NCT05946174

Brief Summary

Background: Muscle mass loss and metabolic dysfunction, exacerbated by inactivity and nutritional inadequacies, underpin both cardiovascular disease and frailty in ageing. The investigators' proposal seeks to develop interventions in exercise and diet that are targeted for older adults with cardiac frailty. Methods: The investigators' proposal is a five-year study comprising of first phase (first 2-2.5 years) and second phase (next 2-2.5 years). In the first phase cardiac frail participants (up to N=500) from each healthcare transition (inpatient hospital, step-down community hospital, outpatient clinic/community) will be randomized to receive Intervention Sets or usual care. The second phase will scale up these programs. Three Intervention Sets A, B, and C will be implemented in the outpatient, step-down community hospital, and acute hospital settings. Diet intervention comprises meal sets prepared with nutrients involved in energy metabolism. Exercise training is facilitated by hospital gyms and hospital physiotherapists. Diet and exercise behavior will be monitored using questionnaires, video conferencing and meal photos. Significance: Clinical studies are urgently needed using consistent frailty tools to evaluate the efficacy and promise of frailty interventions, targeted to achieve reversal/retardation of frailty. When scaled up, these approaches will provide high-quality science needed to manage cardiac frailty towards healthier population ageing.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for not_applicable cardiovascular-diseases

Timeline
25mo left

Started Jul 2023

Longer than P75 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

6 active sites

Status
recruiting

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 Progress58%
Jul 2023Jun 2028

First Submitted

Initial submission to the registry

June 15, 2023

Completed
27 days until next milestone

Study Start

First participant enrolled

July 12, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 14, 2023

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2028

Last Updated

June 5, 2025

Status Verified

April 1, 2025

Enrollment Period

4.9 years

First QC Date

June 15, 2023

Last Update Submit

June 3, 2025

Conditions

Cardiovascular Diseases

Keywords

FrailtyInterventionCardiac Frailty Interventions

Outcome Measures

Primary Outcomes (3)

  • Improvement in cardiovascular markers

    * Change in cardiovascular variables are diastolic function variables such as mitral annular velocities (m/s) OR; * Change in Aerobic capacity (V02, ml/kg/min)

    at 14 weeks from baseline

  • Improvement in skeletal muscle

    Change in skeletal muscle mass (grams)

    at 14 weeks from baseline

  • Improvement in Fried Frailty Phenotype Score (improvement in any domain) (i.e., reduction in score)

    at six months from baseline

Secondary Outcomes (2)

  • Improvement in metabolite level

    Three months and six months from baseline

  • Improvement in Quality of life (QOL): EuroQOL-5D-5L (higher score)

    Three months and six months from baseline

Other Outcomes (2)

  • Proportion of participants who experience a major adverse cardiovascular events

    Thirty-six (36) months from baseline

  • Other events include proportion of participants who experience : death, falls, fractures, hospitalization for any cause, admission into nursing home

    Thirty-six (36) months from baseline

Study Arms (6)

Outpatient clinic/community participants receiving exercise sessions and meals (A1)

EXPERIMENTAL

Outpatient clinic/community participants receiving intervention Set A (exercise sessions and meals over approximately 12 weeks)

Other: Intervention Set A

Outpatient clinic/community participants receiving control/usual care (A2)

NO INTERVENTION

Outpatient clinic/community participants receiving control/usual care

Step-down community hospital participants receiving exercise sessions and meals (B1)

EXPERIMENTAL

Step-down community hospital participants receiving Intervention Set B (exercise sessions and meals over approximately 3 weeks)

Other: Intervention Set B

Step-down community hospital participants receiving control/usual care (B2)

NO INTERVENTION

Step-down community hospital participants receiving control/usual care

Acute hospital participants receiving meals (C1)

EXPERIMENTAL

Acute hospital participants receiving Intervention Set C (meals over approximately 3 weeks)

Other: Intervention Set C

Acute hospital participants receiving control/usual care (C2)

NO INTERVENTION

Acute hospital participants receiving control/usual care

Interventions

Intervention Set AOTHER

exercise sessions and meals over approximately 12 weeks

Outpatient clinic/community participants receiving exercise sessions and meals (A1)
Intervention Set BOTHER

exercise sessions and meals over approximately 3 weeks

Step-down community hospital participants receiving exercise sessions and meals (B1)
Intervention Set COTHER

meals over approximately 3 weeks

Acute hospital participants receiving meals (C1)

Eligibility Criteria

Age21 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 21 years old
  • Outdoor ambulant

You may not qualify if:

  • Bed-bound
  • Dementia (Stage 6 onwards)
  • Residing in sheltered or nursing home
  • Cancer (to avoid confounding with cardiac disease sequelae from cancer)
  • Participation in ongoing clinical trials that involve interventional drugs or devices
  • Uncontrolled hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥90mmHg) despite being on treatment for hypertension
  • Low blood pressure (systolic blood pressure \<90mmHg or diastolic blood pressure \<40mmHg)
  • Uncontrolled atrial fibrillation (controlled atrial fibrillation is allowed)
  • Ventricular arrhythmias (such as ventricular tachycardia)
  • Renal failure on dialysis
  • Chronic kidney disease Stage 4 and above
  • Nephrotic syndrome
  • Liver cirrhosis Child's B and above
  • Inflammatory Bowel Disease
  • Severe uncontrolled gout
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Alexandra Hospital

Singapore, 159964, Singapore

RECRUITING

National Heart Centre Singapore

Singapore, 169609, Singapore

RECRUITING

Changi General Hospital

Singapore, 529889, Singapore

RECRUITING

Sengkang General Hospital

Singapore, 544886, Singapore

RECRUITING

Jurong Community Hospital

Singapore, 609606, Singapore

RECRUITING

NHG Polyclinics

Singapore, Singapore

RECRUITING

Related Publications (4)

  • Koh AS, Gao F, Leng S, Kovalik JP, Zhao X, Tan RS, Fridianto KT, Ching J, Chua SJ, Yuan JM, Koh WP, Zhong L. Dissecting Clinical and Metabolomics Associations of Left Atrial Phasic Function by Cardiac Magnetic Resonance Feature Tracking. Sci Rep. 2018 May 25;8(1):8138. doi: 10.1038/s41598-018-26456-8.

    PMID: 29802321BACKGROUND

  • Koh AS, Gao F, Liu J, Fridianto KT, Ching J, Tan RS, Wong JI, Chua SJ, Leng S, Zhong L, Keng BM, Huang FQ, Yuan JM, Koh WP, Kovalik JP. Metabolomic profile of arterial stiffness in aged adults. Diab Vasc Dis Res. 2018 Jan;15(1):74-80. doi: 10.1177/1479164117733627. Epub 2017 Oct 4.

    PMID: 28976207BACKGROUND

  • Keng BMH, Gao F, Teo LLY, Lim WS, Tan RS, Ruan W, Ewe SH, Koh WP, Koh AS. Associations between Skeletal Muscle and Myocardium in Aging: A Syndrome of "Cardio-Sarcopenia"? J Am Geriatr Soc. 2019 Dec;67(12):2568-2573. doi: 10.1111/jgs.16132. Epub 2019 Aug 16.

    PMID: 31418823BACKGROUND

  • Koh AS, Gao F, Tan RS, Zhong L, Leng S, Zhao X, Fridianto KT, Ching J, Lee SY, Keng BMH, Yeo TJ, Tan SY, Tan HC, Lim CT, Koh WP, Kovalik JP. Metabolomic correlates of aerobic capacity among elderly adults. Clin Cardiol. 2018 Oct;41(10):1300-1307. doi: 10.1002/clc.23016.

    PMID: 30350416BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesFrailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Angela Su-Mei Koh, MBBS, MPH

    National Heart Centre Singapore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Angela Su-Mei Koh

CONTACT

+65 6704 8961angela.koh.s.m@singhealth.com.sg

Gina Sihui Lee

CONTACT

+65 6704 2228gina.lee.s.h@nhcs.com.sg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Set A comprises of outpatient clinic/ community participants, who will be randomized in a 1:1 ratio into Group A1 (receiving Intervention Set A- exercise sessions and meals over approximately 12 weeks) or Group A2 (control/ usual care) Set B comprises of step-down community hospital participants, who will be randomized in a 1:1 ratio into Group B1 (receiving Intervention Set B- exercise sessions and meals over approximately 3 weeks) or Group B2 (control/ usual care) Set C comprises of acute community hospital participants, who will be randomized in a 1:1 ratio into Group C1 (receiving Intervention Set C- meals over approximately 3 weeks) or Group C2 (control/ usual care)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2023

First Posted

July 14, 2023

Study Start

July 12, 2023

Primary Completion (Estimated)

June 21, 2028

Study Completion (Estimated)

June 21, 2028

Last Updated

June 5, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

SG(6)