FallFitness Fallprevention Program for Older Adults

Self Efficacy Clinical Trial

Official title:

FallFitness Fallprevention Exercise Program for Community-dwelling Older Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06265480
• Other study ID #: 2023-04577-01
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Dalarna University
• Contact: Marina Arkkukangas, PhD
• Phone: +46 (0)706468868
• Email: maau[@]du.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overall aim with this project is to collaborate with four organisations for retired persons located in a small region of middle Sweden. The project aims to test and evaluate a newly developed group-based fall prevention exercise program regarding the effects and experiences of both leading and participating in the intervention. The design of the study is a randomised controlled trial including a total of 100 participants (60+), 50 participants in the intervention and 50 participants in the control group.

Description:

Research questions of interest in the project are:

1. Can an eight week (eight sessions) high intensity group based fall prevention program increase strength, balance, activity level, quality of life, self-efficacy as well as reduce sedentary behavior, fear of falling and fall frequency in older adults?

2. Can older adults learn fall techniques by participating in an eight-week (eight-session) high intensity group based fall prevention program?

3. What experiences are there from the trained leaders and the participants in the intervention?

4. How can the program be implemented in the organisations for retired persons, facilitators and barriers?

A total of at least 10 volunteers will be recruited from the organisations for retired persons and trained to be instructors of the FallFitness program. These FallFitness instructors will lead the intervention groups in the planned randomised controlled trial.

For the 50 participants randomized to the intervention group a eight program including six different central components, strength, balance, self-efficacy, motor skills, and falling technique will be introduced. Estimation of about ten participants in each group with a total of five groups are planned.

Materials needed are mainly soft judo carpets. The exercise takes place in groups and most of the exercises are done in pairs, which has been a successful concept in previously research on a similar programme, Judo4Balance.

Outcome measures of interest:

Strength, balance, quality of life, activity level, fear of falling, confidence in one's own ability to perform various activities without falling, fall frequency and falling techniques. Further a "train the trainer" approach will be evaluated for implementation and a long term perspective of fallprevention.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• 60 years of age

• Fluent in Swedish language in both speech and writing

Exclusion Criteria:

• Physically weak, cannot sit upright without support and/or holding up the neck in a lying position and or rolls backwards

• Coronary artery disease and unstable angina

• Recently cataract treatment

Related Conditions & MeSH terms

• Fall
• Fall Injury
• Self Efficacy

Intervention

Other:
• FallFitness intervention group
Eight week group-based fallprevention intervention. A total of eight session (1-hour once a week).

Locations

Country	Name	City	State
Sweden	Marina Arkkukangas	Eskilstuna	Sormland

Sponsors (2)

Lead Sponsor	Collaborator
Dalarna University	Sormland County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical function by Short Physical Performance Battery	Balance, strength and walking	Baseline and at two months follow up
Secondary	Self-efficacy (balance confidence)	Falls self-efficacy	Baseline and at two months follow up
Secondary	Fear of Falling	Questionnaire	Baseline and at two months follow up
Secondary	EuroQoL-5 Dimension Questionnaire (EQ-5D)	Quality of life questionnaire	Baseline and at two months follow up
Secondary	Fallfrequency	Falldiary every month	A total of 12 months falldiary from baseline
Secondary	Falling techniques	Falling backwards and sideways	Baseline and at two months follow up
Secondary	Handgrip strength	Handgrip strength measured by hand dynamometer	Baseline and at two months follow up