Effects of Action Observation Training and Exercises Over 65 Years Old
1 other identifier
interventional
43
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 6, 2020
CompletedStudy Start
First participant enrolled
December 12, 2020
CompletedFirst Posted
Study publicly available on registry
February 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2021
CompletedMay 2, 2022
April 1, 2022
4 months
December 6, 2020
April 26, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (11)
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
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
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.
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.
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.
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.
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.
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
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
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
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 Outcomes (2)
The frequency of falling
Baseline
Clinical pain location and pain intensity
Baseline to end of week 8 when the study is completed.
Other Outcomes (1)
Research Participant Satisfaction Questionnaire
At the end of the 8th week of completion.
Study Arms (2)
Action observation and exercise group
EXPERIMENTALAction observation group consist of 30 randomly selected participants.Action observation + conventional balance exercise group
Exercise group
OTHERExercise group is the control group.Consist of 30 randomly selected participants. The participants will only do the conventional balance exercise.
Interventions
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 is the control group.TheParticipants will only do the conventional balance exercise without action observation for 45 minutes in 5-10 repetitions.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istanbul Medipol University Kavacık Campus
Istanbul, Kavacık, 34810, Turkey (Türkiye)
Related Publications (38)
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PMID: 39360568DERIVEDTekkus B, Mutluay F. Effect of community-based group exercises combined with action observation on physical and cognitive performance in older adults during the Covid-19 pandemic: A randomized controlled trial. PLoS One. 2023 Dec 5;18(12):e0295057. doi: 10.1371/journal.pone.0295057. eCollection 2023.
PMID: 38051723DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Bağdat TEKKUŞ, 1
Istanbul MEDİPOL University ,İnstitute of Health Sciences Kavacık Campus-İstanbul TURKEY
- STUDY DIRECTOR
Fatma MUTLUAY, 2
Istanbul MEDİPOL University Faculty of Health Sciences Professor
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, physiotherapist
Study Record Dates
First Submitted
December 6, 2020
First Posted
February 18, 2021
Study Start
December 12, 2020
Primary Completion
April 1, 2021
Study Completion
May 31, 2021
Last Updated
May 2, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share
I can consider publishing my research as a doctoral thesis and related article.