Effects of Action Observation Training and Exercises Over 65 Years Old

Elderly Clinical Trial

Official title:

Effects of Action Observation Training Combined With Exercises on Balance and Risk of Fall Over 65 Years Old

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04759690
• Other study ID #: p3957ghb
• Status: Completed
• Phase: N/A
• Start date: December 12, 2020
• Est. completion date: May 31, 2021

Study information

• Verified date: April 2022
• Source: Istanbul Medipol University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: May 31, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Elderly
• Fall Prevention

Intervention

Behavioral:
• Action observation
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 group
Exercise group is the control group.TheParticipants will only do the conventional balance exercise without action observation for 45 minutes in 5-10 repetitions.

Locations

Country	Name	City	State
Turkey	Istanbul Medipol University Kavacik Campus	Istanbul	Kavacik

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (36)

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* Note: There are 36 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Research Participant Satisfaction Questionnaire	In the questionnaire, we ask questions about the informed consent process, interaction with the research team, satisfaction with the study, and how easy it is to complete the study. Higher scores mean higher satisfaction	At the end of the 8th week of completion.
Primary	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.	Baseline
Primary	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.	Baseline
Primary	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.	Baseline to end of week 8 when the study is completed.
Primary	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).	Baseline.
Primary	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.	Baseline to end of week 8 when the study is completed.
Primary	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.	Baseline to end of week 8 when the study is completed.
Primary	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.	Baseline to end of week 8 when the study is completed.
Primary	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.	Day 1
Primary	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.	Day 1
Primary	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.	Baseline
Primary	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	Baseline to end of week 8 when the study is completed.
Secondary	The frequency of falling	The frequency of falling will be determined by self questioning	Baseline
Secondary	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".	Baseline to end of week 8 when the study is completed.