Fall PreventionNCT04759690
Effects of Action Observation Training and Exercises Over 65 Years Old
A study testing Action observation and Exercise group in people with Fall Prevention and Elderly, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
With aging, the decrease in muscle strength in the musculoskeletal system , body biomechanics and posture changes and the risk of falling increase. The greatest danger of falling in this population is risky and the other danger is that it causes fractures, creates physical and psychological trauma, and increases the… Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Fall Prevention, Elderly
- What is being tested?
- Action observation and Exercise group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Dec 2020to 31 May 2021
- 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 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Those who volunteered to participate in the study and between the ages of 65 and 80
- Who scored 24 or more out of 30 points in the Standardized Mini-Mental Test (SMMT)
- Non-neurological or orthopedic problems
- Had vision and hearing problems at a level that would prevent participation in the study.
Who cannot join
- Those who have any neurological, internal or orthopedic problems that may affect the balance,
- Those with unstable hypertension and diabetes,
- Those with a diagnosis of Chronic Obstructive Pulmonary Disease (COPD),
- Those who have had a surgical procedure that may affect the balance in the last 6 months were excluded from the study.
- Wheelchair dependents
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University Kavacık Campus
Istanbul, Kavacık, 34810
About this study
Official title: Effects of Action Observation Training Combined With Exercises on Balance and Risk of Fall Over 65 Years Old
With aging, the decrease in muscle strength in the musculoskeletal system , body biomechanics and posture changes and the risk of falling increase. The greatest danger of falling in this population is risky and the other danger is that it causes fractures, creates physical and psychological trauma, and increases the need for long-term care and health services. Increasing exercise efficiency for balance and preventing falls are extremely important for physical and cognitive health.
İn recent years ,the''Action Observation''approach has been used as an added method to treatments to increase the effectiveness of exercise.Action observation ; it is a cognitive training that triggers motor learning by observing the desired activity and positively affects learning.
Read more
The aim of the study : To investigate the effects of exercises on balance and fall risk together with action observation in individuals over 65 years of age . The researchers planned to combine action observation and traditional balance exercises as a group training and compare them with the control group .
The hypothesis of the research is that action observation(AO) will be more useful in maintaining balance and preventing the risk of falling.
Materials and methods of the research:Participants will consist of volunteers over 65 years of age(65-80 years old ). 60 participants to be selected randomly. The participants will be randomly assigned 2 groups.
Experimental group :( 30 participants ) Action observation+ exercise combination Control group :( 30 participants ) will only exercise Study protocol:The randomized experimental and control group will study 3 days per week for a total of 8 weeks .Exercises difficulty;Borg Scale(0-10):It will be modarate.
Evaluation:All evaluations will be made as a Pre-test/Post-test. The detailed descriptions and characteristics of the participants will be summarized at baseline and after 8 weeks, and the differences between groups, intergroup differences will be statistically evaluated.
Read the detailed description
Purpose of the research:To investigate the effects of exercises combined with action observation on balance and fall risk in individuals over 65 years of age.
The hypothesis of the research is that action observation will be more useful in maintaining balance and preventing the risk of failling.
Action observation therapy (AOT)is a novel rehabilitation technique, which involves observation of purposeful actions with the intention to imitate and then performing those actions. AOT can be described as the patient being asked to carefully observe actions presented through a video-clip or performed by an operator, in order to imitate, try, and execute them after observation .This may include the mirror neuron system (MNS) processes on the upper limb function resulting from the observation of actions (new motor skills) and actual execution of similar neural structures . Current evidence have been limited to investigating AOT effectiveness on upper and lower limb rehabilitation in both neurological and orthopedic disorders, patients with stroke and brain injuries, limb pain, Parkinson disease, and in the old women. However, despite the volume of our understanding, there is a dearth of current scientific evidence evaluating the efficacy of AOT combined with exercises on balance and risk of fall in elderly both in men and women.
Study Power Analysis:The effect size was calculated using the G Power Package Program(G Power 3.0.10) over the data of the reference article(Leem SH et al,2019).The sample size required for the study according to the calculated effect size was determined as at least 38 participants for %95 power and Type I error rate (alpha):0.05 were calculated.To increase the power of our study, we invited 100 volunteer participants and after the exclusion criteria, we started with 60 participants, but with 43 participants.We were able to complete our work.
Our research is a randomized, controlled experimental study that examines the effect of Action Observation Therapy (EGT) on balance and fall risk in individuals over the age of 65, with a probabilistic, systematic sample.
Study protocol:
Participants will be randomly divided into two groups as experimental and control groups.
Experimental group participants:(n=30) Action observation+ exercise combination Control group participants:(n=30) Only exercise A total of 43 participants completed the study as 22 participants in the experimental group and 21 participants in the control group for various reasons.
Experimental group , the participants will be asked to carefully observe actions presented through a video-clip exercise for 15 minutes, and then do same exercises for about 45 minutes in 5-10 repetitions.
The Control group (only exercise group), the participants will perform exercises for about 45 minutes in 5-10 repetitions without a video-clip observation.
Study program:3 days a week for 8 weeks Exercise difficulty:Modified Borg Scale(0-10); The modified Borg Scale was used to evaluate the intensity and difficulty grades of the exercises . Initially, the scores of 3 and 4 were applied, and a gradual increase up to 5 and 6 at the end of the studyExercise program:Exercises will be easy to learn but not complex in terms of recall and performans. Depending on the fitness of the person, %50-75 of the maximum heart rate (220-years),the exercise intensity will be preferred over the Borg Scale.
The center where the research will be conducted ,İstanbul-Beşiktaş District Abbasağa neighborhood.
Exercises;sitting and standing from easy to difficult; it will be advanced from those done with two feed touching the ground to those done on one foot and walking. It will include warm-up period, strengthening exercises ,static and dynamic balance exercises, flexibility exercises and cooling periods. The exercises were repeated 5 times initially. Then their repetition numbers were gradually increased up to 8-10 repetitions in small groups of 5-7 people.All AOT and exercise programs were performed in the Abbasağa garden park, a quiet place without noise. We obtained local permission from Besiktas Municipality, Istanbul, Turkey, and applied the general rules for the COVID-19 pandemic.The participant registration and acceptance of this study and the implementation of the exercises protocol were made by the same research physical therapist.
Study start date: December-2020
Study application date: 1 April / 31 May 2021
Completion of research: December-2021
Evaluation: All evaluations will be made as a Pre-test/ Post-test The detailed descriptions and characteristics of the participants will be summarized at baseline and after 8 weeks, and the differences between groups, intergroup differences will be statistically evaluated.
Socio-demographic evaluation Blood pressure and heart rate measurement Mini-Mental Test İnternational Physical Activity Questionnaire Short Form(IPAQ-Short)
Cognitive Level Tests :
Montreal Cognitive Assessment(MoCA)
Balance and Fall Risk Tests:
Time Up\&Go Test(TUG) 5 Times Sit \& Stand Test Tinetti Balance and Walk Test Activity Specific Balance Confidence Scale(ABC) BORG Scale (0-10): To determine exercise intensity I have prepared '' Pain Location and İntensity" and "Fall Frequency Questioning"and "Participant Satisfaction" evaluation forms in the last year.
Statistical evaluation: The evaluation of the all data will be done using the SPSS statistical package program.The data will be analyzed using the SPSS program with the significance level of p<0.05
İstanbul Medıpol Unıversıty Non-İnterventional Clinical Research Ethıcs Committee Permission of the research was obteined(Number:10840098-772.02-E.58328,Date:10/26/2020).
- Conditions
- Fall Prevention, Elderly
- Being tested
- Action observation, Exercise group
- Keywords
- Aging, Action observation, Balance exercise, Fall prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Action observationBehavioural
Also called Conventional balance exercises
Action observation group: The participants will first watch the conventional balance exercises with the action observation method on video for 15 minutes.After watching of conventional balance exercise for 45 minutes in 5-10 repetitions.
Exercise groupBehavioural
Exercise group is the control group.TheParticipants will only do the conventional balance exercise without action observation for 45 minutes in 5-10 repetitions.
| Study group | Role | What they receive |
|---|---|---|
| Action observation and exercise group | Experimental | Action observation group consist of 30 randomly selected participants.Action observation + conventional balance exercise group Receives: Behavioral: Action observation; Behavioral: Exercise group |
| Exercise group | Other | Exercise group is the control group.Consist of 30 randomly selected participants. The participants will only do the conventional balance exercise. Receives: Behavioral: Exercise group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-Mental State Examination
Mini Mental State Test is a short test used for dementia screening. It consists of ten questions. It measures orientation, memory, attention, calculation, language, motor function and perception, immediate and brief recall, language and simple verbal and written instructions as well as visual construction. The test is evaluated over 30 points. Between 24-30 points is considered normal and below 23 points is considered risk of dementia.This test is also affected by age and education level. The test used as the acceptance of the study participants to the research.
Measured: Baseline
Baseline characteristics of the participants
To interpret the results of our study, baseline characteristics of the participants including age, gender, education, marital status, height, weight will be recorded.
Measured: Baseline
Montreal Cognitive Assessment Scale
Montreal Cognitive Assessment Scale is a rapid screening test for measuring cognitive level and mild cognitive impairment.
With the Montreal Cognitive Assessment Test, 8 different cognitive functions are evaluated: attention and concentration, executive functions, memory, language, visual structuring skills, abstract thinking, calculation and orientation. The highest score that can be obtained from the test is 30. Accordingly, 21 points and above is considered normal.
Measured: Baseline to end of week 8 when the study is completed.
The International Physical Activity Questionnaire short form
The short form IPAQ is a 7-item scale, assessing the amount of minutes spent in vigorous and moderate intense activity and walking during the last 7 days. For all categories, the amount of Metabolic Equivalents (METs) minutes is calculated by multiplying the amount of minutes with 8 (vigorous), 4 (moderate), 3.3 (walking), or 1.3 (sitting).
Measured: Baseline.
Five Times Sit-to-Stand Test
The Five Times Sit and Stand Test is a clinical test that investigates postural control and lower extremity muscle strength. It is determined by measuring the time to complete the sitting-stand up activity at least five times with a stopwatch. Completion time below 12 seconds is considered a risk for recurrent falls.
Measured: Baseline to end of week 8 when the study is completed.
Tinetti Balance and Gait Scale
Tinetti's balance and gait scale is used to determine fall risk, especially in the elderly. It is a combination of two scales, one evaluating balance and gait characteristics. The full scale is calculated by summing the questions consisting of 9 items for balance and 7 items for walking, and evaluation scores such as 0-1-2. It is calculated by adding a maximum balance score of 16 points and a maximum walking score of 12 points. The total score is 28 as balance + walking. 18 points and below indicate high fall risk, 19-24 points medium fall risk, 24 points and above indicate low fall risk.
Measured: Baseline to end of week 8 when the study is completed.
Activity Specific Balance Confidence Scale
Activity Specific Balance Confidence Scale was developed by Powell and Myers. This scale includes 16 tasks related to indoor and outdoor activities of daily living to balance trust in older people with varying levels of functioning. Scores range from 0 percent (no confidence) to 100 percent (complete confidence) for each question item. Higher scores with a percentage increase indicate more confidence.
Measured: Baseline to end of week 8 when the study is completed.
Heart rate measurement
There are many circulatory changes that occur during exercise to supply the tremendous blood flow required by the muscles including the stimulatory effects on the circulation by the mass sympathetic discharge, the increased arterial pressure and cardiac output. These cardiovascular responses is important that adults, and elderly normal people due to the age related. It was preferred that the exercises should be percent of the maximum heart rate (220-age) according to the fitness level of the participant and the exercise difficulty level should be at the moderate.
Measured: Day 1
Borg Scale assessment of perceived effort
Borg Scale It is the marking of the exercise intensity, which is determined by a certain percentage of the calculation of the maximum heart rate according to the fitness level of the participant, by expressing the exercise intensity in the form with numbers 1-10.The exercise difficulty is indicated by the numbers 1 through 10, with 1 being the easiest and 10 the hardest.
Measured: Day 1
International Physical Activity Questionnaire Short Form
This is a questionnaire scale to determine the physical activity levels of the participants. This questionnaire consists of 4 parts as work, transportation, rest and sports activities. It is a 9-item scale that evaluates the amount of minutes spent for at least 10 minutes of vigorous, moderate activities and walking categories during the last 7 days. It is calculated by multiplying the minutes spent in each category by the metabolic equivalent. Under the 600 metabolic equivalents are considered inactive, 600-3000 metabolic equivalents minimum active and 3000 metabolic equivalents as active.
Measured: Baseline
The Timed Up and Go Test
In balance and fall risk assessments, the Timed Get Up and Go Test (TUGT) is a simple and very useful test.A chair and stopwatch are required for this test.The area of 3 meters in front of the chair is determined. The patient is asked to get up from the chair and walk this distance and sit down again.If an elderly individual completes this test in more than 12 seconds, there is a risk of falling
Measured: Baseline to end of week 8 when the study is completed.
Secondary outcomes (2)
The frequency of falling
The frequency of falling will be determined by self questioning
Measured: Baseline
Clinical pain location and pain intensity
In this test to determine the participant's clinical pain location and the severity of that pain. The participant is asked to mark the area of pain on the form with a human body template. Pain severity, which is also in the same form, is evaluated on a scale of 0-10 points. Zero means "no pain" and 10 means "pain as bad as possible".
Measured: Baseline to end of week 8 when the study is completed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start12 Dec 2020
- Primary completion1 Apr 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Fall PreventionStudies 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
- Model description
- Cross-sectional sampling / Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, bagdattekkus, Istanbul Medipol University Hospital
- Investigators
- Bağdat TEKKUŞ, 1, Principal investigator, Istanbul MEDİPOL University ,İnstitute of Health Sciences Kavacık Campus-İstanbul TURKEYFatma MUTLUAY, 2, Study director, Istanbul MEDİPOL University Faculty of Health Sciences Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759690
- Sponsor's protocol ID
- p3957ghb
- Status last verified
- Apr 2022
- First submitted
- 6 Dec 2020
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I can consider publishing my research as a doctoral thesis and related article.
Publications
Leem SH, Kim JH, Lee BH. Effects of Otago exercise combined with action observation training on balance and gait in the old people. J Exerc Rehabil. 2019 Dec 31;15(6):848-854. doi: 10.12965/jer.1938720.360. eCollection 2019 Dec.
PubMed 31938708Gangitano M, Mottaghy FM, Pascual-Leone A. Phase-specific modulation of cortical motor output during movement observation. Neuroreport. 2001 May 25;12(7):1489-92. doi: 10.1097/00001756-200105250-00038.
PubMed 11388435Bird ML, Hill K, Ball M, Williams AD. Effects of resistance- and flexibility-exercise interventions on balance and related measures in older adults. J Aging Phys Act. 2009 Oct;17(4):444-54. doi: 10.1123/japa.17.4.444.
PubMed 19940323Martins AC, Santos C, Silva C, Baltazar D, Moreira J, Tavares N. Does modified Otago Exercise Program improves balance in older people? A systematic review. Prev Med Rep. 2018 Jul 10;11:231-239. doi: 10.1016/j.pmedr.2018.06.015. eCollection 2018 Sep.
PubMed 30210995Tettamanti A, Paci E, Pelachin M, Cattrysse E, Kerckhofs E, Gatti R. Effevt of action observation training on balance performance in healthy subjects.www.physiotherapyjournal 2015:101(1);1502.
Hirvensalo M, Heikkinen E, Lintunen T, Rantanen T. Recommendations for and warnings against physical activity given to older people by health care professionals. Prev Med. 2005 Jul;41(1):342-7. doi: 10.1016/j.ypmed.2004.11.020.
PubMed 15917031Parry SW, Finch T, Deary V. How should we manage fear of falling in older adults living in the community? BMJ. 2013 May 28;346:f2933. doi: 10.1136/bmj.f2933. No abstract available.
PubMed 23714190Sherrington C, Tiedemann A, Fairhall N, Close JC, Lord SR. Exercise to prevent falls in older adults: an updated meta-analysis and best practice recommendations. N S W Public Health Bull. 2011 Jun;22(3-4):78-83. doi: 10.1071/NB10056.
PubMed 21632004Pelosin E, Barella R, Bet C, Magioncalda E, Putzolu M, Di Biasio F, Cerulli C, Casaleggio M, Abbruzzese G, Avanzino L. Effect of Group-Based Rehabilitation Combining Action Observation with Physiotherapy on Freezing of Gait in Parkinson's Disease. Neural Plast. 2018 May 27;2018:4897276. doi: 10.1155/2018/4897276. eCollection 2018.
PubMed 29977280Buccino G. Action observation treatment: a novel tool in neurorehabilitation. Philos Trans R Soc Lond B Biol Sci. 2014 Apr 28;369(1644):20130185. doi: 10.1098/rstb.2013.0185. Print 2014.
PubMed 24778380Caligiore D, Mustile M, Spalletta G, Baldassarre G. Action observation and motor imagery for rehabilitation in Parkinson's disease: A systematic review and an integrative hypothesis. Neurosci Biobehav Rev. 2017 Jan;72:210-222. doi: 10.1016/j.neubiorev.2016.11.005. Epub 2016 Nov 16.
PubMed 27865800Villafane JH, Pirali C, Isgro M, Vanti C, Buraschi R, Negrini S. Effects of Action Observation Therapy in Patients Recovering From Total Hip Arthroplasty Arthroplasty: A Prospective Clinical Trial. J Chiropr Med. 2016 Dec;15(4):229-234. doi: 10.1016/j.jcm.2016.08.011. Epub 2016 Oct 5.
PubMed 27857630Zhu MH, Wang J, Gu XD, Shi MF, Zeng M, Wang CY, Chen QY, Fu JM. Effect of action observation therapy on daily activities and motor recovery in stroke patients.International Journal of Nursing Sciences. 2015 Sep 1;2(3):279-82.
Gardner MM, Buchner DM, Robertson MC, Campbell AJ. Practical implementation of an exercise-based falls prevention programme. Age Ageing. 2001 Jan;30(1):77-83. doi: 10.1093/ageing/30.1.77.
PubMed 11322678Çifcili S,Ünalan P.Yaşlılarda fonksiyonel kayıplara yaklaşım.Turk Aile Hek Dergisi 2004;8:166-173.
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Action Observation Training Combined With Exercises on Balance and Risk of Fall Over 65 Years Old
- ClinicalTrials.gov ID
- NCT04759690
- Acronym / sponsor ID
- p3957ghb
- Conditions
- Fall Prevention, Elderly
- Keywords
- Aging, Action observation, Balance exercise, Fall prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 12 Dec 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 18 Feb 2021 (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.
With aging, the decrease in muscle strength in the musculoskeletal system , body biomechanics and posture changes and the risk of falling increase. The greatest danger of falling in this population is risky and the other danger is that it causes fractures, creates physical and psychological trauma, and increases the need for long-term care and health services. Increasing exercise efficiency for balance and preventing falls are extremely important for physical and cognitive health.
İn recent years ,the''Action Observation''approach has been used as an added method to treatments to increase the effectiveness of exercise.Action observation ; it is a cognitive training that triggers motor learning by observing the desired activity and positively affects learning.
The aim of the study : To investigate the effects of exercises on balance and fall risk together with action observation in individuals over 65 years of age . The researchers planned to combine action observation and traditional balance exercises as a group training and compare them with the control group .
The hypothesis of the research is that action observation(AO) will be more useful in maintaining balance and preventing the risk of falling.
Materials and methods of the research:Participants will consist of volunteers over 65 years of age(65-80 years old ). 60 participants to be selected randomly. The participants will be randomly assigned 2 groups.
Experimental group :( 30 participants ) Action observation+ exercise combination Control group :( 30 participants ) will only exercise Study protocol:The randomized experimental and control group will study 3 days per week for a total of 8 weeks .Exercises difficulty;Borg Scale(0-10):It will be modarate.
Evaluation:All evaluations will be made as a Pre-test/Post-test. The detailed descriptions and characteristics of the participants will be summarized at baseline and after 8 weeks, and the differences between groups, intergroup differences will be statistically evaluated.
Detailed description
Purpose of the research:To investigate the effects of exercises combined with action observation on balance and fall risk in individuals over 65 years of age.
The hypothesis of the research is that action observation will be more useful in maintaining balance and preventing the risk of failling.
Action observation therapy (AOT)is a novel rehabilitation technique, which involves observation of purposeful actions with the intention to imitate and then performing those actions. AOT can be described as the patient being asked to carefully observe actions presented through a video-clip or performed by an operator, in order to imitate, try, and execute them after observation .This may include the mirror neuron system (MNS) processes on the upper limb function resulting from the observation of actions (new motor skills) and actual execution of similar neural structures . Current evidence have been limited to investigating AOT effectiveness on upper and lower limb rehabilitation in both neurological and orthopedic disorders, patients with stroke and brain injuries, limb pain, Parkinson disease, and in the old women. However, despite the volume of our understanding, there is a dearth of current scientific evidence evaluating the efficacy of AOT combined with exercises on balance and risk of fall in elderly both in men and women.
Study Power Analysis:The effect size was calculated using the G Power Package Program(G Power 3.0.10) over the data of the reference article(Leem SH et al,2019).The sample size required for the study according to the calculated effect size was determined as at least 38 participants for %95 power and Type I error rate (alpha):0.05 were calculated.To increase the power of our study, we invited 100 volunteer participants and after the exclusion criteria, we started with 60 participants, but with 43 participants.We were able to complete our work.
Our research is a randomized, controlled experimental study that examines the effect of Action Observation Therapy (EGT) on balance and fall risk in individuals over the age of 65, with a probabilistic, systematic sample.
Study protocol:
Participants will be randomly divided into two groups as experimental and control groups.
Experimental group participants:(n=30) Action observation+ exercise combination Control group participants:(n=30) Only exercise A total of 43 participants completed the study as 22 participants in the experimental group and 21 participants in the control group for various reasons.
Experimental group , the participants will be asked to carefully observe actions presented through a video-clip exercise for 15 minutes, and then do same exercises for about 45 minutes in 5-10 repetitions.
The Control group (only exercise group), the participants will perform exercises for about 45 minutes in 5-10 repetitions without a video-clip observation.
Study program:3 days a week for 8 weeks Exercise difficulty:Modified Borg Scale(0-10); The modified Borg Scale was used to evaluate the intensity and difficulty grades of the exercises . Initially, the scores of 3 and 4 were applied, and a gradual increase up to 5 and 6 at the end of the studyExercise program:Exercises will be easy to learn but not complex in terms of recall and performans. Depending on the fitness of the person, %50-75 of the maximum heart rate (220-years),the exercise intensity will be preferred over the Borg Scale.
The center where the research will be conducted ,İstanbul-Beşiktaş District Abbasağa neighborhood.
Exercises;sitting and standing from easy to difficult; it will be advanced from those done with two feed touching the ground to those done on one foot and walking. It will include warm-up period, strengthening exercises ,static and dynamic balance exercises, flexibility exercises and cooling periods. The exercises were repeated 5 times initially. Then their repetition numbers were gradually increased up to 8-10 repetitions in small groups of 5-7 people.All AOT and exercise programs were performed in the Abbasağa garden park, a quiet place without noise. We obtained local permission from Besiktas Municipality, Istanbul, Turkey, and applied the general rules for the COVID-19 pandemic.The participant registration and acceptance of this study and the implementation of the exercises protocol were made by the same research physical therapist.
Study start date: December-2020
Study application date: 1 April / 31 May 2021
Completion of research: December-2021
Evaluation: All evaluations will be made as a Pre-test/ Post-test The detailed descriptions and characteristics of the participants will be summarized at baseline and after 8 weeks, and the differences between groups, intergroup differences will be statistically evaluated.
Socio-demographic evaluation Blood pressure and heart rate measurement Mini-Mental Test İnternational Physical Activity Questionnaire Short Form(IPAQ-Short)
Cognitive Level Tests :
Montreal Cognitive Assessment(MoCA)
Balance and Fall Risk Tests:
Time Up\&Go Test(TUG) 5 Times Sit \& Stand Test Tinetti Balance and Walk Test Activity Specific Balance Confidence Scale(ABC) BORG Scale (0-10): To determine exercise intensity I have prepared '' Pain Location and İntensity" and "Fall Frequency Questioning"and "Participant Satisfaction" evaluation forms in the last year.
Statistical evaluation: The evaluation of the all data will be done using the SPSS statistical package program.The data will be analyzed using the SPSS program with the significance level of p<0.05
İstanbul Medıpol Unıversıty Non-İnterventional Clinical Research Ethıcs Committee Permission of the research was obteined(Number:10840098-772.02-E.58328,Date:10/26/2020).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cross-sectional sampling / Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Action observation and exercise group | Experimental | Behavioral: Action observation, Behavioral: Exercise groupAction observation group consist of 30 randomly selected participants.Action observation + conventional balance exercise group |
| Exercise group | Other | Behavioral: Exercise groupExercise group is the control group.Consist of 30 randomly selected participants. The participants will only do the conventional balance exercise. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Those who volunteered to participate in the study and between the ages of 65 and 80
- Who scored 24 or more out of 30 points in the Standardized Mini-Mental Test (SMMT)
- Non-neurological or orthopedic problems
- Had vision and hearing problems at a level that would prevent participation in the study.
Key exclusion criteria (5 listed)
- Those who have any neurological, internal or orthopedic problems that may affect the balance,
- Those with unstable hypertension and diabetes,
- Those with a diagnosis of Chronic Obstructive Pulmonary Disease (COPD),
- Those who have had a surgical procedure that may affect the balance in the last 6 months were excluded from the study.
- Wheelchair dependents
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 |
|---|---|---|
| Action observationAlso: Conventional balance exercisesAction observation group: The participants will first watch the conventional balance exercises with the action observation method on video for 15 minutes.After watching of conventional balance exercise for 45 minutes in 5-10 repetitions. | Behavioural | Action observation and exercise group |
| Exercise groupExercise group is the control group.TheParticipants will only do the conventional balance exercise without action observation for 45 minutes in 5-10 repetitions. | Behavioural | Action observation and exercise group, Exercise group |
Primary outcome
Mini-Mental State Examination
Time frame: Baseline
Mini Mental State Test is a short test used for dementia screening. It consists of ten questions. It measures orientation, memory, attention, calculation, language, motor function and perception, immediate and brief recall, language and simple verbal and written instructions as well as visual construction. The test is evaluated over 30 points. Between 24-30 points is considered normal and below 23 points is considered risk of dementia.This test is also affected by age and education level. The test used as the acceptance of the study participants to the research.
Baseline characteristics of the participants
Time frame: Baseline
To interpret the results of our study, baseline characteristics of the participants including age, gender, education, marital status, height, weight will be recorded.
Montreal Cognitive Assessment Scale
Time frame: Baseline to end of week 8 when the study is completed.
Montreal Cognitive Assessment Scale is a rapid screening test for measuring cognitive level and mild cognitive impairment. With the Montreal Cognitive Assessment Test, 8 different cognitive functions are evaluated: attention and concentration, executive functions, memory, language, visual structuring skills, abstract thinking, calculation and orientation. The highest score that can be obtained from the test is 30. Accordingly, 21 points and above is considered normal.
The International Physical Activity Questionnaire short form
Time frame: Baseline.
The short form IPAQ is a 7-item scale, assessing the amount of minutes spent in vigorous and moderate intense activity and walking during the last 7 days. For all categories, the amount of Metabolic Equivalents (METs) minutes is calculated by multiplying the amount of minutes with 8 (vigorous), 4 (moderate), 3.3 (walking), or 1.3 (sitting).
Five Times Sit-to-Stand Test
Time frame: Baseline to end of week 8 when the study is completed.
The Five Times Sit and Stand Test is a clinical test that investigates postural control and lower extremity muscle strength. It is determined by measuring the time to complete the sitting-stand up activity at least five times with a stopwatch. Completion time below 12 seconds is considered a risk for recurrent falls.
Tinetti Balance and Gait Scale
Time frame: Baseline to end of week 8 when the study is completed.
Tinetti's balance and gait scale is used to determine fall risk, especially in the elderly. It is a combination of two scales, one evaluating balance and gait characteristics. The full scale is calculated by summing the questions consisting of 9 items for balance and 7 items for walking, and evaluation scores such as 0-1-2. It is calculated by adding a maximum balance score of 16 points and a maximum walking score of 12 points. The total score is 28 as balance + walking. 18 points and below indicate high fall risk, 19-24 points medium fall risk, 24 points and above indicate low fall risk.
Activity Specific Balance Confidence Scale
Time frame: Baseline to end of week 8 when the study is completed.
Activity Specific Balance Confidence Scale was developed by Powell and Myers. This scale includes 16 tasks related to indoor and outdoor activities of daily living to balance trust in older people with varying levels of functioning. Scores range from 0 percent (no confidence) to 100 percent (complete confidence) for each question item. Higher scores with a percentage increase indicate more confidence.
Heart rate measurement
Time frame: Day 1
There are many circulatory changes that occur during exercise to supply the tremendous blood flow required by the muscles including the stimulatory effects on the circulation by the mass sympathetic discharge, the increased arterial pressure and cardiac output. These cardiovascular responses is important that adults, and elderly normal people due to the age related. It was preferred that the exercises should be percent of the maximum heart rate (220-age) according to the fitness level of the participant and the exercise difficulty level should be at the moderate.
Borg Scale assessment of perceived effort
Time frame: Day 1
Borg Scale It is the marking of the exercise intensity, which is determined by a certain percentage of the calculation of the maximum heart rate according to the fitness level of the participant, by expressing the exercise intensity in the form with numbers 1-10.The exercise difficulty is indicated by the numbers 1 through 10, with 1 being the easiest and 10 the hardest.
International Physical Activity Questionnaire Short Form
Time frame: Baseline
This is a questionnaire scale to determine the physical activity levels of the participants. This questionnaire consists of 4 parts as work, transportation, rest and sports activities. It is a 9-item scale that evaluates the amount of minutes spent for at least 10 minutes of vigorous, moderate activities and walking categories during the last 7 days. It is calculated by multiplying the minutes spent in each category by the metabolic equivalent. Under the 600 metabolic equivalents are considered inactive, 600-3000 metabolic equivalents minimum active and 3000 metabolic equivalents as active.
The Timed Up and Go Test
Time frame: Baseline to end of week 8 when the study is completed.
In balance and fall risk assessments, the Timed Get Up and Go Test (TUGT) is a simple and very useful test.A chair and stopwatch are required for this test.The area of 3 meters in front of the chair is determined. The patient is asked to get up from the chair and walk this distance and sit down again.If an elderly individual completes this test in more than 12 seconds, there is a risk of falling
2 secondary outcomes
The frequency of falling
Time frame: Baseline
Clinical pain location and pain intensity
Time frame: Baseline to end of week 8 when the study is completed.
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 2 May 2022.
- Background: PubMed 31938708Leem SH, Kim JH, Lee BH. Effects of Otago exercise combined with action observation training on balance and gait in the old people. J Exerc Rehabil. 2019 Dec 31;15(6):848-854. doi: 10.12965/jer.1938720.360. eCollection 2019 Dec.
- Background: PubMed 11388435Gangitano M, Mottaghy FM, Pascual-Leone A. Phase-specific modulation of cortical motor output during movement observation. Neuroreport. 2001 May 25;12(7):1489-92. doi: 10.1097/00001756-200105250-00038.
- Background: PubMed 19940323Bird ML, Hill K, Ball M, Williams AD. Effects of resistance- and flexibility-exercise interventions on balance and related measures in older adults. J Aging Phys Act. 2009 Oct;17(4):444-54. doi: 10.1123/japa.17.4.444.
- Background: PubMed 30210995Martins AC, Santos C, Silva C, Baltazar D, Moreira J, Tavares N. Does modified Otago Exercise Program improves balance in older people? A systematic review. Prev Med Rep. 2018 Jul 10;11:231-239. doi: 10.1016/j.pmedr.2018.06.015. eCollection 2018 Sep.
- BackgroundTettamanti A, Paci E, Pelachin M, Cattrysse E, Kerckhofs E, Gatti R. Effevt of action observation training on balance performance in healthy subjects.www.physiotherapyjournal 2015:101(1);1502.
- Background: PubMed 15917031Hirvensalo M, Heikkinen E, Lintunen T, Rantanen T. Recommendations for and warnings against physical activity given to older people by health care professionals. Prev Med. 2005 Jul;41(1):342-7. doi: 10.1016/j.ypmed.2004.11.020.
- Background: PubMed 23714190Parry SW, Finch T, Deary V. How should we manage fear of falling in older adults living in the community? BMJ. 2013 May 28;346:f2933. doi: 10.1136/bmj.f2933. No abstract available.
- Background: PubMed 21632004Sherrington C, Tiedemann A, Fairhall N, Close JC, Lord SR. Exercise to prevent falls in older adults: an updated meta-analysis and best practice recommendations. N S W Public Health Bull. 2011 Jun;22(3-4):78-83. doi: 10.1071/NB10056.
- Background: PubMed 29977280Pelosin E, Barella R, Bet C, Magioncalda E, Putzolu M, Di Biasio F, Cerulli C, Casaleggio M, Abbruzzese G, Avanzino L. Effect of Group-Based Rehabilitation Combining Action Observation with Physiotherapy on Freezing of Gait in Parkinson's Disease. Neural Plast. 2018 May 27;2018:4897276. doi: 10.1155/2018/4897276. eCollection 2018.
- Background: PubMed 24778380Buccino G. Action observation treatment: a novel tool in neurorehabilitation. Philos Trans R Soc Lond B Biol Sci. 2014 Apr 28;369(1644):20130185. doi: 10.1098/rstb.2013.0185. Print 2014.
- Background: PubMed 27865800Caligiore D, Mustile M, Spalletta G, Baldassarre G. Action observation and motor imagery for rehabilitation in Parkinson's disease: A systematic review and an integrative hypothesis. Neurosci Biobehav Rev. 2017 Jan;72:210-222. doi: 10.1016/j.neubiorev.2016.11.005. Epub 2016 Nov 16.
- Background: PubMed 27857630Villafane JH, Pirali C, Isgro M, Vanti C, Buraschi R, Negrini S. Effects of Action Observation Therapy in Patients Recovering From Total Hip Arthroplasty Arthroplasty: A Prospective Clinical Trial. J Chiropr Med. 2016 Dec;15(4):229-234. doi: 10.1016/j.jcm.2016.08.011. Epub 2016 Oct 5.
- Individual participant dataSharing planned: No. I can consider publishing my research as a doctoral thesis and related article.
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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.
Bağdat TEKKUŞ, 1 principal investigator
Istanbul MEDİPOL University ,İnstitute of Health Sciences Kavacık Campus-İstanbul TURKEY
Fatma MUTLUAY, 2 study director
Istanbul MEDİPOL University Faculty of Health Sciences Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Action observation and Exercise group in people with Fall Prevention and Elderly, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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 4 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 2 May 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 Turkey (Türkiye). 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?
Mini-Mental State Examination (time frame: Baseline). The study lists 11 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 NCT04759690, which also lists 38 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 2 May 2022.