NCT04327544: FINE

A Health Promotion Program to Prevent Frailty and Improve Frailty Status Among Pre-frail Elderly: Frailty Intervention Through Nutrition Education and Exercises.

Completed NA Last updated 15 May 2023

What this trial tests

NA trial testing Frailty Intervention in Frail Elderly Syndrome in 59 participants. Completed in 9 December 2022.

Timeline

14 June 2022

Primary endpoint
9 December 2022

9 December 2022

Quick facts

Lead sponsor	Universiti Putra Malaysia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	59
Start date	14 June 2022
Primary completion	9 December 2022
Estimated completion	9 December 2022
Sites	1 location across Malaysia

Drugs / interventions tested

• Frailty Intervention

Conditions studied

• Frail Elderly Syndrome — all drugs for Frail Elderly Syndrome →

Sponsor

Universiti Putra Malaysia — full company profile →

Who can join

60 and older, any sex, with Frail Elderly Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Prevention of frailty is a major concern in geriatrics due to its high prevalence and various adverse health outcomes among elderly population. This two phases of study aims to develop, implement and evaluate the effectiveness of nutritional education and exercise intervention among pre-frail Malaysian elderly. In the first phase of the study, the frailty intervention module and educational materials (flipchart, PowerPoint slides, booklet and posters) for the frailty intervention program will be developed based on extensive literature review and discussions with research group (dietitians, nutritionists, physiotherapists and medical doctor). The module will be developed to provide knowledge and skills to health practitioners in order to conduct the program towards pre-frail elderly, while the educational materials will aid health practitioners and the elderlies in teaching and learning process respectively. Evaluation for acceptability of frailty intervention module and educational materials will also be conducted in phase 1 study. The second phase of the study will be a three- month (12 weeks), single-blind, two-armed, cluster randomised controlled trial (cluster RCT) research to evaluate the effects of combined nutritional education and exercise intervention among pre-frail elderly in PPR flats Kuala Lumpur. Screening of the pre-frail status among the elderly in PPR flats Kuala Lumpur will be conducted in order to recruit subjects who match the inclusion criteria to join the intervention program. Evaluation will be performed during pre-intervention (1 week before intervention starts), post-intervention (3 month immediate after intervention starts) and 3-month follow-up (3 months after post-intervention). The frailty intervention includes both nutritional education and low-intensity exercise intervention. Generally, respondents in the intervention group will received the developed educational materials and participate in healthy eating talk, group diet counselling, multicomponent exercise sessions. In short, the interventions being examined will provide major potential benefits to the older population in terms of preventing transition to frailty and potentially reduce adverse health outcomes.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Frailty Intervention through Nutrition Education and Exercise (FINE). A Health Promotion Intervention to Prevent Frailty and Improve Frailty Status among Pre-Frail Elderly-A Study Protocol of a Cluster Randomized Controlled Trial.
   Mohd Suffian NI, Adznam SN', Abu Saad H, Chan YM, et al · · 2020 · cited 18× · PMID 32927741 · DOI 10.3390/nu12092758