Clinical trial NCT06265480: FallFitness Fallprevention Program for Older Adults
Official title: FallFitness Fallprevention Exercise Program for Community-dwelling Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fall Injury
Fall
Self Efficacy
Lead sponsor: Dalarna University
Sponsor class: OTHER
Collaborators: name: Sormland County Council, Sweden
First posted: 2024-02-20
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised Controlled Trial
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Physical function by Short Physical Performance Battery
timeFrame: Baseline and at two months follow up
Secondary outcomes:
measure: Self-efficacy (balance confidence)
timeFrame: Baseline and at two months follow up
measure: Fear of Falling
timeFrame: Baseline and at two months follow up
measure: EuroQoL-5 Dimension Questionnaire (EQ-5D)
timeFrame: Baseline and at two months follow up
measure: Fallfrequency
timeFrame: A total of 12 months falldiary from baseline
measure: Falling techniques
timeFrame: Baseline and at two months follow up
measure: Handgrip strength
timeFrame: Baseline and at two months follow up
Other outcomes:
Locations:
city: Eskilstuna
country: Sweden
facility: Marina Arkkukangas
state: Sormland
Study officials:
affiliation: Dalarna University
name: Marina Arkkukangas, PhD
role: PRINCIPAL_INVESTIGATOR
References: