NCT05366686

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 18, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 9, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2024

Completed
Last Updated

July 10, 2025

Status Verified

May 1, 2024

Enrollment Period

2.1 years

First QC Date

May 4, 2022

Last Update Submit

July 5, 2025

Conditions

FrailtyQuality of Life

Keywords

FrailtyQuality of LifeHeart failureExercise programnutrition

Outcome Measures

Primary Outcomes (2)

  • Change Frailty Assessment Scale for Heart Failure, FAS-HF) and Clinical Frailty Scale scores

    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

    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 Outcomes (2)

  • The Minnesota living with heart failure questionnaire(MLHFQ)

    baseline, 4week, 12 week, 24week

  • Changes in anxiety and depression scores

    baseline, 4week, 12 week, 24week

Study Arms (2)

Frailty and Quality of Life in Patients With Heart Failure

EXPERIMENTAL

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

Frailty and Quality of Life

NO INTERVENTION

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

Interventions

NICE Support ProgramBEHAVIORAL

Patients in experimental group will receive a 12 week NICE Support program; patients in control group maintain their usual life activities.

Frailty and Quality of Life in Patients With Heart Failure

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Yang-Ming University

Taipei, 112, Taiwan

Location

Related Publications (2)

  • 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

    BACKGROUND

  • Wang TC, Hsieh YC, Yang CY, Lee CM, Liu CY, Chiou AF. Effects of a multimodal support intervention (the NICE-Support programme) on frailty and quality of life in patients with heart failure: a randomized controlled trial. Eur J Cardiovasc Nurs. 2026 Jan 3:zvaf187. doi: 10.1093/eurjcn/zvaf187. Online ahead of print.

    PMID: 41482005DERIVED

MeSH Terms

Conditions

FrailtyHeart Failure

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular Diseases

Study Officials

  • Ai-Fu Chiou, PhD

    National Yang Ming Chiao Tung University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
One research assistant is trained for being a outcomes assessor in this study who did not know the allocation of participants.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 4, 2022

First Posted

May 9, 2022

Study Start

January 18, 2022

Primary Completion

February 8, 2024

Study Completion

February 8, 2024

Last Updated

July 10, 2025

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)