Promoting Health LongevIty Through Mitigation and Prevention of Frailty in Community-dwelling Elderly (Pro-LIFE)

NCT04656938 | Unknown

• 1 other identifier: 2018/2353
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

The current healthcare response to frailty has been mainly reactive to acute health crises of the elderly. With its insidious onset and progression, frailty is often not apparent unless actively sought. Well-validated models of frailty already exist and, instead of trying to create new frailty criteria or insisting on a universal approach to measuring frailty, it is needed to move on to higher levels of care systems supporting their practical implementation, mapping the chosen frailty instrument to its specific role. This pragmatic study will equip older persons with awareness of their frailty status through community-based screening, allowing for timely stage-specific care to avoid deleterious outcomes. While older persons meeting frailty criteria will be referred for comprehensive geriatric assessment, pre-frail older persons will be targeted for multi-factorial exercise and nutritional intervention in the community to reverse the frailty trajectory. An over-arching aim will be to create a sustainable triaging system and early intervention programme that can be administered by trained members of the community. This will allow older persons to receive regular re-assessments in the community such that any transitions to a higher state of frailty may be captured and promptly addressed.

Conditions

Frailty; Frailty Syndrome

Outcome Measures

Primary Outcomes (3)

• Frailty Prevalence in Community-dwelling older adults

  Prevalence of pre-frailty and frailty in community-dwelling older adults aged \>55 years who attend frailty screening. Frailty will be measured using the 5-item FRAIL questionnaire, which assesses for self-reported fatigue, resistance, ambulation, illnesses and loss of weight. 1 point is assigned for each positive response, and participants are categorized as frail (score 3-5), pre-frail (1-2) or robust (0). Agreement of the FRAIL scale with established frailty measures - Fried Phenotype and Frailty Index (35-item) will be examined.

  Baseline

• Proportion of pre-frail participant reverting to robustness following a 4-month multi-factorial physical exercise and nutrition intervention programme

  For intervention eligibility, pre-frailty will be operationalized as: (i) FRAIL score 1-2, or (ii) FRAIL score 0 but with weak grip strength or slow gait speed based on Asian Working Group for Sarcopenia cut-offs. The proportion of pre-frail participants who revert to being robust at the end of the 4-month intervention programme will be measured.

  End of intervention (7-month)

• Change in physical performance measures among pre-frail older adults following a 4-month exercise and nutrition intervention programme

  Physical performance measures include grip strength, gait speed (time taken to 10-m walk at usual pace), lower limb strength (time taken to complete 5 chair stands and number of chair stands completed in 30-seconds), upper and lower limb flexibility (back-scratch test and modified sit-and-reach test), upper limb dexterity (box-and-block test), tandem and dynamic balance (Timed-Up-and-Go test), and cardiorespiratory endurance (6-minute walk test). Cut-off values for tests of gait speed, balance and chair-stand will be applied to derive a score on the Short Physical Performance Battery as a composite measure of physical performance.

  End of intervention (7-month)

Secondary Outcomes (4)

• Performance in physical fitness tests at 3 month (immediate pre-intervention)

  3-month

• Performance in physical fitness tests at 7-month (immediate post-intervention)

  7-month

• Performance in physical fitness tests at 13-month (6 months post-intervention)

  13-month

• Performance in physical fitness tests at 19-month (12 months post-intervention)

  19-month

Interventions

Pre-frail intervention BEHAVIORAL

Pre-frail partiipants will undergo 4 month intervention consisted of group-based physical exercise and nutritional classes.

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• any community-dwelling adult aged 55 and above
• able to ambulate independently (use of walking aids permitted)

You may not qualify if:

• For the pre-frail intervention programme, older adults with significant cognitive impairment, as defined using age- and education-adjusted local norms on the modified Chinese version of the Mini-Mental State Examination (CMMSE) will be excluded

Sponsors & Collaborators

• Sengkang General Hospital: lead

Study Sites (1)

Sengkang General Hospital

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Laura Tay

  Sengkang General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Tay

CONTACT

64722000; laura.tay.b.g@singhealth.com.sg

Ng Yee Sien

CONTACT

64722000; ng.yee.sien@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a pre-post study design with a single group and no control arm. The study aims to screen 700 participants, of which, 220 pre-frail seniors to be recruited into the intervention programme.

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: December 7, 2020
• Study Start: May 1, 2018
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: December 7, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)