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Salutogenic Frailty Prevention Program for Women Aged 55 Years and Over

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04787432
Acronym
SAFRAPP
Enrollment
84
Registered
2021-03-08
Start date
2021-03-31
Completion date
2022-01-31
Last updated
2021-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frailty, Frailty Syndrome, Salutogenesis, Sense of Coherence

Brief 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

Interventions

BEHAVIORALSalutogenic 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.

Sponsors

Istanbul University - Cerrahpasa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
55 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Change in Sense of CoherenceBaseline, 3 months, 6 months, 9 monthsSense 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)
Change in FRAIL scaleBaseline, 3 months, 6 months, 9 monthsThe 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).

Secondary

MeasureTime frameDescription
Change in EQ-VASBaseline, 3 months, 6 months, 9 monthsEQ visual analogue scale (EQ-VAS) is a vertical scale that assesses the participant's own judgement regarding their health between 0 and 100.
Change in number of fallsBaseline, 3 months, 6 months, 9 monthsParticipants will be asked about the number of falls in the past three months
Change in The World Health Organisation- Five Well-Being Index (WHO-5)Baseline, 3 months, 6 months, 9 monthsThe five-items Well-Being Index will be used to assess participants' psychological well-being.
Change in number of emergency admissionsBaseline, 3 months, 6 months, 9 monthsParticipants will be asked about the number of the emergency visit in the past 3 months
Change in fear of fallBaseline, 3 months, 6 months, 9 monthsParticipants will be asked a single question: Are you afraid of falling? The possible answers were never afraid, sometimes afraid, afraid, and always afraid.
Change in health-related quality of lifeBaseline, 3 months, 6 months, 9 monthsThe 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.

Contacts

Primary ContactMerve ALTINER YAS, MSc
altinermerve90@gmail.com+90 (212) 404 03 00
Backup ContactSelda SECGINLI, PhD
secginli@istanbul.edu.tr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026