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

July 5, 2025 updated by: Ai-Fu Chiou

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 112
        • National Yang-Ming University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Frailty and Quality of Life in Patients With Heart Failure
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
Behavioral: NICE Support Program
Patients in experimental group will receive a 12 week NICE Support program; patients in control group maintain their usual life activities.
No Intervention: Frailty and Quality of Life
Patients in this group maintain their daily life activities, and there is no intervention given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change Frailty Assessment Scale for Heart Failure, FAS-HF) and Clinical Frailty Scale scores
Time Frame: baseline, 4week, 12 week, 24week

Changes from baseline Frailty Assessment Scale for Heart Failure, FAS-HF) scores including three indicators: physical, Psychological and social , at 6 weeks, 12 weeks, 24 weeks. FAS-HF scale contains 15 items, each item use Likert scale five point scoring, the total scores ranged from 0 to 45, the higher scores indicate higher frailty.

Changes from baseline Clinical Frailty Scale including nine indicators, the higher scores indicate higher frailty.
baseline, 4week, 12 week, 24week
Changes in symptoms distress scores
Time Frame: baseline, 4week, 12 week, 24week
Changes from baseline symptoms distress scale at 4 weeks, 12 weeks, 24 weeks. Symptoms distress scale contains 17 common symptoms items, each item use Likert scale five point scoring, the total scores ranged from 17 to 85, the higher scores indicate worse symptom distress.
baseline, 4week, 12 week, 24week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Minnesota living with heart failure questionnaire(MLHFQ)
Time Frame: baseline, 4week, 12 week, 24week
Changes from baseline Minnesota living with heart failure questionnaire at 4 weeks, 12 weeks, 24 weeks. The Minnesota living with heart failure questionnaire contains 21 questions regarding the effects of heart failure on patients' physical (eight questions),emotional (five questions) and general (eight questions) dimensions. The possible answer for each question ranges from 0(no) to 5(a lot), and the total score range is 0-105; a higher score indicates lower quality of life .
baseline, 4week, 12 week, 24week
Changes in anxiety and depression scores
Time Frame: baseline, 4week, 12 week, 24week
Changes from baseline hospital anxiety and depression scale at 6 weeks, 12 weeks, 24 weeks. The hospital anxiety and depression scale contains 14 questions(7 for assess anxiety and 7 for assess depression), each item use Likert scale four point scoring, the total scores ranged from 0 to 21, the higher scores indicate more severe anxiety and depression level.
baseline, 4week, 12 week, 24week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ai-Fu Chiou

Investigators

  • Principal Investigator: Ai-Fu Chiou, PhD, National Yang Ming Chiao Tung University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2022

Primary Completion (Actual)

February 8, 2024

Study Completion (Actual)

February 8, 2024

Study Registration Dates

First Submitted

May 4, 2022

First Submitted That Met QC Criteria

May 4, 2022

First Posted (Actual)

May 9, 2022

Study Record Updates

Last Update Posted (Actual)

July 10, 2025

Last Update Submitted That Met QC Criteria

July 5, 2025

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YM108131E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe