An interventional study of Intervention in Chronic Obstructive Pulmonary Disease, sponsored by Nordsjaellands Hospital. Completed at 1 site in Denmark. Open to participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2024-11-18.
Sponsored by Nordsjaellands Hospital · Not applicable, Interventional, and Supportive care
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.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 87 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
Browse Lung Diseases studies →Nordsjaellands Hospital is the lead sponsor of 88 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Intervention contains: 1. individual nutritional plan 2. regular contact 3. friendly reminder/informal caregiver and 4. weight dairy.
Dietary Supplement: Intervention
Standard of care
The four dimensions of MINDNUT are described below: Nutritional plan: is conducted in collaboration with the participant based on nutritional registration and information about routines and habits to reach a daily protein target of 1.5 g/kg/day. The nutritional plan is adjusted at the regular contact, and nutritional supplementation will be handed out to the participant. Friendly reminder/informal caregiver: is a friendly reminder that encourage the participant to follow the nutritional plan and to ask for support (a note to hang on the refrigerator). The informal caregiver is a person with close contact to the participant. Regular contacts: The participant will be contacted on regular basis (with an interval of 7-14 days) via phone and besides nutritional plan, this conversation will be used to talk about well-being, compliance and potential side-effects. Weight diary: participants is instructed in keeping a weight diary which include registration of a daily weight.
Health-related quality of life
Will be measured using the EQ-5D-5L
Time frame: 1 and 3 months after baseline
Weight
Measured using an electronic scale (TANITA DC 430 SMA, TANITA, Denmark) to the nearest 0.1 kg
Time frame: 1 and 3 months after baseline
Body mass index
Calculated as weight (kg)/height (m2)
Time frame: 1 and 3 months after baseline
Hand grip strength
Measured using handdynanometer
Time frame: 1 and 3 months after baseline
Lower body strength
Measured using 30 second stand chair test
Time frame: 1 and 3 months after baseline
Number of unplanned acute hospitalizations
Obtained from patient files
Time frame: 1 and 3 months after baseline
Number of days in hospital
Obtained from patient files
Time frame: 1 and 3 months after baseline
Number of acute unplanned visits to emergency ward (<6 hours)
Obtained from patient files
Time frame: 1 and 3 months after baseline
Number of contacts to outpatient clinic (visits and phone calls)
Obtained from patient files
Time frame: up to 3 months after baseline
Disease specific quality of life
Obtained using COPD Assessment test (CAT). CAT contains 8 items with a scoring range of 0-40. The total score indicate the impact level COPD has on the everyday life ranging from low to very high. A total score of 5 is referred to the upper limit of normal in healthy non-smokers, a total score \<10 indicate low impact, 10-20 indicate medium impact, whereas \>20 and \>30 indicate high and very high impact, respectively.
Time frame: 1 and 3 months after baseline
Mortality
will be obtained from patient files
Time frame: up to 3 months after baseline
Fat-free mass
Measured using bioelectrical impedance analysis
Time frame: 1 and 3 months after baseline
Fat mass
Measured using bioelectrical impedance analysis
Time frame: 1 and 3 months after baseline
Total protein intake
Measured through 24-recall and calculated using MADlog (MADLOG, Denmark) in grams
Time frame: 1 and 3 months after baseline
Difference in protein requirement and protein intake
Intake measured through 24-recall and calculated using MADlog (MADLOG, Denmark) in grams adnd requirements is calculated as 1.5 g/kg/day.
Time frame: 1 and 3 months after baseline
Total energy intake
Measured through 24-recall and calculated using MADlog (MADLOG, Denmark) in kalories.
Time frame: 1 and 3 months after baseline
Difference in energy requirement and energy intake
Intake measured through 24-recall and calculated using MADlog (MADLOG, Denmark) in kalories. Requirements calculated as 30 kcal/kg/day if goal is weight maintenance and 45 kcal kg/day if goal is weight gain
Time frame: 1 and 3 months after baseline
Upper arm circumference
Measured using a measuring tape to the nearest 0.1 cm
Time frame: 1 and 3 months after baseline
Hip circumference
Measured using a measuring tape to the nearest 0.1 cm
Time frame: 1 and 3 months after baseline
Waist circumference
Measured using a measuring tape to the nearest 0.1 cm
Time frame: 1 and 3 months after baseline
Number of exacerbations
Obtained from patient files supplemented with self-reported information
Time frame: 1 and 3 months after baseline
Oxygen therapy
Self-reported. The participant is asked if he/she is currently using home oxygen.
Time frame: 1 and 3 months after baseline
Anxiety and depression
Measured using Hospital Anxiety and Depression Scale. The scale contains two subscales to evaluate risk of anxiety and depression. Each subscale contains 7 items with a total score from 0-21. Risk of anxiety and depression are based on a total score ≥8.
Time frame: 1 and 3 months
Physical activity (subjective)
Measured using the physical activity and vial signs questionnaire
Time frame: 1 and 3 months after baseline
Physical activity (objective)
Measured using accelerometers (Activity AX3, Newcastle, United Kingdom)
Time frame: 7 days from 1- months follow-up and 7 days from 3 months follow-up
Plan to share: No
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Nordsjaellands Hospital