Clinical trial NCT04759690: Effects of Action Observation Training and Exercises Over 65 Years Old
Official title: Effects of Action Observation Training Combined With Exercises on Balance and Risk of Fall Over 65 Years Old
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fall Prevention
Elderly
Keywords: Aging
Action observation
Balance exercise
Fall prevention
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 43
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cross-sectional sampling / Randomized controlled trial
Primary purpose: PREVENTION

Brief 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 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).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Mini-Mental State Examination
timeFrame: Baseline
measure: Baseline characteristics of the participants
timeFrame: Baseline
measure: Montreal Cognitive Assessment Scale
timeFrame: Baseline to end of week 8 when the study is completed.
measure: The International Physical Activity Questionnaire short form
timeFrame: Baseline.
measure: Five Times Sit-to-Stand Test
timeFrame: Baseline to end of week 8 when the study is completed.
measure: Tinetti Balance and Gait Scale
timeFrame: Baseline to end of week 8 when the study is completed.
measure: Activity Specific Balance Confidence Scale
timeFrame: Baseline to end of week 8 when the study is completed.
measure: Heart rate measurement
timeFrame: Day 1
measure: Borg Scale assessment of perceived effort
timeFrame: Day 1
measure: International Physical Activity Questionnaire Short Form
timeFrame: Baseline
measure: The Timed Up and Go Test
timeFrame: Baseline to end of week 8 when the study is completed.
Secondary outcomes:
measure: The frequency of falling
timeFrame: Baseline
measure: Clinical pain location and pain intensity
timeFrame: Baseline to end of week 8 when the study is completed.
Other outcomes:
measure: Research Participant Satisfaction Questionnaire
timeFrame: At the end of the 8th week of completion.
Locations:
city: İstanbul
country: Turkey
facility: Istanbul Medipol University Kavacık Campus
state: Kavacık
Study officials:
affiliation: Istanbul MEDİPOL University ,İnstitute of Health Sciences Kavacık Campus-İstanbul TURKEY
name: Bağdat TEKKUŞ, 1
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul MEDİPOL University Faculty of Health Sciences Professor
name: Fatma MUTLUAY, 2
role: STUDY_DIRECTOR
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