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

NCT ID: NCT04327544

Last Updated: 2023-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-14
• Study Completion Date: 2022-12-09

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Frailty Intervention group

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

Group Type: EXPERIMENTAL

Frailty Intervention

Intervention Type: 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.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

FITNESS

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universiti Putra Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Nurul Izzati binti Mohd Suffian

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Siti Nur'Asyura binti Adznam

Role: PRINCIPAL_INVESTIGATOR

Universiti Putra Malaysia

Locations

Projek Perumahan Rakyat (PPR)

Kuala Lumpur, Kuala Lumpur, Malaysia

Countries

Malaysia

Other Identifiers

GP-IPS/2017/9547700

Identifier Type: -

Identifier Source: org_study_id