FallFitness Fallprevention Program for Older Adults

NCT ID: NCT06265480

Last Updated: 2024-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Fall Injury Fall Self Efficacy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised Controlled Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Study will be singled blinded (assessors)

Study Groups

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FallFitness intervention group

FallFitness 8-weeks exercise program, pre-and post assessment.

Group Type EXPERIMENTAL

FallFitness intervention group

Intervention Type OTHER

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

Control group

No treatment, standard information about fall prevention, pre-and post assessment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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FallFitness intervention group

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sormland County Council, Sweden

OTHER

Sponsor Role collaborator

Dalarna University

OTHER

Sponsor Role lead

Responsible Party

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Marina Arkkukangas

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marina Arkkukangas, PhD

Role: PRINCIPAL_INVESTIGATOR

Dalarna University

Locations

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Marina Arkkukangas

Eskilstuna, Sormland, Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Marina Arkkukangas, PhD

Role: CONTACT

+46 (0)706468868

Michail Tonkonogi, Professor

Role: CONTACT

+46(0)708206435

Facility Contacts

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Marina Arkkukangas, PhD

Role: primary

+46 (0)706468868

Michail Tonkonogi, Professor

Role: backup

+46(0)708206435

References

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Arkkukangas M, Stromqvist Baathe K, Tonkonogi M, Liljeroos M. More Than Just Exercise: Older Adults' Experience of the Peer-Led Group-Based FallFitness Program. Clin Interv Aging. 2025 Jul 1;20:931-939. doi: 10.2147/CIA.S527142. eCollection 2025.

Reference Type DERIVED
PMID: 40621091 (View on PubMed)

Arkkukangas M, Baathe KS, Hamilton J, Hassan A, Tonkonogi M. FallFitness exercise program provided using the train-the-trainer approach for community-dwelling older adults: a randomized controlled trial. BMC Geriatr. 2024 Nov 30;24(1):983. doi: 10.1186/s12877-024-05575-0.

Reference Type DERIVED
PMID: 39616365 (View on PubMed)

Other Identifiers

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2023-04577-01

Identifier Type: -

Identifier Source: org_study_id

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