HOPE (Healthy Older People Everyday) To Age in Place

Frail Elderly Syndrome Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03797352
• Other study ID #: 2108/11
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2019
• Est. completion date: May 2021

Study information

• Verified date: January 2019
• Source: National University Hospital, Singapore
• Contact: Associate Professor Reshma Merchant, MD
• Phone: 67795555
• Email: reshmaa[@]nuhs.edu.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: May 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Frail Elderly Syndrome

Intervention

Other:
• Multicomponent exercise
To identify frailty and other potential health issues, and determine if Multicomponent exercise helps at-risk elderly to have better health outcomes.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
National University Hospital, Singapore	National Medical Research Council (NMRC), Singapore

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	1 year
Primary	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.	1 year
Secondary	Upper extremity strength	Changes in handgrip strength test performance (kg)	1 year
Secondary	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	1 year
Secondary	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	1 year
Secondary	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.	1 year
Secondary	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.	1 year
Secondary	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.	1 year