NCT03797352

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 1, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 9, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

January 9, 2019

Status Verified

January 1, 2019

Enrollment Period

2.3 years

First QC Date

January 1, 2019

Last Update Submit

January 6, 2019

Conditions

Frail Elderly Syndrome

Keywords

Bone HealthCognitive DeclineHealth EducationMobility Decline

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (6)

  • Upper extremity strength

    1 year

  • Reduction of prevalence of depression

    1 year

  • reduction in social isolation

    1 year

  • Improved quality of life

    1 year

  • Improved cognition

    1 year

  • +1 more secondary outcomes

Study Arms (2)

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

Other: Multicomponent exercise

Interventions

Multicomponent exerciseOTHER

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

Intervention

Eligibility Criteria

Age65 Years - 120 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cognitive DysfunctionHealth Education

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Associate Professor Reshma Merchant, MD

    National University Hospital, Singapore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Associate Professor Reshma Merchant, MD

CONTACT

67795555reshmaa@nuhs.edu.sg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head & Senior Consultant, Division of Geriatric Medicine

Study Record Dates

First Submitted

January 1, 2019

First Posted

January 9, 2019

Study Start

January 1, 2019

Primary Completion

May 1, 2021

Study Completion

May 1, 2021

Last Updated

January 9, 2019

Record last verified: 2019-01