Clinical trial NCT03845309: Nutritional Interventions in Chronic Heart Failure
Official title: The Effect of Using Nutrition Education as an Intervention Measure on Elevating the Nutritional Status, Quality of Life, and Self-Care Behavior of Patients With Chronic Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Heart Failure
Nutrition
Keywords: Heart failure
Nutritional intervention
Quality of Life
Self-Care Behavior
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2019-02-19
Enrollment: 95
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study recruited patients diagnosed with heart failure by cardiologists and cardiac outpatients whose cardiac functions were graded from 1 to 4 according to the New York Heart Association as the study participants. The participants were provided active nutrition intervention including diet optimization,specific recommendations and nutritional supplement prescriptions in cases in which nutritional goals were not reached.In addition, this study offered advice by referencing lifestyle change advice provided by the American Heart Association for patients with heart failure.

The Mini Nutritional Assessment Short-Form was used to assess malnutrition indicator values. The participant water, nutrient (i.e., carbohydrates, protein, and fat), and calorie intake data were collected using their recollection of their dietary intake and food intake frequency over a 24-hour dietary recall. The amount of fluid and sodium administered was provided according to the cardiac function grades indicated by the New York Heart Association.In addition, dietary assessments and nutritional advice were offered on the basis of the patients' conditions (i.e., age, activity, and comorbidity).

Finally, instrumental activities of daily living, EQ-5D (an instrument for measuring quality of life), grip performance, and 6-minute walk test data were utilized to analyze the changes in the participants before and after intervention, identifying the correlation between using nutrition education as an intervention measure and improvement in the participants' nutritional status, quality of life, and self-care behavior.

Detailed description: Malnutrition may be caused by decreased nutrient intake or absorption, inflammation, or other disease-related mechanisms. Malnutrition resulting from disease or injury may be caused by decreased food intake or varying degrees of acute or chronic inflammation, which alters body composit ion and prompts a decline in biological functions. The effects of decreased food intake induced by an inflammatory reaction are related to the malnourishment resulted from anorexia, changes in metabolism, increased resting energy expenditure, and increased muscle catabolism. Changes in body composition are characterized by a decrease in any muscle mass marker (excluding fat mass, muscle mass index, or body cell mass). Therefore, malnutrition is associated with clinical results of clinical malfunction.

The primary objectives of heart failure treatment include preventing the need for hospitalization, increasing the survival rate, and improving health status. Patient symptoms, bodily functions, and health status are also referred to as health-related quality of life (HRQoL). The EuroQol-5D (EQ-5D) is used to assess the quality of life of patients undergoing cardiac rehabilitation. This assessment uses 5 aspects, namely mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, to assess patient health status.

Cardiopulmonary exercise testing (CPET) is the gold standard method for evaluating the motor ability of patients with chronic heart failure (CHF), yet is not extensively used. A more commonly used and simpler method is the 6-minute walk test, which measures the distance traveled by walking for 6 minutes. Changes in this value correlate to quality of life. This test is used to investigate the ability to perform daily activities and intensity of exercise in patients with mild to moderate CHF.

Muscle strength is a key indicator for assessing patients with sarcopenia because decreased muscle strength is considered a crucial element in diagnosing muscle reduction. For circumstances in which muscle mass is difficult to assess, muscle strength, such as handgrip strength, can serve as a standard assessment of muscle functions.

Exercise training is considered a valid method for stabilizing patients with heart failure. One study reported that the self-management intervention of a patient with heart failure notably decreased the occurrence of hospitalization and hospital readmission related to heart failure as well as all-cause mortality.

The present study determines the effectiveness of nutrition intervention in routine medical treatment for improving the nutrition and quality of care among patients with heart failure.

This study does not involve drugs, medical technology, or medical equipment.

Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with CHF by a cardiologist. Clinical patients with the functional classification of NYHA FcI-NYHA FcⅣ according to the New York Heart Association (NYHA).
2. Adults aged 20 years or older who are conscious, have normal cognitive function, can walk without assistance, and do not require breathing aids. Additionally, participants must be able to answer questionnaires in Mandarin Chinese or Taiwanese, either orally or in writing.
3. Patients who have agreed to participate in the study by completing a consent form.

Exclusion Criteria:

1. Patients with an expected survival period of less than 6 months because of a disease not related to CHF
2. Long-term bed-bound patients
3. Patients with no potential for rehabilitation because of decline in functions of neural or musculoskeletal systems
4. Patients with severe disorders of consciousness or cognitive disorders or those with mental illness
5. Patients who require breathing aids for an extended period of time
6. Patients with end-stage severe CHF who have been diagnosed by doctors as unable to recover within a short period
7. Patients who are scheduled to undergo coronary artery bypass surgery or a heart valve surgery within 1 month
8. Patients who are on hemodialysis or are awaiting a kidney transplant
9. Patients with severe pulmonary diseases who require long-term home oxygen therapy
10. Patients who themselves decline to participate or who have a family member who objects to their participation.

Primary outcomes:
measure: Mini Nutritional Assessment Short-Form
timeFrame: Change from Baseline Mini Nutritional Assessment Short-Form on months 0, 3 at 6 months(Do higher values represent a better outcome).
measure: Instrumental Activities of Daily Living
timeFrame: Change from Baseline Instrumental Activities of Daily Living on months 0, 3 at 6 months.
measure: EuroQol-5D
timeFrame: Change from Baseline EuroQol-5D on months 0, 3 at 6 months(Do higher values represent a better outcome).
measure: Handgrip strength
timeFrame: Change from Baseline Handgrip strength on months 0, 3 at 6 months.
measure: 6-Minute walk test
timeFrame: Change from Baseline 6-Minute walk test on months 0, 3 at 6 months(Do higher values represent a better outcome).
Secondary outcomes:
measure: Energy intake
timeFrame: Change from Baseline Energy intake on months 0, 3 at 6 months.
measure: Carbohydrate intake
timeFrame: Change from Baseline Carbohydrate intake on months 0, 3 at 6 months.
measure: Protein intake
timeFrame: Change from Baseline Protein intake on months 0, 3 at 6 months.
measure: Fat intake
timeFrame: Change from Baseline Fat intake on months 0, 3 at 6 months.
measure: Sodium intake
timeFrame: Change from Baseline Sodium intake on months 0, 3 at 6 months.
measure: Water intake
timeFrame: Change from Baseline Water intake on months 0, 3 at 6 months.
Other outcomes:
Locations:
city: Douliu
country: Taiwan
facility: Department of Internal Medicine, National Taiwan Univeristy Hospital Yun-Lin branch
state: Yunlin County
Study officials:
affiliation: National Taiwan University Hospital Yunlin Branch
name: Jien-Jiun Chen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Taiwan University Hospital Yunlin Branch
name: Feng-Ching Liao, BS
role: PRINCIPAL_INVESTIGATOR
affiliation: National Taiwan University Hospital Yunlin Branch
name: Sheng Nan Chang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Taiwan University Hospital Yunlin Branch
name: Shao-Chi Yang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Taiwan University Hospital Yunlin Branch
name: Chih-Neng Hsu, MD
role: PRINCIPAL_INVESTIGATOR
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