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

NCT04327544 | Completed

• 1 other identifier: GP-IPS/2017/9547700
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Frail Elderly Syndrome

Outcome Measures

Primary Outcomes (2)

• Changes in Frailty score

  Frailty score will be assessed using the well-established Malay language standardized phenotype of frailty questionnaire as proposed by Fried et al. The questionnaire evaluates five components of the frailty syndrome (weight loss, exhaustion, weakness, slowness and low activity) and allocates one point for each criterion met. The highest the score indicate worst condition of the elderly in term of frailty.

  The measurement will be conducted three times; pre- intervention (1 week before intervention start), post - intervention (immediately after intervention end) and at 3 months follow - up (3 months after post intervention).

• Changes of Frailty status

  Frailty status will be assessed using the well-established Malay language standardised phenotype of frailty questionnaire as proposed by Fried et al. The questionnaire evaluates five components of the frailty syndrome (weight loss, exhaustion, weakness, slowness and low activity) and allocates one point for each criterion met; respondents meeting zero criteria are defined as non-frail (normal), whereas those meeting one or two criteria are defined as pre-frail, and those meeting three, four or five criteria are defined as frail

  The measurement will be conducted three times; pre- intervention (1 week before intervention start), post - intervention (immediately after intervention end) and at 3 months follow - up (3 months after post intervention).

Secondary Outcomes (10)

• Changes in knowledge, attitude and practice (KAP) towards frailty, nutrition and exercise

  The measurement will be conducted three times; pre- intervention (1 week before intervention start), post - intervention (immediately after intervention end) and at 3 months follow - up (3 months after post intervention).

• Changes in dietary intake

  The measurement will be conducted three times; pre- intervention (1 week before intervention start), post - intervention (immediately after intervention end) and at 3 months follow - up (3 months after post intervention).

• Changes in cognitive status

  The measurement will be conducted three times; pre- intervention (1 week before intervention start), post - intervention (immediately after intervention end) and at 3 months follow - up (3 months after post intervention).

• Changes in functional ability

  The measurement will be conducted three times; pre- intervention (1 week before intervention start), post - intervention (immediately after intervention end) and at 3 months follow - up (3 months after post intervention).

• Changes in mobility status

  The measurement will be conducted three times; pre- intervention (1 week before intervention start), post - intervention (immediately after intervention end) and at 3 months follow - up (3 months after post intervention).

Study Arms (2)

Frailty Intervention group

EXPERIMENTAL

A multi-domain intervention program that includes nutrition education and low to moderate multi-component exercise intervention.

Behavioral: Frailty Intervention

Control group

NO INTERVENTION

Respondents in the control group will not receive any nutritional education or exercise intervention activities.

Interventions

Frailty Intervention BEHAVIORAL

In overall, participants will attend one session of frailty talk, 22 sessions of low to moderate intensity of multi-components exercise course and 6 session of nutrition education interventions. Both nutritional education and exercise intervention will be conducted concurrently for a 12-week (3-month) of intervention period. Noted that every session will be held in PPR flats' facility area or hall around 60 minutes that will be conducted by the dietitian or nutritionist and physiotherapist from the research team.

Also known as: FITNESS

Frailty Intervention group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Putra Malaysia: lead

Study Sites (1)

Projek Perumahan Rakyat (PPR)

Kuala Lumpur, Kuala Lumpur, 51200, Malaysia

Location

Study Officials

• Siti Nur'Asyura binti Adznam

  Universiti Putra Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: February 23, 2020
• First Posted: March 31, 2020
• Study Start: June 14, 2022
• Primary Completion: December 9, 2022
• Study Completion: December 9, 2022
• Last Updated: May 15, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)