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Accidental FallJ4BANCT04294342

The Impact of Specifically Adapted Judo-based Training Program on Risk Factors for Falls Among Adults

A study testing Active Comparator: Participants in 10 week Judo Inspired Exercise program in people with Accidental Fall and Fall Injury, run by Dalarna University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Accidental Fall, Fall Injury, Work-related Injury
What is being tested?
Active Comparator: Participants in 10 week Judo Inspired Exercise program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
162 participants
Where
1 siteSweden
Study dates
1 May 2018to 31 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Dalarna University

    Falun, Dalarna County, 791 88

Other trials in Sweden

About this study

Official title: Health Promotion and Prevention: The Impact of Specifically Adapted Judo-based Training Program on Risk Factors for Falls Among Adults at Work

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.

Read the detailed description

The aim of this study is to evaluate and document whether a ten week standardized judo inspired exercise program (Judo4Balance) which include both training the physical qualities such as strength and balance as well as the "break fall" technique can influence the risk of falling as well as reduce the negative consequences of an accidental fall.

Questions asked:

  • Can a ten week standardized judo based exercise program improve the "break fall" competence among adults ?
  • Can a ten week standardized judo based exercise program improve the fall-efficacy at home and at work among adults ?
  • Can a ten week standardized judo based exercise program improve the physical status with regards to the risks for falls among adults ?
  • Can a ten week standardized judo based exercise program improve the balance among adults ?
  • Could a ten week standardized judo based exercise program be a useful tool in an organisation's preventive Health and Safety work.

The study included two groups with ethical approval to recruit up to 100 individuals in the intervention group and up to 100 individuals in a control group. (control participants are selected mainly the same workplace where the group exercises are being performed and consists of a similar sample of age, sex and physical status ).

The study is conducted in accordance with the Declaration of Helsinki. This study was approved by the Ethical Committee of the Uppsala Region (Dnr 2018/239). Each participant voluntarily provided a written informed consent before participating. Participants were informed that they could withdraw from participation at any time for any reason without any consequences. The participants received no compensation for participating in the study.

A total of seven different workplaces from different parts of Sweden participate in the study of the judo-inspired exercise program (construction and steel industry, healthcare, pre-school, insurance office, advertising, and health and safety consultants). Judo Clubs from different locations in Sweden as well as an insurance company offered the program as part of their preventive Health and Safety at the workplace program. Workplaces report an interest in participating and view their participation as part of their systematic work to promote Health and Safety among employees. Information and an invitation to participate in the 10-week program were provided to employees at the workplace setting.

After an acceptance to participate, written consent is obtained. Measurements were performed at the workplace by a qualified judo instructor.

A total of three qualified Judo instructors, familiar with the physical tests performed the pre- and post-assessments. A total of 14 qualified judo instructors provide instructions in the different groups (on average, 2 instructors per group of 10-18 persons). The instructors teaching the special exercise program are required to have at least a blue belt in judo (which means a minimum of 5 years of regular judo and break fall training). All the instructors teaching the classes in the study have black belts. To teach the program, there are also a requirement to have a coaching license from the Swedish Judo Federation and to have undergone a specific weekend course in the Judo4Balance program, with a focus on teaching judo-related exercises and fall techniques to adult beginners.

The program is delivered in a 45-50-minute session once a week for ten weeks at the respective workplace or other suitable location for the group exercise. The 10 week program is divided into three blocks and taught by experienced and especially trained judo instructors.

Block 1: Good technique during break fall training and strength training, accustomed the body to regular training, find the right level of training for the group, build up load resistance in muscles, tendons and bones. Challenge the balance through new movements not used everyday. Flexibility training for stiff joints such as neck and upper back.

Block 2: Improve "break fall" technique and strength exercises, increase the loads and further challenge the balance and coordination, increase range of motion and introduce "power training".

Block 3: Train the skill of explosive power during strength exercises and break falls. Challenge the balance with increased complexity and difficulty.

The participants both in the intervention group and control group are tested before and after the 10 week period. After the tests have been carried out a questionnaire is to be sent out to the instructors to get their evaluation of the suitability and effectiveness of the program at the work place. A similar questionnaire will be sent out to the participants to evaluate their experience of this preventive program from a Health and Safety at work perspective.

There is strong evidence that exercise can reduce the risk of falling. Nevertheless, judo based training has not to the investigators knowledge been scientifically investigated for working adults with the aim of reducing falls at the workplace and elsewhere. Neither has it been studied if this type of group training is motivational for continuing physical activity after the intervention or for improving the health and safety among employees.

Being tested
Active Comparator: Participants in 10 week Judo Inspired Exercise program
Keywords
Fall prevention, Physical training, judo, judo4Balance, Break falls, Health and Safety, Falling at work

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active Comparator: Participants in 10 week Judo Inspired Exercise programBehavioural

    Also called Judo4Balance: Fall-Preventive Exercise Group

    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.

Study groups in NCT04294342
Study groupRoleWhat they receive
Participants in 10 week Judo Inspired Exercise programActive comparatorThe 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.
Receives: Behavioral: Active Comparator: Participants in 10 week Judo Inspired Exercise program
Control GroupNo interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Before and after 10 weeks of training

  2. 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.

    Measured: Before and after 10 weeks of training

  3. 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.

    Measured: Before and after the 10 weeks of training

Secondary outcomes (4)
  1. 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.

    Measured: Before and after 10 weeks of training

  2. 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.

    Measured: Before and after 10 weeks training

  3. 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.

    Measured: After the 10 weeks of training

  4. 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.

    Measured: After the 10 week program

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2020
  2. Study start1 May 2018
  3. Primary completion1 Feb 2020
  4. Study completion31 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
An intervention group which will be training the 10-week judo4 balance
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
162 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04294342
Sponsor's protocol ID
J4B180802-Fallkompetens
Acronym
J4BA
Status last verified
Jul 2022
First submitted
1 Mar 2020
Last updated
13 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 28472065
  • 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.

    PubMed 8126356
  • 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.

    PubMed 20461334
  • 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.

    PubMed 14582550
  • 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.

    PubMed 33865349

Questions about this trial

What is this clinical trial studying?

A study testing Active Comparator: Participants in 10 week Judo Inspired Exercise program in people with Accidental Fall and Fall Injury, run by Dalarna University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in participants "break fall" competence/skill (time frame: Before and after 10 weeks of training). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04294342, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2022.

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