Clinical trial NCT04873856: Multidimensional Individualized Nutritional Therapy for Individuals with Severe COPD
Official title: Multidimensional INDividualized NUTritional Therapy for Individuals with Severe Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic obstructive pulmonary disease
Health-related quality of life
Nutrition
Mental health
Functional capacity
Anthropometry
Lead sponsor: Nordsjaellands Hospital
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
name: University of Copenhagen
First posted: 2021-05-05
Enrollment: 87
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 cost and poor prognosis. COPD is a complex and progressive disease with changing clinical states that influences nutritional status and quality of life in different ways. The primary aim is to improve quality of life for individuals with severe COPD.

120 individuals are recruited from the outpatient clinic at Nordsjællands Hospital in Denmark to a randomized controlled trial with two parallel groups (intervention and control). The intervention will last for 3 months comprising four elements including nutritional plan, regular contact, informal caregiver/friendly reminder and a weight dairy.

We expect that the intervention will improve quality of life, nutritional status and prognosis.


Eligibility criteria: Inclusion Criteria:

* ≥ 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 Criteria:

* 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).

Primary outcomes:
measure: Health-related quality of life
timeFrame: 1 and 3 months after baseline
Secondary outcomes:
measure: Weight
timeFrame: 1 and 3 months after baseline
measure: Body mass index
timeFrame: 1 and 3 months after baseline
measure: Hand grip strength
timeFrame: 1 and 3 months after baseline
measure: Lower body strength
timeFrame: 1 and 3 months after baseline
measure: Number of unplanned acute hospitalizations
timeFrame: 1 and 3 months after baseline
measure: Number of days in hospital
timeFrame: 1 and 3 months after baseline
measure: Number of acute unplanned visits to emergency ward (<6 hours)
timeFrame: 1 and 3 months after baseline
measure: Number of contacts to outpatient clinic (visits and phone calls)
timeFrame: up to 3 months after baseline
measure: Disease specific quality of life
timeFrame: 1 and 3 months after baseline
measure: Mortality
timeFrame: up to 3 months after baseline
measure: Fat-free mass
timeFrame: 1 and 3 months after baseline
measure: Fat mass
timeFrame: 1 and 3 months after baseline
Other outcomes:
measure: Total protein intake
timeFrame: 1 and 3 months after baseline
measure: Difference in protein requirement and protein intake
timeFrame: 1 and 3 months after baseline
measure: Total energy intake
timeFrame: 1 and 3 months after baseline
measure: Difference in energy requirement and energy intake
timeFrame: 1 and 3 months after baseline
measure: Upper arm circumference
timeFrame: 1 and 3 months after baseline
measure: Hip circumference
timeFrame: 1 and 3 months after baseline
measure: Waist circumference
timeFrame: 1 and 3 months after baseline
measure: Number of exacerbations
timeFrame: 1 and 3 months after baseline
measure: Oxygen therapy
timeFrame: 1 and 3 months after baseline
measure: Anxiety and depression
timeFrame: 1 and 3 months
measure: Physical activity (subjective)
timeFrame: 1 and 3 months after baseline
measure: Physical activity (objective)
timeFrame: 7 days from 1- months follow-up and 7 days from 3 months follow-up
Locations:
city: Hillerød
country: Denmark
facility: Nordsjællands Hospital
Study officials:
affiliation: Department of Pulmonary and Infectious Diseases, Nordsjællands Hospital, 3400 Hillerød, Denmark
name: Birgitte Lindegaard, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: