Frail Elderly SyndromeNCT03797352
HOPE (Healthy Older People Everyday) To Age in Place
A study testing Multicomponent exercise in people with Frail Elderly Syndrome, run by National University Hospital, Singapore.
Trial summary
Certain clinical syndromes eg frailty, sarcopenia, dementia, depression, cognitive impairment, vision impairment, falls in older adults carry an increased risk for poor health outcomes and if identified early, can be prevented, delayed or reversible. Read more about this study
- Who is it for?
- Ages 65 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Frail Elderly Syndrome
- What is being tested?
- Multicomponent exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2019to May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 120 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Pre frail or frail but ambulant (Frail scale score of at least 1)
- Able to walk 400m aided or unaided (at least one bus stop away)
- Has no significant heart or lung problems
- Grip strength not more than 25kg for males and 18kg for females
Who cannot join
- Unable to give consent personally
- Wheelchair bound or at a very high falls risk
- Unable to participate due to underlying health problems including severe weakness due to stroke
- Undergoing active cancer treatment
Trial locations and contacts
No sites are listed yet.
About this study
Official title: HOPE (Healthy Older People Everyday) To Age in Place: Design and Implementation of an Innovative and Cost Effective Electronic Rapid Geriatric Assessment Tool for the Screening and Management of Frailty in Community Dwelling Older Adults
Certain clinical syndromes eg frailty, sarcopenia, dementia, depression, cognitive impairment, vision impairment, falls in older adults carry an increased risk for poor health outcomes and if identified early, can be prevented, delayed or reversible. There is evidence to suggest that exercise and dietary intervention can help delay or prevent sarcopenia, frailty and dementia. Through early screening and detection of frailty and cognitive impairment, the investigators will be able to identify participants at risk of future physical or mental decline in primary care setting and ambulatory care clinics. Those prefrail, frail but ambulant with / without cognitive impairment will be randomised to dual task exercise with/without cognitive stimulation therapy and health education. The main hypothesis is that the combination of multicomponent group exercise activities and dual task exercise is effective in reversing frailty and improving cognition.
Read the detailed description
Major challenges in the Singapore healthcare landscape include a rapidly aging population, due to rising life expectancy at birth combined with declining total fertility, and an epidemiological transition in the main source of disease burden from communicable and infectious conditions to non-communicable, chronic conditions. While acute care will always remain a crucial component of healthcare delivery systems, the increased healthcare burden centered on chronic diseases and the concomitant aging population is putting increased strain on healthcare resources. Frailty is reversible and progression to dementia can be delayed. From most recent study, prevalence of pre-frailty is 37% and mild cognitive impairment about 15-20%. WHO's definition of healthy ageing is maintaining functional ability. Cognicise, a dual task exercise has shown to delay decline in cognition and there are many studies which shows aerobic exercise improves endurance. Patients seen in Geriatric, Medicine Clinic or polyclinics who are prefrail, frail but ambulant with / without cognitive impairment will be randomised to dual task exercise with/without cognitive stimulation therapy and health education. In addition, high protein diet has been shown to improve muscle protein synthesis. Therefore, the aims of the study are to assess: a) Assess the effectiveness of dual task exercise with/without cognitive stimulation therapy b) Effect of health education alone for delaying the progression to dementia and mobility decline c) Assess impact of exercise on inflammatory and bone health biomarkers eg IL, TNF, Osteocalcin, sclerostin and C telopeptide in a subgroup of older adults randomly selected.
- Conditions
- Frail Elderly Syndrome
- Being tested
- Multicomponent exercise
- Keywords
- Bone Health, Cognitive Decline, Health Education, Mobility Decline
- Medical subject headings
- Cognitive Dysfunction, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent exerciseOther
To identify frailty and other potential health issues, and determine if Multicomponent exercise helps at-risk elderly to have better health outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Receive healthy ageing advice every 3 months for the duration of 12 months |
| Intervention | Experimental | To participate in supervised Multicomponent exercise (combined exercise and cognitive activity) up to three times a week for 6 months and receive healthy ageing advice Receives: Other: Multicomponent exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in frailty status
Changes in frailty status by 5-item FRAIL scale Scale range from 0 to 5, the higher the value, the more frail (3 or greater = frailty; 1 or 2 = prefrail)
Measured: 1 year
Functional improvement
Changes in short physical performance battery (SPPB) summary score 3 subscales (range from 0 to 4 for balance, gait speed and chair stand) summed to give total score range from 0 to 12. The higher the value, the better the performance of lower extremity.
Measured: 1 year
Secondary outcomes (6)
Upper extremity strength
Changes in handgrip strength test performance (kg)
Measured: 1 year
Reduction of prevalence of depression
Changes in Geriatric Depression Scale (GDS) Scale range from 0 to 15, the higher the score, the greater the likelihood of depression. A score > 5 points is suggestive of depression, a score ≥ 10 points is almost always indicative of depression
Measured: 1 year
reduction in social isolation
Changes in Lubben Social Network Scale (LSNS-6). Scale range from 0 to 30, the lower the value, the more likelihood of social isolation, A score of 12 and lower delineates "at-risk" for social isolation
Measured: 1 year
Improved quality of life
Changes in EuroQoL-5D (EQ5D) score 5 subscales (1 to 5): Mobility, self-care, usual activities, pain/discomfort, anxiety/depressed Each subscale assessed individually.
Measured: 1 year
Improved cognition
Changes in Montreal Cognitive Assessment (MoCA), the scoring range from 0 to 30, the lower the scoring, the more likelihood of cognitive impairment. A score of 26 and higher is generally considered normal.
Measured: 1 year
Improved cognition
Changes in Mini Mental State Examination (MMSE) score 5 subscales: Orientation (0 to 10), Registration (0 to 3), Attention and Calculation (0 to 5), Recall (0 to 3), Language and Praxis (0 to 9). Total scale range from 0 to 30, the higher the value, the less cognitive impairment. A score of 23 or lower is indicative of cognitive impairment.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2019
- Study startJan 2019 (estimated)
- Primary completionMay 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail Elderly SyndromeStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore
- Responsible party
- Principal investigator, Medicine, National University Hospital, Singapore
- Investigators
- Associate Professor Reshma Merchant, MD, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03797352
- Sponsor's protocol ID
- 2108/11
- Status last verified
- Jan 2019
- First submitted
- 1 Jan 2019
- Last updated
- 9 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HOPE (Healthy Older People Everyday) To Age in Place: Design and Implementation of an Innovative and Cost Effective Electronic Rapid Geriatric Assessment Tool for the Screening and Management of Frailty in Community Dwelling Older Adults
- ClinicalTrials.gov ID
- NCT03797352
- Acronym / sponsor ID
- 2108/11
- Conditions
- Frail Elderly Syndrome
- Keywords
- Bone Health, Cognitive Decline, Health Education, Mobility Decline
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore
- Study start
- Jan 2019 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 9 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Certain clinical syndromes eg frailty, sarcopenia, dementia, depression, cognitive impairment, vision impairment, falls in older adults carry an increased risk for poor health outcomes and if identified early, can be prevented, delayed or reversible. There is evidence to suggest that exercise and dietary intervention can help delay or prevent sarcopenia, frailty and dementia. Through early screening and detection of frailty and cognitive impairment, the investigators will be able to identify participants at risk of future physical or mental decline in primary care setting and ambulatory care clinics. Those prefrail, frail but ambulant with / without cognitive impairment will be randomised to dual task exercise with/without cognitive stimulation therapy and health education. The main hypothesis is that the combination of multicomponent group exercise activities and dual task exercise is effective in reversing frailty and improving cognition.
Detailed description
Major challenges in the Singapore healthcare landscape include a rapidly aging population, due to rising life expectancy at birth combined with declining total fertility, and an epidemiological transition in the main source of disease burden from communicable and infectious conditions to non-communicable, chronic conditions. While acute care will always remain a crucial component of healthcare delivery systems, the increased healthcare burden centered on chronic diseases and the concomitant aging population is putting increased strain on healthcare resources. Frailty is reversible and progression to dementia can be delayed. From most recent study, prevalence of pre-frailty is 37% and mild cognitive impairment about 15-20%. WHO's definition of healthy ageing is maintaining functional ability. Cognicise, a dual task exercise has shown to delay decline in cognition and there are many studies which shows aerobic exercise improves endurance. Patients seen in Geriatric, Medicine Clinic or polyclinics who are prefrail, frail but ambulant with / without cognitive impairment will be randomised to dual task exercise with/without cognitive stimulation therapy and health education. In addition, high protein diet has been shown to improve muscle protein synthesis. Therefore, the aims of the study are to assess: a) Assess the effectiveness of dual task exercise with/without cognitive stimulation therapy b) Effect of health education alone for delaying the progression to dementia and mobility decline c) Assess impact of exercise on inflammatory and bone health biomarkers eg IL, TNF, Osteocalcin, sclerostin and C telopeptide in a subgroup of older adults randomly selected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Receive healthy ageing advice every 3 months for the duration of 12 months |
| Intervention | Experimental | Other: Multicomponent exerciseTo participate in supervised Multicomponent exercise (combined exercise and cognitive activity) up to three times a week for 6 months and receive healthy ageing advice |
Who may qualify
- Ages
- 65 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Pre frail or frail but ambulant (Frail scale score of at least 1)
- Able to walk 400m aided or unaided (at least one bus stop away)
- Has no significant heart or lung problems
- Grip strength not more than 25kg for males and 18kg for females
Key exclusion criteria (4 listed)
- Unable to give consent personally
- Wheelchair bound or at a very high falls risk
- Unable to participate due to underlying health problems including severe weakness due to stroke
- Undergoing active cancer treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multicomponent exerciseTo identify frailty and other potential health issues, and determine if Multicomponent exercise helps at-risk elderly to have better health outcomes. | Other | Intervention |
Primary outcome
Changes in frailty status
Time frame: 1 year
Changes in frailty status by 5-item FRAIL scale Scale range from 0 to 5, the higher the value, the more frail (3 or greater = frailty; 1 or 2 = prefrail)
Functional improvement
Time frame: 1 year
Changes in short physical performance battery (SPPB) summary score 3 subscales (range from 0 to 4 for balance, gait speed and chair stand) summed to give total score range from 0 to 12. The higher the value, the better the performance of lower extremity.
6 secondary outcomes
Upper extremity strength
Time frame: 1 year
Reduction of prevalence of depression
Time frame: 1 year
reduction in social isolation
Time frame: 1 year
Improved quality of life
Time frame: 1 year
Improved cognition
Time frame: 1 year
Improved cognition
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Frail Elderly Syndrome
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Comparıson of the Effıcacy of Conventıonal Exercıse and Pılates ın Pre-fraıl and Fraıl Older Adults
Frailty Syndrome, Prefrail Elderly
Not yet recruiting
Effect of Animation-Based Digital Education on Risk Knowledge and Frailty in Older Adults
Aging, Frail Elderly
Active, not recruiting
Implementing, Evaluating, and Scaling Up of the Strengthening a Palliative Approach in Long Term Care (SPA-LTC) Program
Frail Elderly Syndrome
Recruiting
Feasibility and Effects of Inspiratory Muscle Training Combined With Blood Flow Restriction for Frail Older Adults
Frailty Syndrome, Older Adults
Recruiting
Involvement of Muscle Mitochondrial Dysfunction in Frailty in Older Adults. Role of Exercise
Diabetes Type 2, Frail Elderly Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Associate Professor Reshma Merchant, MD principal investigator
National University Hospital, Singapore
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent exercise in people with Frail Elderly Syndrome, run by National University Hospital, Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Associate Professor Reshma Merchant, MD (67795555, reshmaa@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in frailty status (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2019.