinical trial NCT05096013: Nutritional Therapy in Patients at Risk for Malnutrition and Sarcopenia in Pulmonary Rehabilitation
Official title: Effect of Individual Nutritional Therapy in Patients at Risk for Malnutrition and Sarcopenia in Pulmonary Rehabilitation - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Malnutrition
Keywords: individual nutrition therapy
Lead sponsor: Berner Reha Zentrum AG
Sponsor class: OTHER
Collaborators: name: Bern University of Applied Sciences
First posted: 2021-10-27
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Energy intake
timeFrame: From admission to discharge (2-3 weeks)
Secondary outcomes:
measure: protein intake
timeFrame: From admission to discharge (2-3 weeks)
measure: grip strength
timeFrame: From admission to discharge (2-3 weeks)
measure: lean body mass
timeFrame: From admission to discharge (2-3 weeks)
measure: time up and go
timeFrame: From admission to discharge (2-3 weeks)
Other outcomes:
Locations:
city: Heiligenschwendi
country: Switzerland
facility: Berner Reha Zentrum
state: Bern
Study officials:
References: