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Tackling Disruptions to Frailty Interventions: Developing Personalized Interventions Targeted for Older Persons With Cardiac Frailty (INDEPENDENCY)

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ClinicalTrials.gov Identifier: NCT05946174
Recruitment Status : Recruiting
First Posted : July 14, 2023
Last Update Posted : August 8, 2023
Sponsor:
Information provided by (Responsible Party):
National Heart Centre Singapore

Study Description
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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.


Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Other: Intervention Set A Other: Intervention Set B Other: Intervention Set C Not Applicable

Detailed Description:

BACKGROUND Cardiovascular disease is a formidable disruptor of interventions related to exercise intervention. Patients and physicians face uncertainty about dispensing safe and effective exercise programs to frail patients with concomitant cardiovascular disease. This hesitancy permeates across transitions from acute to step-down care to community settings. Uncertainties include fear of exacerbating heart conditions, individual variability in exercise response and what exercise targets to reach that is rational for each patient. Often, little or no exercise intervention is applied in the acute to step-down phases, which are the periods most critical for frailty reversal. Current dietary interventions do not address the special nutritional needs of acute cardiovascular conditions like heart failure, and may paradoxically induce a syndrome of cardiac cachexia that contributes to the downward spiral of frailty.

STUDY DESIGN:

This will be a prospective randomized clinical trial.

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. At enrolment, pre-defined study time points and end of study, participants will undergo assessments of clinical status, frailty status, cardiovascular function, nutrition, quality of life (QOL), diet/exercise behaviour, and biospecimen sampling. Three Intervention Sets 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. During the trial, exercise intervention is performed in hospitals and community hospitals by physiotherapists. Associated factors such as dietary, comorbidities and other related habits will be tracked simultaneously during the trial

Intervention Set A: exercise sessions and meals over approximately 12 weeks. Intervention Set B : exercise sessions and meals over approximately 3 weeks. Intervention Set C: meals over approximately 3 weeks.

PROCEDURES

  1. Baseline Procedures i. Cardiovascular measurements

    • Non-invasive brachial blood pressure machine
    • Echocardiography
    • Electrocardiography ii. Biospecimen collection iii. Six-minute walk test iv. Musculoskeletal Analysis v. Cardiopulmonary exercise test (CPET)/ Treadmill vi. Questionnaires vii. Timed up and go (TUG) test

  2. Post-intervention procedures i. Cardiovascular measurements

    • Non-invasive brachial blood pressure machine
    • Echocardiography
    • Electrocardiography ii. Biospecimen collection iii. Six-minute walk test iv. Musculoskeletal Analysis v. Questionnaires vi. Timed up and go (TUG) test
  3. Closing questionnaires
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tackling Disruptions to Frailty Interventions: Developing Personalized Interventions Targeted for Older Persons With Cardiac Frailty
Actual Study Start Date : July 12, 2023
Estimated Primary Completion Date : June 21, 2028
Estimated Study Completion Date : June 21, 2028
Arms and Interventions
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Arm Intervention/treatment
Experimental: Outpatient clinic/community participants receiving exercise sessions and meals (A1)
Outpatient clinic/community participants receiving intervention Set A (exercise sessions and meals over approximately 12 weeks)
 Other: Intervention Set A
exercise sessions and meals over approximately 12 weeks
No Intervention: Outpatient clinic/community participants receiving control/usual care (A2)
Outpatient clinic/community participants receiving control/usual care
Experimental: Step-down community hospital participants receiving exercise sessions and meals (B1)
Step-down community hospital participants receiving Intervention Set B (exercise sessions and meals over approximately 3 weeks)
 Other: Intervention Set B
exercise sessions and meals over approximately 3 weeks
No Intervention: Step-down community hospital participants receiving control/usual care (B2)
Step-down community hospital participants receiving control/usual care
Experimental: Acute hospital participants receiving meals (C1)
Acute hospital participants receiving Intervention Set C (meals over approximately 3 weeks)
 Other: Intervention Set C
meals over approximately 3 weeks
No Intervention: Acute hospital participants receiving control/usual care (C2)
Acute hospital participants receiving control/usual care


Outcome Measures
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Primary Outcome Measures :
  1. Improvement in cardiovascular markers [ Time Frame: at 14 weeks from baseline ]
    • Change in cardiovascular variables are diastolic function variables such as mitral annular velocities (m/s) OR;
    • Change in Aerobic capacity (V02, ml/kg/min)

  2. Improvement in skeletal muscle [ Time Frame: at 14 weeks from baseline ]
    Change in skeletal muscle mass (grams)

  3. Improvement in Fried Frailty Phenotype Score (improvement in any domain) (i.e., reduction in score) [ Time Frame: at six months from baseline ]

Secondary Outcome Measures :
  1. Improvement in metabolite level [ Time Frame: Three months and six months from baseline ]
    Any change in metabolite (microM)

  2. Improvement in Quality of life (QOL): EuroQOL-5D-5L (higher score) [ Time Frame: Three months and six months from baseline ]
    A unit increase (i.e., improvement) in QOL score


Other Outcome Measures:
  1. Proportion of participants who experience a major adverse cardiovascular events [ Time Frame: Thirty-six (36) months from baseline ]
    Include cardiac mortality, acute myocardial infarction, unstable angina, any revascularization, heart failure, atrial fibrillation, strokes

  2. Other events include proportion of participants who experience : death, falls, fractures, hospitalization for any cause, admission into nursing home [ Time Frame: Thirty-six (36) months from baseline ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 21 years old
  • Outdoor ambulant

Exclusion Criteria:

  1. Bed-bound
  2. Dementia (Stage 6 onwards)
  3. Residing in sheltered or nursing home
  4. Cancer (to avoid confounding with cardiac disease sequelae from cancer)
  5. Participation in ongoing clinical trials that involve interventional drugs or devices
  6. Uncontrolled hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥90mmHg) despite being on treatment for hypertension
  7. Low blood pressure (systolic blood pressure <90mmHg or diastolic blood pressure <40mmHg)
  8. Uncontrolled atrial fibrillation (controlled atrial fibrillation is allowed)
  9. Ventricular arrhythmias (such as ventricular tachycardia)
  10. Renal failure on dialysis
  11. Chronic kidney disease Stage 4 and above
  12. Nephrotic syndrome
  13. Liver cirrhosis Child's B and above
  14. Inflammatory Bowel Disease
  15. Severe uncontrolled gout
  16. Poorly controlled Diabetes Hba1c ≥9%
  17. On warfarin
  18. Presence of food allergies (such as shell-fish, prawn)
  19. Patient's life expectancy is expected to be less than one year at the time of potential enrolment as assessed by the investigator
  20. Nasogastric or parenteral nutrition
  21. Hypertrophic cardiomyopathy
  22. Cardiac amyloidosis
  23. Cardiac sarcoidosis
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05946174


Contacts
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Contact: Angela Su-Mei Koh +65 6704 8961 angela.koh.s.m@singhealth.com.sg
Contact: Gina Sihui Lee +65 6704 2228 gina.lee.s.h@nhcs.com.sg

Locations
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Singapore
Alexandra Hospital Recruiting
Singapore, Singapore, 159964
Contact: Laureen Yi-Ting Wang         
National Heart Centre Singapore Recruiting
Singapore, Singapore, 169609
Contact: Angela Su-Mei Koh, MBBS, MPH    +65 6704 8961    angela.koh.s.m@singhealth.com.sg   
Contact: Gina Sihui Lee    +65 6704 2228    gina.lee.s.h@nhcs.com.sg   
Changi General Hospital Recruiting
Singapore, Singapore, 529889
Contact: Chun How Ooi         
Sengkang General Hospital Recruiting
Singapore, Singapore, 544886
Contact: Zijuan Huang         
Jurong Community Hospital Recruiting
Singapore, Singapore, 609606
Contact: Alvin Ong         
NHG Polyclinics Recruiting
Singapore, Singapore
Contact: Shu Yun Tan         
Sponsors and Collaborators
National Heart Centre Singapore
Investigators
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Principal Investigator: Angela Su-Mei Koh, MBBS, MPH National Heart Centre Singapore
More Information
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Publications:

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Responsible Party: National Heart Centre Singapore
ClinicalTrials.gov Identifier: NCT05946174    
Other Study ID Numbers: 2023/2086
First Posted: July 14, 2023    Key Record Dates
Last Update Posted: August 8, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Heart Centre Singapore:
Frailty
Intervention
Cardiac Frailty Interventions
Additional relevant MeSH terms:
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Cardiovascular Diseases
Frailty
Pathologic Processes