Clinical trial NCT05366686: The Effect of NICE Support Program on Frailty and Quality of Life in Patients With Heart Failure
Official title: The Effect of NICE Support Program on Frailty and Quality of Life in Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Quality of Life
Keywords: Frailty
Quality of Life
Heart failure
Exercise program
nutrition
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2022-05-09
Enrollment: 240
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients in the intervention group will receive a 12 week exercise program including: individual consultation, nutrition consultation, teaching exercise which contain walking and resistance exercise by using elastic bands and elastic balls.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change Frailty Assessment Scale for Heart Failure, FAS-HF) and Clinical Frailty Scale scores
timeFrame: baseline, 4week, 12 week, 24week
measure: Changes in symptoms distress scores
timeFrame: baseline, 4week, 12 week, 24week
Secondary outcomes:
measure: The Minnesota living with heart failure questionnaire(MLHFQ)
timeFrame: baseline, 4week, 12 week, 24week
measure: Changes in anxiety and depression scores
timeFrame: baseline, 4week, 12 week, 24week
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Yang-Ming University
Study officials:
affiliation: National Yang Ming Chiao Tung University
name: Ai-Fu Chiou, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Afilalo, J. (2019). Evaluating and treating frailty in cardiac rehabilitation. Clinics in Geriatric Medicine, 35(4), 445-457. https://doi.org/10.1016/j.cger.2019.07.002. PMID: 31543177 Afilalo J, Alexander KP, Mack MJ, Maurer MS, Green P, Allen LA, Popma JJ, Ferrucci L, Forman DE. (2014). Frailty assessment in the cardiovascular care of older adults. Journal of the American College of Cardiology, 63(8), 747-762. https://doi.org/10.1016/j.jacc.2013.09.070. PMID: 24291279 Denfeld QE, Winters-Stone K, Mudd JO, Gelow JM, Kurdi S, Lee CS. (2017). The prevalence of frailty in heart failure: A systematic review and meta-analysis. The International Journal of Cardiology, 236, 283-289. PMID: 28215466 Flint KM, Pastva AM, Reeves GR. (2019). Cardiac rehabilitation in older adults with heart failure: Fitting a square peg in a round hole. Clinics in Geriatric Medicine, 35(4), 517-526. https://doi.org/10.1016/j.cger.2019.07.008. PMID: 31543182