Status:
COMPLETED
Multidimensional Individualized Nutritional Therapy for Individuals with Severe COPD
Lead Sponsor:
Nordsjaellands Hospital
Collaborating Sponsors:
Rigshospitalet, Denmark
University of Copenhagen
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
35+ years
Phase:
NA
Brief Summary
Individuals with severe chronic pulmonary disease often life isolated with a high burden of symptoms. Nutritional risk and low quality of life are common, and both associated with increased societal c...
Eligibility Criteria
Inclusion
- ≥ 35 years
- Severe COPD defined as GOLD grade 2 group B or D OR GOLD grade 3 and 4 group ABCD
- Able to eat orally
- Live in own home
- Speak Danish or English
- Undernourished OR at risk of undernutrition defined as BMI ≤ 21 kg/m2 if \< 70 years and BMI \<22 kg/m2 if ≥70 years OR BMI 21-25 kg/m2 plus nutritional risk (nutritional risk screening score ≥3) if \<70 years and BMI 22-25 kg/m2 plus nutritional risk if ≥70 years
- Stable phase
- CHANGE: Undernourished OR at risk of undernutrition (a maximum BMI of 25 kg/m2) determined by Nutritional Risk Screening 2002 or Mini Nutritional Assessment Short Form according to the protocol published in Trials.
Exclusion
- Active solid cancer" defined as cancer diagnosed within the previous six months, recurrent, regionally advanced, or metastatic cancer, cancer for which treatment had been administered within six months or hematological cancer that is not in complete remission
- Unable to sign informed consent e.g. due to severe dementia.
- Severe chronic renal failure defined as estimated glomerular filtration rate \< 30 mL/min./1.73 m2 (ICD-10 codes N18.4 and N18.5
- Severe alcohol abuse (ICD-10 codes F10.2 and K70.x).
Key Trial Info
Start Date :
May 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 14 2023
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT04873856
Start Date
May 21 2021
End Date
June 14 2023
Last Update
November 18 2024
Active Locations (1)
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1
Nordsjællands Hospital
Hillerød, Denmark, 3400