Nutritional Interventions in Chronic Heart Failure

Chronic Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03845309
• Other study ID #: 201810039RINA
• Status: Completed
• Phase: N/A
• Start date: February 19, 2019
• Est. completion date: December 13, 2020

Study information

• Verified date: December 2020
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: December 13, 2020
• Est. primary completion date: December 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Patients diagnosed with CHF by a cardiologist. Clinical patients with the functional classification of NYHA FcI-NYHA Fc? 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.

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure
• Nutrition

Intervention

Behavioral:
• Self-Care Behavior
Limitations on liquid and sodium intake will be established in accordance with the NYHA functional classification, and patients will be provided with dietary assessments and nutrition advice according to personal characteristics such as age, physical activity level, and comorbidities. Additionally, suggestions on lifestyle changes were provided by referring to the advice for patients with heart failure from the American Heart Association.

Locations

Country	Name	City	State
Taiwan	Department of Internal Medicine, National Taiwan Univeristy Hospital Yun-Lin branch	Douliu	Yunlin County

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (30)

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mini Nutritional Assessment Short-Form	Assess malnutrition indicator values. Nutrition status evaluated by the MNA correlates with energy and nutrient intakes as well as anthropometrics, hematologic, and biological nutrition parameters.; MNA has 4 sections: anthropometrics (BMI, weight loss, arm and calf circumference), general assessment (lifestyle, medication, mobility, presence of depression or dementia), dietary assessment (number of meals, food and fluid intake, autonomy of feeding), and subjective assessment (self-perception of health and nutrition).; The maximum score for the MNA-SF is 14, with scores =12 indicating satisfactory nutrition status and =11 indicating a risk of malnutrition.	Change from Baseline Mini Nutritional Assessment Short-Form on months 0, 3 at 6 months(Do higher values represent a better outcome).
Primary	Instrumental Activities of Daily Living	Instrumental Activities of Daily Living Heath-related quality of life. IADL Scale was developed to assess more complex activities (termed "instrumental activities of daily living") necessary for functioning in community settings (e.g., shopping, cooking, managing finances). The capacity to handle these complex functions normally is lost before basic "activities of daily living" (e.g., eating, bathing, toileting) which are measured by ADL scales. Therefore, assessing IADLS may identify incipient decline in older adults or other individuals who are otherwise capable and healthy.; It contains 8 items that are rated with a summary score from 0 (low functioning) to 8 (high functioning).; This scale can be administered through an interview or by a written questionnaire.	Change from Baseline Instrumental Activities of Daily Living on months 0, 3 at 6 months.
Primary	EuroQol-5D	Assess the quality of life of patients undergoing cardiac rehabilitation. the generic EuroQol fivedimensional questionnaire (EQ-5D) instrument are commonly referred to as value sets; an important distinction lies in whether the valuations are elicited from individuals with experience of the health state (experience-based values) or from individuals from the general population to whom the health states are described (hypothetical values).; 100 means the best health you can imagine.; 0 means the worst health you can imagine.	Change from Baseline EuroQol-5D on months 0, 3 at 6 months(Do higher values represent a better outcome).
Primary	Handgrip strength	Assessment of muscle functions. Measured by dynamometer, before and after intervention. We will compare the statistical properties of between baseline and after 0, 3 at 6 months intervention.	Change from Baseline Handgrip strength on months 0, 3 at 6 months.
Primary	6-Minute walk test	Changes in this value correlate to quality of life	Change from Baseline 6-Minute walk test on months 0, 3 at 6 months(Do higher values represent a better outcome).
Secondary	Energy intake	Energy intake (Kcal/day)will be assessed by dietary survey on 24-hour recall.	Change from Baseline Energy intake on months 0, 3 at 6 months.
Secondary	Carbohydrate intake	Carbohydrate intake (g / day) will be assessed by dietary survey on 24-hour recall.	Change from Baseline Carbohydrate intake on months 0, 3 at 6 months.
Secondary	Protein intake	Protein intake (g / day) will be assessed by dietary survey on 24-hour recall.	Change from Baseline Protein intake on months 0, 3 at 6 months.
Secondary	Fat intake	Fat intake (g / day) will be assessed by dietary survey on 24-hour recall.	Change from Baseline Fat intake on months 0, 3 at 6 months.
Secondary	Sodium intake	Sodium intake (gm / day) will be evaluated by dietary survey on 24-hour recall.	Change from Baseline Sodium intake on months 0, 3 at 6 months.
Secondary	Water intake	Water intake (ml / day) will be evaluated by dietary survey on 24-hour recall.	Change from Baseline Water intake on months 0, 3 at 6 months.