FallFitness Fallprevention Program for Older Adults

FallFitness Fallprevention Exercise Program for Community-dwelling Older Adults

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.

Study Overview

• Status: Recruiting
• Conditions: Fall; Self Efficacy; Fall Injury
• Intervention / Treatment: Other: FallFitness intervention 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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marina Arkkukangas, PhD; Phone Number: +46 (0)706468868; Email: maau@du.se
• Study Contact Backup: Name: Michail Tonkonogi, Professor; Phone Number: +46(0)708206435; Email: mtn@du.se

Study Locations

• Sweden
  • Sormland
    • Eskilstuna, Sormland, Sweden
      • Recruiting
      • Marina Arkkukangas
      • Contact: Marina Arkkukangas, PhD; Phone Number: +46 (0)706468868; Email: maau@du.se
      • Contact: Michail Tonkonogi, Professor; Phone Number: +46(0)708206435; Email: mtn@du.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FallFitness intervention group; FallFitness 8-weeks exercise program, pre-and post assessment.	Other: FallFitness intervention group; Eight week group-based fallprevention intervention. A total of eight session (1-hour once a week).
No Intervention: Control group; No treatment, standard information about fall prevention, pre-and post assessment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical function by Short Physical Performance Battery	Balance, strength and walking	Baseline and at two months follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-efficacy (balance confidence)	Falls self-efficacy	Baseline and at two months follow up
Fear of Falling	Questionnaire	Baseline and at two months follow up
EuroQoL-5 Dimension Questionnaire (EQ-5D)	Quality of life questionnaire	Baseline and at two months follow up
Fallfrequency	Falldiary every month	A total of 12 months falldiary from baseline
Falling techniques	Falling backwards and sideways	Baseline and at two months follow up
Handgrip strength	Handgrip strength measured by hand dynamometer	Baseline and at two months follow up

Collaborators and Investigators

• Sponsor: Dalarna University
• Collaborators: Sormland County Council, Sweden
• Investigators: Principal Investigator: Marina Arkkukangas, PhD, Dalarna University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: February 8, 2024
• First Submitted That Met QC Criteria: February 16, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2023-04577-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No