The Effect of NICE Support Program on Frailty and Quality of Life in Patients With Heart Failure

National Yang Ming Chiao Tung University

Status: Completed

Conditions: Quality of Life; Frailty

Treatments: Behavioral: NICE Support Program

Study type: Interventional

Funder types: Other

Identifiers

NCT05366686

YM108131E

Details and patient eligibility

About

This RCT study aims to examine effects of a NICE Support Program in heart failure patients.

The following hypotheses were tested: patients who received the NICE program will report significant improvement in frailty , social support, anxiety, and depression, quality of life, and nutritional assessment at baseline,4 weeks, 12 weeks and 24 weeks.

Full description

This study aims to develop NICE Support program, and examine the effects of an NICE program in heart failure patients. An experimental design is used. Subjects are selected using a purposeful sampling and are randomly assigned to the intervention or control group by using block size randomization method. Patients in the intervention group will receive a 12 week NICE Support program including: individual consultation, nutritional consultation, teaching exercise which contain walking and resistance exercise by using elastic bands and elastic balls. Data are collected by physical indicators and a structural questionnaire to measure frailty, quality of life, social support, anxiety and depression, symptom distress at baseline, 4 weeks, 12 weeks and 24 weeks . Data analysis includes descriptive statistics, Pearson correlation coefficient, independent t test, chi square, one way ANOVA and generalized estimating equation.

Enrollment: 240 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged above 20 and stable condition and had received physical activity.
2. Clear consciousness, can communicate with Chinese and Taiwanese.
3. Consent to join in this study.
4. Have a smartphone and be able to join social media(Line: heart together-go go go )

Exclusion criteria

1. Bed-ridden or unable to perform activities of daily living independently.
2. Unstable illness condition.
3. Emergency condition.
4. Contraindications of performing exercise such as uncontrolled hypertension, uncontrolled arrhythmia.
5. Patients with increased nerve, muscle, bone or rheumatoid diseases due to exercise

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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240 participants in 2 patient groups

Frailty and Quality of Life in Patients With Heart Failure

Experimental group

Description:

Patients in this group will receive a 12 week exercise program including: (1) one 40-60 minute individual consultation (teaching exercise which contain walking and resistance exercise by using elastic bands and elastic balls); (2) provided exercise booklet, exercise log, exercise video; (3) Nutritional consultation; (4) telephone follow-up once per week for 12 weeks

Treatment:

Behavioral: NICE Support Program

Frailty and Quality of Life

No Intervention group

Description:

Patients in this group maintain their daily life activities, and there is no intervention given.