Aging ProblemsJ4BENCT04061785
Impact of Skills Acquired Through Judo Training on Risk Factors for Falling in Elderly Men and Women
A study testing Judo4Balance - 12 week judo inspired exercise program in people with Aging Problems and Frailty, run by Dalarna University at 1 site in Sweden.
Trial summary
Falls and injuries from falls are one of the greatest threats to public health. One of the risk factors for accidental falls is a low self-efficacy regarding the perceived capability to perform activities without the risk of falling. Read more about this study
- Who is it for?
- Ages 55 to 110 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging Problems, Frailty, Fall Injury
- What is being tested?
- Judo4Balance - 12 week judo inspired exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 30 Sep 2019to 31 Jan 2022
- 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 55 to 110 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 55 - 110 years of age
- Understanding oral and written communication in Swedish
Who cannot join
- Cannot sit up without support
- Not being able to hold up neck when laying on the floor or rolling backwards.
- Aortic aneurysm,
- Angina pectoris
- Cataract operation within the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Falls and injuries from falls are one of the greatest threats to public health. One of the risk factors for accidental falls is a low self-efficacy regarding the perceived capability to perform activities without the risk of falling. Judo is a sport which include "break fall" strategies where falls with correct landing strategies and rolling movements are in focus in order to avoid injuries. The investigators expect that a judo inspired training (Judo4Balance) will strengthen self-efficacy when it comes to the perceived ability to perform daily tasks without the risk of falling and thereby reduce the risk for falling. Judo based training also includes a well rounded training with focus on strength, balance, explosive power, stamina, proprioception and flexibility. These physical qualities are of importance for reducing the risk of falling. Therefore the investigators' hypothesis is that a 12 week long judo inspired training program could be a suitable tool for reducing falls.
The aim of the project is to evaluate and document whether a 12 week standardized judo inspired exercise program including both the training of above mentioned physical qualities as well as "break fall" techniques can influence the risk of falling as well as reduce the negative consequences such as injuries from an accidental fall.
Read more
For the evaluation of the 12 week intervention a validated test battery will be used which gives an indication of the risk for falling in the near future. Furthermore, a specifically designed "Falling Competence" Test has been developed by the investigators' M. Tonoknogi and K Strömqvist Bååthe to measure "break fall" technique.
If it can be proven that the intervention group reaches the expected positive results then the control group will be offered the same type of Judo4Balance training after that they have been participating as a randomized control group.
There is evidence that the risk of falling can be reduced by training, nevertheless judo based training has not to the investigator's knowledge been scientifically investigated among the elderly with the aim of reducing the risk of falls. Neither has it been studied if this type of group training is motivational for continuing physical activity after the intervention.
Due to the Covid-19 pandemic and the Swedish Govt. recommendations (in mid March 2020) to avoid group exercises for older adults (to decrease the risk of the spread of Covid-19) the 9 exercise intervention groups where put on hold/paused after 6-9 weeks into the exercise program.
We applied for and received an approval for an addition to the ethical approval (2019-03048), in order to follow up with the study subject after 6-7 months of self-quarantine in the homes with a self rating of: Fall EfficacyScale (FES), EQ3D as well as questionnaire about the subjects perceived physical and mental health. These questionnaires were sent by post.
Read the detailed description
The aim of this study is to evaluate and document whether a 12 week standardized judo based exercise program which include both the physical as well as "break fall" technique can influence the risk of falling as well as reduce the negative consequences of an accidental fall.
Questions asked:
- Can a 12 week standardized judo based exercise program improve the physical status with regard to risks for falls among elderly ?
- Can a 12 week standardized judo based exercise program improve the balance among elderly.
- Can a 12 week standardized judo based exercise program improve the self-efficacy among elderly so they can perform their daily chores without the fear of falling
- Can a 12 week standardized judo based exercise program increase the level of physical activity among elderly?
- Can a 12 week standardized judo based exercise program decrease the risk of falls among elderly?
- Is there a difference between men and women regarding the effects on fall rate and on physical factors influencing fall injuries after the completed sixteen week standardized judo based training program
The intervention study is conducted in cooperation with the Swedish Judo Federation who has developed as standardized exercise program for the elderly named Judo4Balance. The recommended training is well in accordance with the physical exercises that are intrinsic to a judo practice. Therefore the hypothesis is that a 12 week long judo inspired training program could be a suitable tool for reducing falls and injuries from falls.
For the evaluation of the 12 week intervention a validated test battery which gives an indication of the risk of falling for an individual in the near future will be used. There will also be a specifically designed Falling Competence test to measure the effectiveness of the "break fall" training.
Furthermore a follow up of the participants' physical status and break fall technique as well as their level of physical activity will be conducted with the same set of tests two years after the first intervention.
The persons included in the study will where it is possible be followed up regarding fall incidents for several years.
If it can be proven that the intervention group reaches the expected positive results such as improved physical status, higher self-efficacy with regards to falling and increased technical "break fall" skills then the control group will be offered the same type of Judo4Balance training one or two terms after that they have been participating as a randomized control group.
There is evidence that the risk of falling can be reduced by training, nevertheless judo based training has not to the investigators's knowledge been scientifically investigated among the elderly with the aim of reducing the risk of falls. Neither has it been studied if this type of group training is motivational for continuing physical activity after the intervention.
A randomized control study consisting of an intervention study and a control group that is carried out between 2019 - 2022 at different places throughout Sweden.
Recruitment will be made at local health centers, judo clubs, and through cooperation with clubs and activity centers for retired people.
Older adults interested in the intervention will be informed about the study both in written form and verbally and are signing a consent form. Independent research assistants perform the tests. After the tests are made the participants in the study will be randomized into one of two groups. One group will participate in the standardized judo inspired 12 week practice and one group will not participate. Practical tests and questionnaires are repeated again after the 12 weeks regardless of group affiliation.
The judo based exercise program (Judo4Balance)is divided into three blocks and is lead by experienced and especially trained judo teachers during 12 - 16 weeks (12 -16 sessions)
Block 1) Good technique during break fall training and strength training, accustom 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 that are not used during daily living activities such as getting down and up from the floor, flexibility training för stiff joints such as neck, upper back and shoulders.
Block 2) Improve "break fall" technique and strength exercises, increase the load in the strength exercises, challenge the balance and coordination, increase the range of motion, introduce "power" exercises when the participants master the technique, continue to build up the load resistance in muscles, tendons, and bones.
Block 3) Train the skill of explosive power during strength exercises and break falls. Challenge the balance with increased complexity and difficulty.
Before the intervention and after the 12 week of standardized judo training program and for the control group no specific program given the following tests will be made:
The participants fill in a health declaration and a questionnaire that besides demographic information also includes questions about motivation through two questions regarding readiness for change and self-efficacy regarding performing daily tasks without fear of falling.
Modified Falls-Efficacy Scale - Swedish version (FES(S)) is a validated questionnaire which measures the self confidence in performing an activity without falling on an 11 grade scale, where 0 is not sure at all and 10 is totally confident when performing the activity without falling. The participant rates oneself based on 13 described activities where maximum score is 130 points.
The physical status with relevance to fall risk will be evaluated using the modified Short Physical Performance Battery (SPPB) where each physical function, balance, strength and walking is evaluated on a 4 grade scale. The test has a max points of 12 and has proven to have a good reliability according to test - retest.
The Mini-Balance Evaluation System Test (Mini-BESTest) is used to measure balance. The test includes 14 different tasks on 4 sub-scales. All tasks are graded from 0 to 2 points, with a total maximum score of 28 points. The test has high reported test-retest reliability and inter rater reliability.
Since there are no previously known tests for the evaluation of judo "break fall" techniques for adults or elderly people, two tests have been designed by Professor M. Tonkonogi \& Research Assistant K. Strömqvist Bååthe at Dalarna University in cooperation with The Swedish Judo Federation to test the acquired skills for falling backwards as well as falling forwards in a safe setting, with progressive difficulty. The judo fall techniques are graded on a 0-4 scale. Where 0 represents the minimum score and 4 the maximum score. Four judo puzzle mats are needed for the exercises.
Frändin/Grimby Activity Scale will be used to measure the level of physical activity. 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 scale has been evaluated and shown to have good validity.
European Quality of Life Questionnaire (EQ-5D or EQ3D) will be used to measure quality of life in five dimensions, hygiene, main activities, pain, worry and mood/depression. Furthermore an evaluation of the participant's health status is made on a vertical analogue scale (VAS) graded 0-100. EQ-5D is proven to have a good test-retest reliability and a high validity.
The pattern of movement will be analyzed before, and after the intervention with the help of "surface - electromyograph electrodes placed bilaterally on the participant's back muscles and accelerometer based mobility sensors placed on the perons's wrists, ankles and chest.
Change over time will be calculated with paired non-parametric statistics for nominal and original data. Change over time for interval and quote data is calculated with parametric statistics. Uni-variate data and multivariate data analysis will be used for calculating change and outcome variables between the groups over time A p-Value <0.05 is needed to show a significant difference.
The study had to be temporarily suspended because of the Covid pandemic after 6-9 sessions. However, in the fall of 2021 we were able to restart the training with both the exercise group as well as the control group. Both groups trained for 12 weeks. The test battery was performed both before and after the 12 week intervention.
- Conditions
- Aging Problems, Frailty, Fall Injury, Accidental Fall, Fear of Falling
- Being tested
- Judo4Balance - 12 week judo inspired exercise program
- Keywords
- Fall prevention, Physical training, judo, exercise, Judo4Balance, Break falls, Preventive Exercise
- Medical subject headings
- Frailty, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Judo4Balance - 12 week judo inspired exercise programOther
12 weeks x 45 minute judo inspired exercise in lead by instructor in a group setting.
| Study group | Role | What they receive |
|---|---|---|
| Participants in 12 week Judo Inspired Exercise program | Active comparator | The subjects will participate in a 12 week judo inspired training program (45 minute sessions once a week) with the specific aim to increase physical qualities related to falls and injuries during falls.
The subjects will be tested before and after the 12 week period Receives: Other: Judo4Balance - 12 week judo inspired exercise program |
| Control Group | No intervention | The subjects will go about their normal life for 12 weeks without any intervention. The persons will be tested before and after the 12 week period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in "break fall" competence/skills
Two tests by the name "Judo4Balance - Falling Competence Test" - Backward and forward have been developed to test skills for falling backwards as well as falling forwards in a safe setting, with progressive difficulty. The judo "break-fall technique is graded on a 0-4 scale where 0 represents the minimum score and 4 represents the maximum score for each test .
Minimum Score = 0 = The subject is unable to lay down on the mat and lift the head from the surface and then stand up independently.
Maximum Score = 4 = the subejct is able to fall backwards or forwards from a standing up position without any dangerous maneuver
- A dangerous maneuver is an action which could during a fall increase the risk of injury such as: not holding up the head, not lowering the center of gravity, putting out hand or elbow etc. If a dangerous maneuver is spotted the test will be stopped.
Measured: Before and after 12 weeks
Change in Participants' Falls Efficacy after 12 weeks
The change in participants' falls-efficacy will be measured through - Modified Falls-Efficacy Scale - Swedish version (FES(S))A validated questionnaire which measures the self confidence in performing an activity without falling on an 11 grade scale, where 0 is not sure at all and 10 is totally confident when performing the activity without falling.The subject rates oneself based on 13 described activities where maximum score is 130 points.
Measured: Before and after 12 weeks of training (+addition after 7 months of self quarantine)
Secondary outcomes (5)
Change in Physical Function, Balance, Strength and Walking
This outcome will be measured through: Short Physical Performance Battery (SPPB)A test where each physical function, balance, strength and walking is evaluated on a 4 grade scale. The test has a max points of 12 and has proven to have a good test-retest reliability.
Measured: Before and after 12 weeks
Change in Balance
The Mini-Balance Evaluation Test (Mini-BEST)- Is a test used to measure balance. The test includes 14 different tasks on 4 subscales. All tasks are graded from 0 to 2 points, with a total maximum score of 28 points. The test has high reported test-retest reliability and interrater reliability.
Measured: Before and after 12 weeks
Change in level of Physical Activity
Frändin/Grimby Activity Scale will be used to measure the level of physical activity. 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 scale has been evaluated and shown to have good validity.
Measured: Before and after 12 weeks (+addition after 7 months of self quarantine after Covid pandemic)
Change in Quality of Life
European quality of life questionnaire (EQ-3D) will be used to measure quality of life in five dimensions, hygiene, main activities, pain, worry and mood/depression. Furthermore an evaluation of the persons health status is made on a vertical analogue s (VAS) graded 0-100. EQ-5D is proven to have a good test-retest reliability and a high validity.
Measured: Before and after 12 weeks (+addition after 7 months of self quarantine during Covid pandemic)
Identification of depressive symptoms after quarantine the last 2 weeks
WHO 5
Measured: (addition after 7 months of self quarantine)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start30 Sep 2019
- Primary completion21 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Aging ProblemsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalarna University
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Judo Federation, Sormland County Council, Sweden
- Responsible party
- Principal investigator, Michail Tonkonogi, Dalarna University
- Investigators
- Michail Tonkonogi, PhD, Principal investigator, Dalarna University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04061785
- Sponsor's protocol ID
- J4B190723
- Acronym
- J4BE
- Status last verified
- Jul 2022
- First submitted
- 14 Aug 2019
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 28472065Hellström K, Sandström M, Heideken Wågert P, et al. Fall-Related Self-efficacy in Instrumental Activities of Daily Living is Associated with Falls in Older Community-Living People. Phys Occup Ther Geriatr. 2013;31(2):128-139.
Franchini, E, Kiss, MA, Sterkowicz S. Physical fitness and anthropometrical differences between elite and non elite judo players. Biol Sport 2005; 22: 315-328, 2005.
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 8126356Frändin K, Grimby G. Assessment of physical activity, fitness and performance in 76-year-olds. Scand J Med Sci Sports. 1994; 4(1), 41
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 14582550Franchignoni 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 20461334Arkkukangas M, Stromqvist Baathe K, Ekholm A, Tonkonogi M. Short Multicomponent Group Exercise Intervention Promotes Long-Term Physical Activity Habits among Community-Dwelling Older Adults during COVID-19 Restrictions: A Cohort Study. Int J Environ Res Public Health. 2022 Nov 17;19(22):15140. doi: 10.3390/ijerph192215140.
PubMed 36429859
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Skills Acquired Through Judo Training on Risk Factors for Falling in Elderly Men and Women
- ClinicalTrials.gov ID
- NCT04061785
- Acronym / sponsor ID
- J4BE / J4B190723
- Conditions
- Aging Problems, Frailty, Fall Injury, Accidental Fall, Fear of Falling
- Keywords
- Fall prevention, Physical training, judo, exercise, Judo4Balance, Break falls, Preventive Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Dalarna UniversityUniversity, hospital or other
- Collaborators
- The Swedish Judo Federation, Sormland County Council, Sweden
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 21 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 20 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Falls and injuries from falls are one of the greatest threats to public health. One of the risk factors for accidental falls is a low self-efficacy regarding the perceived capability to perform activities without the risk of falling. Judo is a sport which include "break fall" strategies where falls with correct landing strategies and rolling movements are in focus in order to avoid injuries. The investigators expect that a judo inspired training (Judo4Balance) will strengthen self-efficacy when it comes to the perceived ability to perform daily tasks without the risk of falling and thereby reduce the risk for falling. Judo based training also includes a well rounded training with focus on strength, balance, explosive power, stamina, proprioception and flexibility. These physical qualities are of importance for reducing the risk of falling. Therefore the investigators' hypothesis is that a 12 week long judo inspired training program could be a suitable tool for reducing falls.
The aim of the project is to evaluate and document whether a 12 week standardized judo inspired exercise program including both the training of above mentioned physical qualities as well as "break fall" techniques can influence the risk of falling as well as reduce the negative consequences such as injuries from an accidental fall.
For the evaluation of the 12 week intervention a validated test battery will be used which gives an indication of the risk for falling in the near future. Furthermore, a specifically designed "Falling Competence" Test has been developed by the investigators' M. Tonoknogi and K Strömqvist Bååthe to measure "break fall" technique.
If it can be proven that the intervention group reaches the expected positive results then the control group will be offered the same type of Judo4Balance training after that they have been participating as a randomized control group.
There is evidence that the risk of falling can be reduced by training, nevertheless judo based training has not to the investigator's knowledge been scientifically investigated among the elderly with the aim of reducing the risk of falls. Neither has it been studied if this type of group training is motivational for continuing physical activity after the intervention.
Due to the Covid-19 pandemic and the Swedish Govt. recommendations (in mid March 2020) to avoid group exercises for older adults (to decrease the risk of the spread of Covid-19) the 9 exercise intervention groups where put on hold/paused after 6-9 weeks into the exercise program.
We applied for and received an approval for an addition to the ethical approval (2019-03048), in order to follow up with the study subject after 6-7 months of self-quarantine in the homes with a self rating of: Fall EfficacyScale (FES), EQ3D as well as questionnaire about the subjects perceived physical and mental health. These questionnaires were sent by post.
Detailed description
The aim of this study is to evaluate and document whether a 12 week standardized judo based exercise program which include both the physical as well as "break fall" technique can influence the risk of falling as well as reduce the negative consequences of an accidental fall.
Questions asked:
- Can a 12 week standardized judo based exercise program improve the physical status with regard to risks for falls among elderly ?
- Can a 12 week standardized judo based exercise program improve the balance among elderly.
- Can a 12 week standardized judo based exercise program improve the self-efficacy among elderly so they can perform their daily chores without the fear of falling
- Can a 12 week standardized judo based exercise program increase the level of physical activity among elderly?
- Can a 12 week standardized judo based exercise program decrease the risk of falls among elderly?
- Is there a difference between men and women regarding the effects on fall rate and on physical factors influencing fall injuries after the completed sixteen week standardized judo based training program
The intervention study is conducted in cooperation with the Swedish Judo Federation who has developed as standardized exercise program for the elderly named Judo4Balance. The recommended training is well in accordance with the physical exercises that are intrinsic to a judo practice. Therefore the hypothesis is that a 12 week long judo inspired training program could be a suitable tool for reducing falls and injuries from falls.
For the evaluation of the 12 week intervention a validated test battery which gives an indication of the risk of falling for an individual in the near future will be used. There will also be a specifically designed Falling Competence test to measure the effectiveness of the "break fall" training.
Furthermore a follow up of the participants' physical status and break fall technique as well as their level of physical activity will be conducted with the same set of tests two years after the first intervention.
The persons included in the study will where it is possible be followed up regarding fall incidents for several years.
If it can be proven that the intervention group reaches the expected positive results such as improved physical status, higher self-efficacy with regards to falling and increased technical "break fall" skills then the control group will be offered the same type of Judo4Balance training one or two terms after that they have been participating as a randomized control group.
There is evidence that the risk of falling can be reduced by training, nevertheless judo based training has not to the investigators's knowledge been scientifically investigated among the elderly with the aim of reducing the risk of falls. Neither has it been studied if this type of group training is motivational for continuing physical activity after the intervention.
A randomized control study consisting of an intervention study and a control group that is carried out between 2019 - 2022 at different places throughout Sweden.
Recruitment will be made at local health centers, judo clubs, and through cooperation with clubs and activity centers for retired people.
Older adults interested in the intervention will be informed about the study both in written form and verbally and are signing a consent form. Independent research assistants perform the tests. After the tests are made the participants in the study will be randomized into one of two groups. One group will participate in the standardized judo inspired 12 week practice and one group will not participate. Practical tests and questionnaires are repeated again after the 12 weeks regardless of group affiliation.
The judo based exercise program (Judo4Balance)is divided into three blocks and is lead by experienced and especially trained judo teachers during 12 - 16 weeks (12 -16 sessions)
Block 1) Good technique during break fall training and strength training, accustom 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 that are not used during daily living activities such as getting down and up from the floor, flexibility training för stiff joints such as neck, upper back and shoulders.
Block 2) Improve "break fall" technique and strength exercises, increase the load in the strength exercises, challenge the balance and coordination, increase the range of motion, introduce "power" exercises when the participants master the technique, continue to build up the load resistance in muscles, tendons, and bones.
Block 3) Train the skill of explosive power during strength exercises and break falls. Challenge the balance with increased complexity and difficulty.
Before the intervention and after the 12 week of standardized judo training program and for the control group no specific program given the following tests will be made:
The participants fill in a health declaration and a questionnaire that besides demographic information also includes questions about motivation through two questions regarding readiness for change and self-efficacy regarding performing daily tasks without fear of falling.
Modified Falls-Efficacy Scale - Swedish version (FES(S)) is a validated questionnaire which measures the self confidence in performing an activity without falling on an 11 grade scale, where 0 is not sure at all and 10 is totally confident when performing the activity without falling. The participant rates oneself based on 13 described activities where maximum score is 130 points.
The physical status with relevance to fall risk will be evaluated using the modified Short Physical Performance Battery (SPPB) where each physical function, balance, strength and walking is evaluated on a 4 grade scale. The test has a max points of 12 and has proven to have a good reliability according to test - retest.
The Mini-Balance Evaluation System Test (Mini-BESTest) is used to measure balance. The test includes 14 different tasks on 4 sub-scales. All tasks are graded from 0 to 2 points, with a total maximum score of 28 points. The test has high reported test-retest reliability and inter rater reliability.
Since there are no previously known tests for the evaluation of judo "break fall" techniques for adults or elderly people, two tests have been designed by Professor M. Tonkonogi \& Research Assistant K. Strömqvist Bååthe at Dalarna University in cooperation with The Swedish Judo Federation to test the acquired skills for falling backwards as well as falling forwards in a safe setting, with progressive difficulty. The judo fall techniques are graded on a 0-4 scale. Where 0 represents the minimum score and 4 the maximum score. Four judo puzzle mats are needed for the exercises.
Frändin/Grimby Activity Scale will be used to measure the level of physical activity. 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 scale has been evaluated and shown to have good validity.
European Quality of Life Questionnaire (EQ-5D or EQ3D) will be used to measure quality of life in five dimensions, hygiene, main activities, pain, worry and mood/depression. Furthermore an evaluation of the participant's health status is made on a vertical analogue scale (VAS) graded 0-100. EQ-5D is proven to have a good test-retest reliability and a high validity.
The pattern of movement will be analyzed before, and after the intervention with the help of "surface - electromyograph electrodes placed bilaterally on the participant's back muscles and accelerometer based mobility sensors placed on the perons's wrists, ankles and chest.
Change over time will be calculated with paired non-parametric statistics for nominal and original data. Change over time for interval and quote data is calculated with parametric statistics. Uni-variate data and multivariate data analysis will be used for calculating change and outcome variables between the groups over time A p-Value <0.05 is needed to show a significant difference.
The study had to be temporarily suspended because of the Covid pandemic after 6-9 sessions. However, in the fall of 2021 we were able to restart the training with both the exercise group as well as the control group. Both groups trained for 12 weeks. The test battery was performed both before and after the 12 week intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants in 12 week Judo Inspired Exercise program | Active comparator | Other: Judo4Balance - 12 week judo inspired exercise programThe subjects will participate in a 12 week judo inspired training program (45 minute sessions once a week) with the specific aim to increase physical qualities related to falls and injuries during falls. The subjects will be tested before and after the 12 week period |
| Control Group | No intervention | –The subjects will go about their normal life for 12 weeks without any intervention. The persons will be tested before and after the 12 week period. |
Who may qualify
- Ages
- 55 to 110 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 55 - 110 years of age
- Understanding oral and written communication in Swedish
Key exclusion criteria (5 listed)
- Cannot sit up without support
- Not being able to hold up neck when laying on the floor or rolling backwards.
- Aortic aneurysm,
- Angina pectoris
- Cataract operation within the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Judo4Balance - 12 week judo inspired exercise program12 weeks x 45 minute judo inspired exercise in lead by instructor in a group setting. | Other | Participants in 12 week Judo Inspired Exercise program |
Primary outcome
Change in "break fall" competence/skills
Time frame: Before and after 12 weeks
Two tests by the name "Judo4Balance - Falling Competence Test" - Backward and forward have been developed to test skills for falling backwards as well as falling forwards in a safe setting, with progressive difficulty. The judo "break-fall technique is graded on a 0-4 scale where 0 represents the minimum score and 4 represents the maximum score for each test . Minimum Score = 0 = The subject is unable to lay down on the mat and lift the head from the surface and then stand up independently. Maximum Score = 4 = the subejct is able to fall backwards or forwards from a standing up position without any dangerous maneuver * A dangerous maneuver is an action which could during a fall increase the risk of injury such as: not holding up the head, not lowering the center of gravity, putting out hand or elbow etc. If a dangerous maneuver is spotted the test will be stopped.
Change in Participants' Falls Efficacy after 12 weeks
Time frame: Before and after 12 weeks of training (+addition after 7 months of self quarantine)
The change in participants' falls-efficacy will be measured through - Modified Falls-Efficacy Scale - Swedish version (FES(S))A validated questionnaire which measures the self confidence in performing an activity without falling on an 11 grade scale, where 0 is not sure at all and 10 is totally confident when performing the activity without falling.The subject rates oneself based on 13 described activities where maximum score is 130 points.
5 secondary outcomes
Change in Physical Function, Balance, Strength and Walking
Time frame: Before and after 12 weeks
Change in Balance
Time frame: Before and after 12 weeks
Change in level of Physical Activity
Time frame: Before and after 12 weeks (+addition after 7 months of self quarantine after Covid pandemic)
Change in Quality of Life
Time frame: Before and after 12 weeks (+addition after 7 months of self quarantine during Covid pandemic)
Identification of depressive symptoms after quarantine the last 2 weeks
Time frame: (addition after 7 months of self quarantine)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
- Background: PubMed 28472065Timsina 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.
- BackgroundHellström K, Sandström M, Heideken Wågert P, et al. Fall-Related Self-efficacy in Instrumental Activities of Daily Living is Associated with Falls in Older Community-Living People. Phys Occup Ther Geriatr. 2013;31(2):128-139.
- BackgroundFranchini, E, Kiss, MA, Sterkowicz S. Physical fitness and anthropometrical differences between elite and non elite judo players. Biol Sport 2005; 22: 315-328, 2005.
- Background: PubMed 8126356Guralnik 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.
- BackgroundFrändin K, Grimby G. Assessment of physical activity, fitness and performance in 76-year-olds. Scand J Med Sci Sports. 1994; 4(1), 41
- Background: PubMed 14582550Hellstrom 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.
- Background: PubMed 20461334Franchignoni 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.
- Derived from this study: PubMed 36429859Arkkukangas M, Stromqvist Baathe K, Ekholm A, Tonkonogi M. Short Multicomponent Group Exercise Intervention Promotes Long-Term Physical Activity Habits among Community-Dwelling Older Adults during COVID-19 Restrictions: A Cohort Study. Int J Environ Res Public Health. 2022 Nov 17;19(22):15140. doi: 10.3390/ijerph192215140.
- Description and film from the Swedish Judo4Balance exercise program for elderlyLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Aging Problems
Recruiting
Evaluation of the PPAL
Age Problems
Not yet recruitingObservational study
Vascular Aging and Microcirculation: Physiological Aspects of Vascular Aging in the Elderly Population (VAMP-Aging)
Aging Problems
Active, not recruiting
Promoting Goals-of-Care Discussions for Patients With Memory Problems and Their Caregivers
Dementia, Dementia, Vascular
RecruitingEarly Phase 1
Examining the Effects of Theta Burst TMS on Brain Connectivity and Balance Ability in Older Adults With Balance Problems
Aging, Balance Deficits
Active, not recruiting
Brain Health Virtual Reality Study
Aging, Aging Problems
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michail Tonkonogi, PhD principal investigator
Dalarna University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Judo4Balance - 12 week judo inspired exercise program in people with Aging Problems and Frailty, 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 2 inclusion and 5 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 "break fall" competence/skills (time frame: Before and after 12 weeks). The study lists 2 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 NCT04061785, which also lists 8 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.