Frailty Clinical Trial
— J4BEOfficial title:
Impact of Skills Acquired Through Judo Training on Risk Factors for Falling in Elderly Men and Women
Verified date | July 2022 |
Source | Dalarna University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | January 31, 2022 |
Est. primary completion date | January 21, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 55 Years to 110 Years |
Eligibility | Inclusion Criteria: - 55 - 110 years of age - Understanding oral and written communication in Swedish Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Dalarna University | Falun | Dalarna |
Lead Sponsor | Collaborator |
---|---|
Dalarna University | Sormland County Council, Sweden, The Swedish Judo Federation |
Sweden,
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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.
Frändin K, Grimby G. Assessment of physical activity, fitness and performance in 76-year-olds. Scand J Med Sci Sports. 1994; 4(1), 41
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. — 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
Hellström 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.
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in movement patterns when having fear of falling | Optional on some of the subjects.
The participant's pattern of movement will be analyzed before, and after the intervention with the help of "surface-Electromyography (EMG) electrodes place bilaterally on the back muscles and accelerometer based mobility sensors placed on the participants's wrists, ankles and chest. |
Before and after 12 weeks | |
Primary | 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. |
Before and after 12 weeks | |
Primary | 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. | Before and after 12 weeks of training (+addition after 7 months of self quarantine) | |
Secondary | 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. | Before and after 12 weeks | |
Secondary | 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. | Before and after 12 weeks | |
Secondary | 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. | Before and after 12 weeks (+addition after 7 months of self quarantine after Covid pandemic) | |
Secondary | 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. | Before and after 12 weeks (+addition after 7 months of self quarantine during Covid pandemic) | |
Secondary | Identification of depressive symptoms after quarantine the last 2 weeks | WHO 5 | (addition after 7 months of self quarantine) |
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