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

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05096013
• Other study ID #: 2021-01824
• Status: Completed
• Phase: N/A
• Start date: November 16, 2021
• Est. completion date: January 14, 2024

Study information

• Verified date: March 2024
• Source: Berner Reha Zentrum AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 14, 2024
• Est. primary completion date: January 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition
• Sarcopenia

Intervention

Other:
• individual nutritional therapy
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.

Locations

Country	Name	City	State
Switzerland	Berner Reha Zentrum	Heiligenschwendi	Bern

Sponsors (2)

Lead Sponsor	Collaborator
Thimo Marcin	Bern University of Applied Sciences

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Energy intake	Change in energy intake [kcal] from start to end of rehabilitation.	From admission to discharge (2-3 weeks)
Secondary	protein intake	Change in protein intake [g] from start to end of rehabilitation.	From admission to discharge (2-3 weeks)
Secondary	grip strength	Change in grip strength (muscle strength) from start to end of rehabilitation.	From admission to discharge (2-3 weeks)
Secondary	lean body mass	Change in lean body mass (muscle mass) from start to end of rehabilitation.	From admission to discharge (2-3 weeks)
Secondary	time up and go	Change in time up an go time (muscle function) from start to end of rehabilitation	From admission to discharge (2-3 weeks)