AzTrials
AzTrials

Frail Elderly SyndromeFINENCT04327544

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

A study testing Frailty Intervention in people with Frail Elderly Syndrome, run by Universiti Putra Malaysia at 1 site in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Frail Elderly Syndrome
What is being tested?
Frailty Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
1 siteMalaysia
Study dates
14 Jun 2022to 9 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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 locations and contacts

1 site in 1 country.

Malaysia1 site
  • Projek Perumahan Rakyat (PPR)

    Kuala Lumpur, Kuala Lumpur, 51200

Other trials in Malaysia

About this study

Official title: Nutritional Education and Exercise Intervention in Preventing Frailty Among Pre-frail Malaysian Elderly in PPR Flats Kuala Lumpur

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.

Being tested
Frailty Intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Frailty InterventionBehavioural

    Also called FITNESS

    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.

Study groups in NCT04327544
Study groupRoleWhat they receive
Frailty Intervention groupExperimentalA multi-domain intervention program that includes nutrition education and low to moderate multi-component exercise intervention.
Receives: Behavioral: Frailty Intervention
Control groupNo interventionRespondents in the control group will not receive any nutritional education or exercise intervention activities.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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).

  2. 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

    Measured: 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)
  1. Changes in knowledge, attitude and practice (KAP) towards frailty, nutrition and exercise

    The KAP questions will be developed prior to data collection to measure the construct of knowledge, attitude and practice in relation to frailty, nutrition and exercise among elderly. The questions consisted of items based on the content of the developed educational materials. A validation and reliability study will be conducted after it is developed. The result will be in term of score. The higher score in knowledge indicate better knowledge. Higher score in attitude indicate more positive attitude and higher score in practice indicate healthier lifestyle practice by the participant.

    Measured: 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).

  2. Changes in dietary intake

    The amount of food items consumed by the respondents in the past week will be recorded by the validated Malay language of Diet History Questionnaire (DHQ) via interview method. The data will be analysed using the Nutritionist Pro TM Diet Analysis Software, then will be compared to the Malaysian Recommended Nutrient intake.

    Measured: 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).

  3. Changes in cognitive status

    This study will used the validated Malay language version of Mini-Mental State Examination (M-MMSE) questionnaire to assess the cognitive functioning of the respondents. The M-MMSE is an 11-question measure that tests five areas of cognitive function: orientation (2 items), registration (1 item), attention and calculation (1 item), recall (1 item), and language (6 items). The maximum score is 30. A score of 23 or lower is indicative of cognitive impairment.

    Measured: 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).

  4. Changes in functional ability

    The well-established Malay language of Lawton Instrumental Activities of Daily Living (IADL) questionnaire will be used to assess the respondents' ability to perform eight daily activities (i.e. ability to use telephone, shopping, preparing meals, housekeeping, doing laundry, using public transport, taking medications, and handling finances). Presence of 'functional disability' will be defined as having difficulty or needing help in at least one of these 8 items IADL activities, while normal functioning will be defined if one can perform all 8 activities independently.

    Measured: 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).

  5. Changes in mobility status

    A well-established Malay language of Short Physical Performance Battery (SPPB) will be used for this study to test the respondents' mobility status to evaluate lower limb extremity functioning in three components (balance test, gait speed test and repeated chair stand test). There are three components namely: 1) balance test (the ability to stand for 10 sec with the feet together in the side-by-side, semi-tandem, and tandem positions) 2) gait speed test (time to walk 4 metres) and 3) repeated chair stand test (time to rise from a chair and return to the seated position 5 times). A score ranging from 0 to 4 (0=inability to complete the task; 4=highest level of function) will be scored for each task of SPPB with the sum of these three tests (0-12) reflecting the complete measurement of physical function. Thus, lower scores on the SPPB reflect higher odds of mobility-related disability.

    Measured: 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).

  6. Changes in risk of falls

    The Malay language of Berg Balance Scale (BBS) will be used to assess the risk of falls among the respondents by assessing the performance of 14 different functional tasks. The different tasks including ability to sit, stand, reach, lean over, turn and look over each shoulder, turn in a complete circle, and step. The BBS, which rates each performance from 0 (cannot perform) to 4 (normal performance), with the total possible score on the BBS is 56, indicating excellent balance. The presence of high risk of falls will be scored within 0-20.

    Measured: 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).

  7. Changes in body mass index

    Body Mass Index (BMI) will be calculated as weight (kg) divided by the square of the height (m2) of either standing height or alternative height. The classification for BMI is based on World Health Organization; value of less than 18.5 kg/m2 and more than 24.9 kg/m2 indicates underweight and overweight respectively. Seca 803 Digital Weight Scale will be used to measure body weight of the respondents in light clothing (without shoes) to the nearest 0.1 kilogram. Standing height will be taken using SECA portable stadiometer (SECA-213 model) to the nearest 0.1 centimeter with the subject standing barefoot. Subjects who are found to have kyphosis problem or difficulty to stand straight will be replaced with alternative height (demi-span) measurement using equations developed among Malaysian elderly.

    Measured: 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).

  8. Changes in mid upper arm circumference (MUAC)

    Body part circumference, MUAC will be measured using a flexible non-stretchable tape (SECA-201 model). MUAC is measured to indicate the loss of peripheral muscle mass and is an indicator for upper-body muscle mass and recommended to use to assess the nutritional status of elderly. MUAC need to identify the midpoint of the bare non-dominant arm first, then measure circumference comfortably round the arm at the midpoint. Reading will be taken twice to the nearest 0.1cm and average circumference will be calculated. A MUAC value of less than 23.0 cm for men and 22.0 cm for women indicates loss of peripheral muscle mass.

    Measured: 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).

  9. Changes in calf circumference (CC)

    Body part circumference, CC will be measured using a flexible non-stretchable tape (SECA-201 model). CC measurement is to indicate muscle loss especially in the lower limb and considered a pertinent marker of the nutritional status in the elderly. For CC, the measuring tape will be wrapped comfortably around the calf (non-dominant leg) at the widest part while respondents are sitting down and recorded to the nearest 0.1cm. The criterion to indicate muscle loss, especially in the lower limb was based on the local classification for Malaysian elderly with a value of less than 30.1 cm for men and 27.3 cm for women respectively.

    Measured: 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).

  10. Changes in percentage of total body fat (%TBF)

    The %TBF refers to the amount of body fat mass in regard to the total body weight expressed as a percentage. It will be determined by the OMRON body fat analyzer (HBF-375 model). Prior to the measurement, respondents will be ensured to remove all metal accessories (i.e. necklace, rings, earrings, watch, cell phones and bracelets) that might interfere the reading. Information like age, gender and height will be set into the analyzer. Respondents will be required to stand on weighing platform with bare feet in contact with the metal parts while both hands holding tightly the grip electrodes with outstretched arms. The %TBF of the respondents will be classified into certain ranges for person 18 years of age and older. %TBF that is low than 5 and 8 indicate too low muscle while more than 25 and 32 indicate too high for male and female respectively.

    Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2020
  2. Study start14 Jun 2022
  3. Primary completion9 Dec 2022
  4. Study completion9 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04327544
Sponsor's protocol ID
GP-IPS/2017/9547700
Acronym
FINE
Status last verified
May 2023
First submitted
23 Feb 2020
Last updated
15 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Frailty Intervention in people with Frail Elderly Syndrome, run by Universiti Putra Malaysia at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Frailty score (time frame: 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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2023.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in