Ignite Creation Date:
2024-05-06 @ 7:15 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05946174
Status:
RECRUITING
Last Update Posted:
2023-08-08
First Post:
2023-06-15
Brief Title:
Tackling Disruptions to Frailty Interventions Developing Personalized Interventions Targeted for Older Persons With Cardiac Frailty
Sponsor:
National Heart Centre Singapore
Organization:
National Heart Centre Singapore
Study Overview
Official Title:
Tackling Disruptions to Frailty Interventions Developing Personalized Interventions Targeted for Older Persons With Cardiac Frailty
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INDEPENDENCY
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 2-25 years and second phase next 2-25 years In the first phase cardiac frail participants up to N500 from each healthcare transition inpatient hospital step-down community hospital outpatient cliniccommunity 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 reversalretardation of frailty When scaled up these approaches will provide high-quality science needed to manage cardiac frailty towards healthier population ageing
Methods
The investigators proposal is a five-year study comprising of first phase first 2-25 years and second phase next 2-25 years In the first phase cardiac frail participants up to N500 from each healthcare transition inpatient hospital step-down community hospital outpatient cliniccommunity 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 reversalretardation of frailty When scaled up these approaches will provide high-quality science needed to manage cardiac frailty towards healthier population ageing
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 2-25 years and second phase next 2-25 years In the first phase cardiac frail participants up to N500 from each healthcare transition inpatient hospital step-down community hospital outpatient cliniccommunity 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 dietexercise 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
This will be a prospective randomized clinical trial
The investigators proposal is a five-year study comprising of first phase first 2-25 years and second phase next 2-25 years In the first phase cardiac frail participants up to N500 from each healthcare transition inpatient hospital step-down community hospital outpatient cliniccommunity 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 dietexercise 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None