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

May 12, 2023 updated by: Nurul Izzati binti Mohd Suffian, Universiti Putra Malaysia

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
59

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Federal Territory Of Kuala Lumpur
      • Kuala Lumpur, Federal Territory Of Kuala Lumpur, Malaysia, 51200
        • Projek Perumahan Rakyat (PPR)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Frailty Intervention group
A multi-domain intervention program that includes nutrition education and low to moderate multi-component exercise intervention.
Behavioral: Frailty Intervention
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.
Other Names:
  • FITNESS
No Intervention: Control group
Respondents in the control group will not receive any nutritional education or exercise intervention activities.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
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
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).
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in knowledge, attitude and practice (KAP) towards frailty, nutrition and exercise
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 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.
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
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 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.
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
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).
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.
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
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 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.
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
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).
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.
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 risk of falls
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 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.
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 body mass index
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).
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.
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 mid upper arm circumference (MUAC)
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).
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.
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 calf circumference (CC)
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).
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.
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 percentage of total body fat (%TBF)
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 %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.
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universiti Putra Malaysia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Siti Nur'Asyura binti Adznam, Universiti Putra Malaysia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 14, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 9, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 9, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 31, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GP-IPS/2017/9547700

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings