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

Sponsor
Thimo Marcin (Other)
Overall Status
Recruiting
CT.gov ID
NCT05096013
Collaborator
Bern University of Applied Sciences (Other)
60
1
2
7.7
7.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: individual nutritional therapy
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.
Primary Purpose:
Supportive Care
Official Title:
Effect of Individual Nutritional Therapy in Patients at Risk for Malnutrition and Sarcopenia in Pulmonary Rehabilitation - a Randomized Controlled Trial
Actual Study Start Date :
Nov 16, 2021
Anticipated Primary Completion Date :
Mar 20, 2022
Anticipated Study Completion Date :
Jul 8, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: individual nutrition therapy

Individualized nutrition therapy: Specialists in nutritional counseling determine the patient's individual energy and protein needs and create targeted individual measures to achieve them. Measures can include, for example, adjustments to the menu, food enrichment or supplementation. The measures are discussed with the patients on an ongoing basis and adjusted as necessary.

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.

No Intervention: usual care

Usual care: Participants in the control group receive a standardized food fortification of the soups with fat and protein, as well as an energy- and protein-rich dessert. No additional advice or adjustments are made by the iNT.

Outcome Measures

Primary Outcome Measures

  1. Energy intake [From admission to discharge (2-3 weeks)]

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

Secondary Outcome Measures

  1. protein intake [From admission to discharge (2-3 weeks)]

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

  2. grip strength [From admission to discharge (2-3 weeks)]

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

  3. lean body mass [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 [From admission to discharge (2-3 weeks)]

    Change in time up an go time (muscle function) from start to end of rehabilitation

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Berner Reha Zentrum Heiligenschwendi Bern Switzerland 3625

Sponsors and Collaborators

  • Thimo Marcin
  • Bern University of Applied Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Thimo Marcin, Head of Reseach Department, Berner Reha Zentrum AG
ClinicalTrials.gov Identifier:
NCT05096013
Other Study ID Numbers:
  • 2021-01824
First Posted:
Oct 27, 2021
Last Update Posted:
Nov 24, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Thimo Marcin, Head of Reseach Department, Berner Reha Zentrum AG
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 24, 2021