FrailtySAFRAPPNCT04787432
Salutogenic Frailty Prevention Program for Women Aged 55 Years and Over
A study testing Salutogenic Frailty Prevention Program in people with Frailty and Frailty Syndrome, run by Istanbul University - Cerrahpasa.
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. Read more about this study
- Who is it for?
- Ages 55 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Frailty, Frailty Syndrome, Salutogenesis
- What is being tested?
- Salutogenic Frailty Prevention Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- Mar 2021to Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing to participate in the study
- Woman aged 55 years and over
- Pre-frail (Total FRAIL scale score 1 or 2)
- Has Internet access
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet.
Selda SECGINLI, PhD contact
About this study
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
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
- Conditions
- Frailty, Frailty Syndrome, Salutogenesis, Sense of Coherence
- Being tested
- Salutogenic Frailty Prevention Program
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salutogenic Frailty Prevention ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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). Receives: Behavioral: Salutogenic Frailty Prevention Program |
| Control Grup | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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).
Measured: Baseline, 3 months, 6 months, 9 months
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: Baseline, 3 months, 6 months, 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study startMar 2021 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve ALTINER YAS, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04787432
- Sponsor's protocol ID
- IU-Cerrahpasa
- Acronym
- SAFRAPP
- Status last verified
- Mar 2021
- First submitted
- 2 Mar 2021
- Last updated
- 8 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yas MA, Secginli S. Effects of a Salutogenic Model-Based Frailty Prevention Program (SAFRAPP) in pre-frail women: a randomized controlled trial. BMC Nurs. 2025 Sep 26;24(1):1200. doi: 10.1186/s12912-025-03832-0.
PubMed 41013383Yas 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.
PubMed 35584890
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04787432
- Acronym / sponsor ID
- SAFRAPP / IU-Cerrahpasa
- Conditions
- Frailty, Frailty Syndrome, Salutogenesis, Sense of Coherence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- Mar 2021 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 8 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Salutogenic Frailty Prevention ProgramExperimental: 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). |
| Control Grup | No intervention | –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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Willing to participate in the study
- Woman aged 55 years and over
- Pre-frail (Total FRAIL scale score 1 or 2)
- Has Internet access
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Salutogenic Frailty Prevention ProgramLaughter 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. | Behavioural | Intervention |
Primary outcome
Change in Sense of Coherence
Time frame: Baseline, 3 months, 6 months, 9 months
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)
Change in FRAIL scale
Time frame: Baseline, 3 months, 6 months, 9 months
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).
6 secondary outcomes
Change in The World Health Organisation- Five Well-Being Index (WHO-5)
Time frame: Baseline, 3 months, 6 months, 9 months
Change in health-related quality of life
Time frame: Baseline, 3 months, 6 months, 9 months
Change in EQ-VAS
Time frame: Baseline, 3 months, 6 months, 9 months
Change in number of falls
Time frame: Baseline, 3 months, 6 months, 9 months
Change in fear of fall
Time frame: Baseline, 3 months, 6 months, 9 months
Change in number of emergency admissions
Time frame: Baseline, 3 months, 6 months, 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
- Derived from this study: PubMed 41013383Yas MA, Secginli S. Effects of a Salutogenic Model-Based Frailty Prevention Program (SAFRAPP) in pre-frail women: a randomized controlled trial. BMC Nurs. 2025 Sep 26;24(1):1200. doi: 10.1186/s12912-025-03832-0.
- Derived from this study: PubMed 35584890Yas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selda SECGINLI, PhD contact
Questions about this trial
What is this clinical trial studying?
A study testing Salutogenic Frailty Prevention Program in people with Frailty and Frailty Syndrome, run by Istanbul University - Cerrahpasa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Merve ALTINER YAS, MSc (+90 (212) 404 03 00 ext. 27042, altinermerve90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sense of Coherence (time frame: Baseline, 3 months, 6 months, 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04787432, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2021; AzTrials last refreshed its copy on 7 Nov 2026.