- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03797352
HOPE (Healthy Older People Everyday) To Age in Place
January 6, 2019 updated by: Medicine, National University Hospital, Singapore
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
1000
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Associate Professor Reshma Merchant, MD
- Phone Number: 67795555
- Email: reshmaa@nuhs.edu.sg
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 120 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Receive healthy ageing advice every 3 months for the duration of 12 months
|
|
Experimental: Intervention
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
|
To identify frailty and other potential health issues, and determine if Multicomponent exercise helps at-risk elderly to have better health outcomes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
1 year
|
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.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Upper extremity strength
Time Frame: 1 year
|
Changes in handgrip strength test performance (kg)
|
1 year
|
Reduction of prevalence of depression
Time Frame: 1 year
|
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
|
1 year
|
reduction in social isolation
Time Frame: 1 year
|
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
|
1 year
|
Improved quality of life
Time Frame: 1 year
|
Changes in EuroQoL-5D (EQ5D) score 5 subscales (1 to 5): Mobility, self-care, usual activities, pain/discomfort, anxiety/depressed Each subscale assessed individually.
|
1 year
|
Improved cognition
Time Frame: 1 year
|
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.
|
1 year
|
Improved cognition
Time Frame: 1 year
|
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.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Associate Professor Reshma Merchant, MD, National University Hospital, Singapore
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
January 1, 2019
Primary Completion (Anticipated)
May 1, 2021
Study Completion (Anticipated)
May 1, 2021
Study Registration Dates
First Submitted
January 1, 2019
First Submitted That Met QC Criteria
January 6, 2019
First Posted (Actual)
January 9, 2019
Study Record Updates
Last Update Posted (Actual)
January 9, 2019
Last Update Submitted That Met QC Criteria
January 6, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 2108/11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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