Salutogenic Frailty Prevention Program for Women Aged 55 Years and Over (SAFRAPP)

March 5, 2021 updated by: Merve ALTINER YAS, Istanbul University - Cerrahpasa (IUC)

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline, 3 months, 6 months, 9 months
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).
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)
Time Frame: Baseline, 3 months, 6 months, 9 months
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
Time Frame: Baseline, 3 months, 6 months, 9 months
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
Time Frame: Baseline, 3 months, 6 months, 9 months
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
Time Frame: Baseline, 3 months, 6 months, 9 months
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
Time Frame: Baseline, 3 months, 6 months, 9 months
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
Time Frame: Baseline, 3 months, 6 months, 9 months
Participants will be asked about the number of the emergency visit in the past 3 months
Baseline, 3 months, 6 months, 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa (IUC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2021

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

January 1, 2022

Study Registration Dates

First Submitted

March 2, 2021

First Submitted That Met QC Criteria

March 5, 2021

First Posted (Actual)

March 8, 2021

Study Record Updates

Last Update Posted (Actual)

March 8, 2021

Last Update Submitted That Met QC Criteria

March 5, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IU-Cerrahpasa

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Frailty

Clinical Trials on Salutogenic Frailty Prevention Program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe