Clinical trial NCT04294342: The Impact of Specifically Adapted Judo-based Training Program on Risk Factors for Falls Among Adults
Official title: Health Promotion and Prevention: The Impact of Specifically Adapted Judo-based Training Program on Risk Factors for Falls Among Adults at Work
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Accidental Fall
Fall Injury
Work-related Injury
Work Accident
Keywords: Fall prevention
Physical training
judo
judo4Balance
Break falls
Health and Safety
Falling at work
Lead sponsor: Dalarna University
Sponsor class: OTHER
Collaborators: name: Sormland County Council, Sweden
First posted: 2020-03-04
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An intervention group which will be training the 10-week judo4 balance
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in participants "break fall" competence/skill
timeFrame: Before and after 10 weeks of training
measure: Change in participants' fall efficacy after 10 weeks
timeFrame: Before and after 10 weeks of training
measure: Change in Balance
timeFrame: Before and after the 10 weeks of training
Secondary outcomes:
measure: Short Physical Performance Battery (SPPB-W)
timeFrame: Before and after 10 weeks of training
measure: Change in level of Physical Activity
timeFrame: Before and after 10 weeks training
measure: Judo4Balance Instructors perception of the suitability and effectiveness of the program
timeFrame: After the 10 weeks of training
measure: Judo4Balance - Participant Survey
timeFrame: After the 10 week program
Other outcomes:
Locations:
city: Falun
country: Sweden
facility: Dalarna University
state: Dalarna
Study officials:
affiliation: Dalarna University
name: Michail Tonkonogi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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/journal.pone.0176561. eCollection 2017.
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 admission. J Gerontol. 1994 Mar;49(2):M85-94. doi: 10.1093/geronj/49.2.m85.
citation: 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.
citation: 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.
citation: 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.