Salutogenic Frailty Prevention Program for Women Aged 55 Years and Over

Frailty Clinical Trial

— SAFRAPP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04787432
• Other study ID #: IU-Cerrahpasa
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2021
• Est. completion date: January 2022

Study information

• Verified date: March 2021
• Source: Istanbul University-Cerrahpasa
• Contact: Merve ALTINER YAS, MSc
• Phone: +90 (212) 404 03 00
• Email: altinermerve90[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 84
• Est. completion date: January 2022
• Est. primary completion date: September 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 55 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Frailty
• Frailty Syndrome
• Salutogenesis
• Sense of Coherence

Intervention

Behavioral:
• Salutogenic Frailty Prevention Program
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University-Cerrahpasa

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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