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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04294342
Other study ID # J4B180802-Fallkompetens
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2018
Est. completion date December 31, 2020

Study information

Verified date July 2022
Source Dalarna University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Intervention

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

Locations

Country Name City State
Sweden Dalarna University Falun Dalarna

Sponsors (2)

Lead Sponsor Collaborator
Dalarna University Sormland County Council, Sweden

Country where clinical trial is conducted

Sweden, 

References & Publications (4)

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. — View Citation

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 — View Citation

Hellström 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. — View Citation

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/jo — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 Short Physical Performance Battery (SPPB-W) Short Physical Performance Battery (SPPB) is used to assess the physical performance in the lower extremities, which was expanded with an additional difficulty progression to suit people of working age (W). The additional progression included advanced items in each of the three components: balance (tandem with heel raise, and tandem with heel raise with closed eyes), gait speed (backwards), and lower body power (chair stand on one leg -left/right). The original scale scores range from 0 to 4 for three components, with an additional score of 20 for the additional items. A total score of 12 represents the best performance for the original test and 32 the best score for the expanded test. The original SPPB has shown to predict the risk of falls in adults over the age of 60. The test has shown to have good test-retest reliability and being sensitive to changes. Before and after 10 weeks of training
Secondary Change in level of Physical Activity Frändin/Grimby Activity Scale is used to measure the level of physical activity. Three different questions are used capturing activity levels during summer, winter, and at the workplace. The scales range from 1 to 6, with 1 representing 'hardly active at all' and 6 representing 'intensive exercise regularly and several times per week.' The original scale has been evaluated and shown to have good validity. Before and after 10 weeks training
Secondary Judo4Balance Instructors perception of the suitability and effectiveness of the program A questionnaire will be sent out to the instructors to capture their view the exercise program and its effects on the participants and the workplace environment from a workplace practical and Health and Safety perspective. The initial three questions are graded on a scale from 1-10 where 5 represents "meets expecations" and 1 "not at all meet expectations" and 10 " highly exceeds expectations. The last questions are open questions. After the 10 weeks of training
Secondary Judo4Balance - Participant Survey An anonymous survey will be sent out to the participants (after training and testing is finished) to catch their perception of the program from a work place "Health and Safety" perspective. Indicators such as: met expectations, team building, continued interest in exercising and joy at the workplace will be asked. The initial questions are graded on a scale from 1-10 where 5 represents "meet expectations or agree" and 1 "not at all meet or agree" and 10 represents "highly exceeds expectations". There are also some open questions. After the 10 week program
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