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

U

University of Putra Malaysia (UPM)

Status

Completed

Conditions

Frail Elderly Syndrome

Treatments

Behavioral: Frailty Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT04327544
GP-IPS/2017/9547700

Details and patient eligibility

About

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.

Enrollment

59 patients

Sex

All

Ages

60+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Man or women aged 60 years and above
  • Meet one or two frailty phenotype score (pre-frail)
  • Able to ambulate without personal assistance
  • Residing in the PPR flats in Kuala Lumpur
  • Willing to participate in the intervention program with informed consent

Exclusion criteria

  • Self-reported chronic diseases (heart-related disease, COPD, stroke, cancer, asthma, renal dysfunction, terminally ill)
  • PAR-Q & YOU questionnaire (Yes≥1)
  • Bedridden
  • Cognitive impairment (ECAQ<6)
  • Sensory impairment (visual & hearing) that will interfere with communication
  • Unable to read and write
  • Already involved or still participating in any health interventional studies
  • Any sustained fracture (hip, vertebrata) in past six month
  • Any surgery (hip, abdominal area) in past six months

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

59 participants in 2 patient groups

Frailty Intervention group
Experimental group
Description:
A multi-domain intervention program that includes nutrition education and low to moderate multi-component exercise intervention.
Treatment:
Behavioral: Frailty Intervention
Control group
No Intervention group
Description:
Respondents in the control group will not receive any nutritional education or exercise intervention activities.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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