Salutogenic Frailty Prevention Program for Women Aged 55 Years and Over

NCT ID: NCT04787432

Last Updated: 2021-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-31

Study Completion Date

2022-01-31

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

Detailed Description

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Conditions

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Frailty Frailty Syndrome Salutogenesis Sense of Coherence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention

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).

Group Type EXPERIMENTAL

Salutogenic Frailty Prevention Program

Intervention Type BEHAVIORAL

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.

Control Grup

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

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)
Minimum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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Merve ALTINER YAS

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Merve ALTINER YAS, MSc

Role: CONTACT

+90 (212) 404 03 00 ext. 27042

Selda SECGINLI, PhD

Role: CONTACT

References

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Yas MA, Secginli S. Salutogenic Model-Based Frailty Prevention Program for Pre-Frail Women Aged 55 Years and Over (SAFRAPP): A Study Protocol for a Randomized Controlled Trial. Res Theory Nurs Pract. 2022 Apr 1;36(2):215-232. doi: 10.1891/RTNP-2021-0098.

Reference Type DERIVED
PMID: 35584890 (View on PubMed)

Other Identifiers

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IU-Cerrahpasa

Identifier Type: -

Identifier Source: org_study_id

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