Salutogenic Frailty Prevention Program for Women Aged 55 Years and Over

Study Overview
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Brief Summary
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Frailty is a condition of reduced the capacity in multiple body systems and causing adverse outcomes because of decreasing the ability to cope with stressors. Female sex, the changes of the body imposed by ageing, and coping strategies for stressors are causal mechanisms in the development of frailty. This project is designed with the salutogenic model that is focused on the concepts of health, stress, and coping. The aim of this project is to assess the effect of Salutogenic Frailty Prevention Program on promoting sense of coherence and preventing the development of frailty in women aged 55 years and over

Official Title
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The Effect of Salutogenic Model Based Frailty Prevention Program on Development of Frailty and Sense of Coherence in Women Aged 55 Years and Over

Conditions
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Salutogenesis, Frailty, Frailty Syndrome, Sense of Coherence

Intervention / Treatment
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* Behavioral: Salutogenic Frailty Prevention Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing to participate in the study Woman aged 55 years and over Pre-frail (Total FRAIL scale score 1 or 2) Has Internet access Exclusion Criteria: To be semi-dependent and dependent according to the Katz Daily Activities Activity Scale To have any cognitive, psychiatric and neurological disorders To have any surgical operation in the past 3 month Communication barrier (due to hearing/vision impairment)

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Experimental: SAFRAPP Intervention Participants in this group will receive a 6-week SAFRAPP intervention, comprising of laughter yoga, health education and case management. SAFRAPP will be conducted on social media (Facebook and WhatsApp). | Behavioral: Salutogenic Frailty Prevention Program<br>* Laughter yoga: The first component of intervention is the laughter yoga that is a combination of warm up exercise, deep breathing exercises, childlike playfulness and laughter exercises. Each session of laughter yoga will be offered twice a weekly and 40 minutes each time. Health education: The second component of intervention consisted of six health issues which are health, frailty and generalized sources of resistance for frailty, the most common medical condition and medication use, physical activity, healthy diet, falls prevention and cognitive and psychosocial well-being. Case management: The third component of intervention is activities that determine each participant's health needs with the Omaha System and support them for the use of appropriate resources.<br>|
| No Intervention: Control Grup<br>The control group will not receive any intervention during the study. Participants in the control group will take the same program after the study is completed. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sense of Coherence | Sense of coherence assesses an individual's orientation and internal strengths. It consists of 13 items rated on a 7-point Likert scale, and has three components including comprehensibility (5-item), manageability (4-item) and meaningfulness (4-item) | Baseline, 3 months, 6 months, 9 months | 
| Change in FRAIL scale | The FRAIL scale consists of 5 items (fatigue, resistance, ambulation, illnesses, loss of weight). Frail scale scores range from 0-5 and represent frailty status as frail (3-5), pre-frail (1-2), and robust (0). | Baseline, 3 months, 6 months, 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in The World Health Organisation- Five Well-Being Index (WHO-5) | The five-items Well-Being Index will be used to assess participants' psychological well-being. | Baseline, 3 months, 6 months, 9 months | 
| Change in health-related quality of life | The EQ-5D-3L descriptive system evaluates the participants' health state in the five dimensions including mobility, self-care, usual activities, pain/discomfort and anxiety/depression. | Baseline, 3 months, 6 months, 9 months | 
| Change in EQ-VAS | EQ visual analogue scale (EQ-VAS) is a vertical scale that assesses the participant's own judgement regarding their health between 0 and 100. | Baseline, 3 months, 6 months, 9 months | 
| Change in number of falls | Participants will be asked about the number of falls in the past three months | Baseline, 3 months, 6 months, 9 months | 
| Change in fear of fall | Participants will be asked a single question: Are you afraid of falling? The possible answers were never afraid, sometimes afraid, afraid, and always afraid. | Baseline, 3 months, 6 months, 9 months | 
| Change in number of emergency admissions | Participants will be asked about the number of the emergency visit in the past 3 months | Baseline, 3 months, 6 months, 9 months |