NCT04061785

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 20, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

September 30, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2022

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

July 13, 2022

Status Verified

July 1, 2022

Enrollment Period

2.3 years

First QC Date

August 14, 2019

Last Update Submit

July 11, 2022

Conditions

Keywords

Fall preventionPhysical trainingjudoexerciseJudo4BalanceBreak fallsPreventive Exercise

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (5)

  • Change in Physical Function, Balance, Strength and Walking

    Before and after 12 weeks

  • Change in Balance

    Before and after 12 weeks

  • Change in level of Physical Activity

    Before and after 12 weeks (+addition after 7 months of self quarantine after Covid pandemic)

  • Change in Quality of Life

    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

    (addition after 7 months of self quarantine)

Other Outcomes (1)

  • Change in movement patterns when having fear of falling

    Before and after 12 weeks

Study Arms (2)

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

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.

Interventions

12 weeks x 45 minute judo inspired exercise in lead by instructor in a group setting.

Participants in 12 week Judo Inspired Exercise program

Eligibility Criteria

Age55 Years - 110 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • Understanding oral and written communication in Swedish

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dalarna University

Falun, Dalarna County, SE-79188, Sweden

Location

Related Publications (8)

  • 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.

    PMID: 28472065BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 8126356BACKGROUND
  • Frändin K, Grimby G. Assessment of physical activity, fitness and performance in 76-year-olds. Scand J Med Sci Sports. 1994; 4(1), 41

    BACKGROUND
  • 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.

    PMID: 14582550BACKGROUND
  • 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.

    PMID: 20461334BACKGROUND
  • Arkkukangas 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.

Related Links

MeSH Terms

Conditions

FrailtyMotor Activity

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Michail Tonkonogi, PhD

    Dalarna University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 14, 2019

First Posted

August 20, 2019

Study Start

September 30, 2019

Primary Completion

January 21, 2022

Study Completion

January 31, 2022

Last Updated

July 13, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations