The Effect of Nutrition and BMI on on Lung Capacity, Functional Capacity and Mortality in End-Stage Lung Patients

The Effect of Nutritional Status and Body Mass Index on Lung Capacity, Functional Capacity and Mortality in End-Stage Lung Patients on the Lung Transplant List

The aim of this study was to investigate the effect of nutritional risk index, BMI and body fat, muscle ratio on functional capacity, lung capacity, exercise capacity index, all-cause mortality, post-transplant intensive care unit stay and survival time in end-stage lung patients on the lung transplant list.

Study Overview

• Status: Active, not recruiting
• Conditions: Lung Transplant
• Intervention / Treatment: Procedure: Lung transplantation

Detailed Description

This study aimed to determine the nutritional status of patients awaiting lung transplantation and examine the effects of nutritional status, immunonutrition use, and BMI on lung capacity, mortality, and health status after lung transplantation. The study was designed in two different periods. The first period was a retrospective descriptive study. During this study, we will examine the retrospective nutritional status of patients who are waiting for lung transplantation, those who exited while on the list, or those who have received lung transplantation. In the second phase, we will conduct face-to-face interviews with patients on the lung transplant list, take bioelectrical impedance analyses (BIA), and record 24-hour food consumption to examine their detailed nutritional status.

• Study Type: Observational
• Enrollment (Estimated): 213

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • OkanU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The population of the study consisted of patients who applied to the lung transplantation outpatient clinic at Koşuyolu High Specialised Training and Research Hospital between 2016 and 2022, were listed, were waiting on the list, died while on the list, and received lung transplantation, and met the inclusion criteria.

Description

Inclusion Criteria:

1. End-stage lung disease
2. To be on the Lung Transplant list.
3. Being between the ages of 19-65
4. Not having severe psychiatric illness
5. Being fed orally
6. Volunteering to participate in the study for Patients Waiting on the Transplant List

Exclusion Criteria:

1. To be removed from the Lung Transplant List
2. Being pregnant or lactating
3. Severe psychiatric illness
4. Peg or Jeg feeding (unable to feed orally)
5. Missing data in the file

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Ex patients on the lung transplant waiting list	Procedure: Lung transplantation; Three different groups will be investigated with respect to the effect of NRI, BMI and body fat, muscle ratio on functional capacity, lung capacity, exercise capacity index, all-cause mortality, post-transplant intensive care unit stay and survival time in end-stage lung patients on the lung transplant list.
Group 2; Tansplant patients	Procedure: Lung transplantation; Three different groups will be investigated with respect to the effect of NRI, BMI and body fat, muscle ratio on functional capacity, lung capacity, exercise capacity index, all-cause mortality, post-transplant intensive care unit stay and survival time in end-stage lung patients on the lung transplant list.
Group 3; Patients waiting on the current list	Procedure: Lung transplantation; Three different groups will be investigated with respect to the effect of NRI, BMI and body fat, muscle ratio on functional capacity, lung capacity, exercise capacity index, all-cause mortality, post-transplant intensive care unit stay and survival time in end-stage lung patients on the lung transplant list.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI	BMI values are evaluated for the patients for patients waiting on the transplant list, transplanted and exited.	For one month period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutrition risk index	BMI values are evaluated for the patients for patients waiting on the transplant list, transplanted and exited.	For one month period.

Collaborators and Investigators

• Sponsor: Aylin Seylam Küşümler
• Collaborators: Koşuyolu Yüksek İhtisas Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2023
• Primary Completion (Estimated): April 28, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: February 21, 2024
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2024 (Other Grant/Funding Number: Rome Foundation)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No