Clinical trial NCT04327544: A Health Promotion Program to Prevent Frailty and Improve Frailty Status Among Pre-frail Elderly: Frailty Intervention Through Nutrition Education and Exercises.
Official title: Nutritional Education and Exercise Intervention in Preventing Frailty Among Pre-frail Malaysian Elderly in PPR Flats Kuala Lumpur
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frail Elderly Syndrome
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
First posted: 2020-03-31
Enrollment: 59
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in Frailty score
timeFrame: 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).
measure: Changes of Frailty status
timeFrame: 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:
measure: Changes in knowledge, attitude and practice (KAP) towards frailty, nutrition and exercise
timeFrame: 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).
measure: Changes in dietary intake
timeFrame: 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).
measure: Changes in cognitive status
timeFrame: 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).
measure: Changes in functional ability
timeFrame: 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).
measure: Changes in mobility status
timeFrame: 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).
measure: Changes in risk of falls
timeFrame: 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).
measure: Changes in body mass index
timeFrame: 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).
measure: Changes in mid upper arm circumference (MUAC)
timeFrame: 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).
measure: Changes in calf circumference (CC)
timeFrame: 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).
measure: Changes in percentage of total body fat (%TBF)
timeFrame: 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).
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Projek Perumahan Rakyat (PPR)
state: Federal Territory Of Kuala Lumpur
Study officials:
affiliation: Universiti Putra Malaysia
name: Siti Nur'Asyura binti Adznam
role: PRINCIPAL_INVESTIGATOR
References: