FallFitness Fallprevention Program for Older Adults

NCT06265480 | Recruiting

• 1 other identifier: 2023-04577-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Fall Injury; Fall; Self Efficacy

Outcome Measures

Primary Outcomes (1)

• Physical function by Short Physical Performance Battery

  Balance, strength and walking

  Baseline and at two months follow up

Secondary Outcomes (6)

• Self-efficacy (balance confidence)

  Baseline and at two months follow up

• Fear of Falling

  Baseline and at two months follow up

• EuroQoL-5 Dimension Questionnaire (EQ-5D)

  Baseline and at two months follow up

• Fallfrequency

  A total of 12 months falldiary from baseline

• Falling techniques

  Baseline and at two months follow up

Study Arms (2)

FallFitness intervention group

EXPERIMENTAL

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

Other: FallFitness intervention group

Control group

NO INTERVENTION

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

Interventions

FallFitness intervention group OTHER

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

FallFitness intervention group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• Fluent in Swedish language in both speech and writing

You may not qualify if:

• 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

Sponsors & Collaborators

• Dalarna University: lead
• Sormland County Council, Sweden: collaborator

Study Sites (1)

Marina Arkkukangas

Eskilstuna, Sormland, Sweden

RECRUITING

Related Publications (2)

• 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.

  PMID: 40621091 DERIVED

• 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.

  PMID: 39616365 DERIVED

Study Officials

• Marina Arkkukangas, PhD

  Dalarna University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marina Arkkukangas, PhD

CONTACT

+46 (0)706468868; maau@du.se

Michail Tonkonogi, Professor

CONTACT

+46(0)708206435; mtn@du.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Study will be singled blinded (assessors)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: Randomised Controlled Trial

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: February 20, 2024
• Study Start: March 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: December 31, 2025
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

SE (1)