NCT04294342

Brief Summary

This is a control study with a 2-group pretest-posttest design investigating the effects of a 10-week judo-inspired exercise program (Judo4Balance) for physical functions, self-efficacy, activity level, and fall techniques among working adults \& part-time working retired people. Falls constitute a common and severe threat to older men and women's health worldwide. However, falls are not just a problem of advanced age, studies have been reporting that falls are a problem at all ages. Nevertheless, falls are under-studied, particularly among young and middle-aged adults (working age adults). For all fall-related injuries among adults, the proportions have been reported to be 32.3% among older adults, 35.3% among middle-aged adults, and 32.3% among younger adults in the United States. This indicates that falls and fall related injuries represent a significant threat to public health at all ages. Therefore, new innovative ways of prevention is much needed and needs to be studied.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 1, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

July 13, 2022

Status Verified

July 1, 2022

Enrollment Period

1.8 years

First QC Date

March 1, 2020

Last Update Submit

July 11, 2022

Conditions

Keywords

Fall preventionPhysical trainingjudojudo4BalanceBreak fallsHealth and SafetyFalling at work

Outcome Measures

Primary Outcomes (3)

  • Change in participants "break fall" competence/skill

    Two tests have been developed to test the skills for falling backwards as well as falling forwards in a safe setting, with progressive difficulty. Four Judo puzzle mats are needed for the test. The "break fall" technique froward and backward are graded from a 0-4 point scale. (where 0 is not being able to lay down and get up from the floor and 4 is being able to fall safely from a standing up position, thus representing the best score).

    Before and after 10 weeks of training

  • Change in participants' fall efficacy after 10 weeks

    The change in falls-efficacy will be measured through - Modified Falls-Efficacy Scale - Falls Efficacy Scale-Swedish version (FES-S) and Falls Efficacy Scale-Swedish version for working age (FES-S-W) is used to measure the self-confidence in the ability to perform various daily activities without falling.The FES-S-W was extended with six additional questions, with the aim to ask people of working age about their confidence related to falling as well as their confidence of not getting hurt when falling. The original instrument consists of 13 items and the extended test 19 items. Each item is rated from 0 to 10, with a maximum score of 130/190 points, which represents the highest level of self-efficacy. The original instrument has been shown to have high test-retest reliability.

    Before and after 10 weeks of training

  • Change in Balance

    The Mini-BESTest and Mini-BESTest- W were used to measure balance. The original test includes 14 different tasks on 4 subscales. The extended test includes six additional items: feet shoulder-width apart, on toes for extended time (30 seconds); feet together, eyes closed and on toes; walking backwards; walking backwards on a line; standing on one leg on a foam surface left/right; change in gait speed backwards; and step over obstacles backwards. All tasks are graded from 0 to 2 points, with a total maximum score of 28 points for the original test and 40 points for the extended test. The higher the score the better the performance. The original test has high reported test-retest reliability and interrater reliability.

    Before and after the 10 weeks of training

Secondary Outcomes (4)

  • Short Physical Performance Battery (SPPB-W)

    Before and after 10 weeks of training

  • Change in level of Physical Activity

    Before and after 10 weeks training

  • Judo4Balance Instructors perception of the suitability and effectiveness of the program

    After the 10 weeks of training

  • Judo4Balance - Participant Survey

    After the 10 week program

Study Arms (2)

Participants in 10 week Judo Inspired Exercise program

ACTIVE COMPARATOR

The intervention included 10 sessions, using a 10-week (45-50 minutes /week) pre-established program called Judo4Balance, a structured exercise program which consists of three blocks. All sessions include: Balance, Strength, power and break fall exercises. The intervention group i tested before and after the 10 week exercise.

Behavioral: Active Comparator: Participants in 10 week Judo Inspired Exercise program

Control Group

NO INTERVENTION

The subjects in the control group go about their normal life for 10 weeks without any intervention. The control group is tested before and after the 10 week period.

Interventions

The intervention included 10 sessions, using a 10-week (45-50 minutes /week) pre-established program called Judo4Balance, a structured exercise program. Each session consisting of warm-up, balance, strength, power and break fall exercises. There is clear a progression within the 10 week program in three main blocks. Block 1: learning the exercises and principle movements, Block 2 more resistance and advance falling techniques, Block 3 Power training and falling strategies from stand up positions.

Also known as: Judo4Balance: Fall-Preventive Exercise Group
Participants in 10 week Judo Inspired Exercise program

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 18 years of age. Understanding oral and written communication in Swedish.

You may not qualify if:

  • Physically fragile individuals that are so weak that they cannot sit up without support or not being able to hold up neck when laying on the floor or rolling backwards
  • Individuals with aortic aneurysm, angina pectoris or recently has had a cataract operation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dalarna University

Falun, Dalarna County, 791 88, Sweden

Location

Related Publications (5)

  • Timsina LR, Willetts JL, Brennan MJ, Marucci-Wellman H, Lombardi DA, Courtney TK, Verma SK. Circumstances of fall-related injuries by age and gender among community-dwelling adults in the United States. PLoS One. 2017 May 4;12(5):e0176561. doi: 10.1371/journal.pone.0176561. eCollection 2017.

  • Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994 Mar;49(2):M85-94. doi: 10.1093/geronj/49.2.m85.

  • Franchignoni F, Horak F, Godi M, Nardone A, Giordano A. Using psychometric techniques to improve the Balance Evaluation Systems Test: the mini-BESTest. J Rehabil Med. 2010 Apr;42(4):323-31. doi: 10.2340/16501977-0537.

  • Hellstrom K, Lindmark B, Wahlberg B, Fugl-Meyer AR. Self-efficacy in relation to impairments and activities of daily living disability in elderly patients with stroke: a prospective investigation. J Rehabil Med. 2003 Sep;35(5):202-7. doi: 10.1080/16501970310000836.

  • Arkkukangas M, Baathe KS, Ekholm A, Tonkonogi M. A 10-week judo-based exercise programme improves physical functions such as balance, strength and falling techniques in working age adults. BMC Public Health. 2021 Apr 17;21(1):744. doi: 10.1186/s12889-021-10775-z.

Related Links

Study Officials

  • Michail Tonkonogi, PhD

    Dalarna University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: An intervention group which will be training the 10-week judo4 balance
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Medical Science

Study Record Dates

First Submitted

March 1, 2020

First Posted

March 4, 2020

Study Start

May 1, 2018

Primary Completion

February 1, 2020

Study Completion

December 31, 2020

Last Updated

July 13, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

We are currently investigating with regard to the newly introduced GDPR (data integrity) laws within the European Union which individual data that decoded could be possible to share with other researchers and in what format. However, the extended test protocols for adults as well as newly developed test protocols which could have significant impact on improving the research among more physically adept adults with regards to the risk of falls and fall injury could be released for the common good of improving and enhancing the research in this field within 6 months - 1 year after the first publication.

Locations