Effects of Action Observation Training and Exercises Over 65 Years Old
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| ClinicalTrials.gov Identifier: NCT04759690 |
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Recruitment Status :
Enrolling by invitation
First Posted : February 18, 2021
Last Update Posted : February 18, 2021
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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 . 38 participants to be selected randomly. The participants will be randomly assigned 2 groups.
Experimental group :( 19 participants ) Action observation+ exercise combination Control group :( 19 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Fall Prevention Elderly | Behavioral: Action observation Behavioral: Exercise group | Not Applicable |
Show detailed description
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 38 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Cross-sectional sampling / Randomized controlled trial |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Effects of Action Observation Training Combined With Exercises on Balance and Risk of Fall Over 65 Years Old |
| Actual Study Start Date : | December 12, 2020 |
| Estimated Primary Completion Date : | June 5, 2021 |
| Estimated Study Completion Date : | December 12, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Action observation group
Action observation group consist of 19 randomly selected participants.Action observation + conventional balance exercise group
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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 30 minutes in 8-10 repetitions.
Other Name: Conventional balance exercises Behavioral: Exercise group Exercise group is the control group.TheParticipants will only do the conventional balance exercise without action observation for 30 minutes in 8-10 repetitions. |
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Active Comparator: Exercise group
Exercise group is the control group.Consist of 19 randomly selected participants. the The participants will only do the conventional balance exercise.
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Behavioral: Exercise group
Exercise group is the control group.TheParticipants will only do the conventional balance exercise without action observation for 30 minutes in 8-10 repetitions. |
- 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 9-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 15 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 13 items for balance and 9 items for walking, and evaluation scores such as 0-1-2. It is calculated by adding a maximum balance score of 26 points and a maximum walking score of 9 points. The total score is 35 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 frequency of falling [ Time Frame: Baseline ]The frequency of falling will be determined by self questioning
- Clinical pain location and pain intensity [ Time Frame: Baseline to end of week 8 when the study is completed. ]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".
- Research Participant Satisfaction Questionnaire [ Time Frame: At the end of the 8th week of completion. ]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
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| Ages Eligible for Study: | 65 Years to 80 Years (Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Participants not diagnosed with clinical dementia (A score of 23 or more out of 30 from the Mini-Mental Test)
- Participants ages between 65-80
- No visual, auditory or vestibular problems
- No limb defects
Exclusion Criteria:
- Cardiovascular or cerebrovascular disease, traumatic brain injury, epilepsy
- Abnormalities in visual, auditory or vestibular organs
- Limb defects
- Chronic obstructive pulmonary disease (COPD)
- a surgical procedure that may affect balance in the last 6 months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04759690
| Turkey | |
| Istanbul Medipol University Kavacık Campus | |
| İstanbul, Kavacık, Turkey, 34810 | |
| 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 |
| Responsible Party: | bagdattekkus, Principal Investigator, physiotherapist, Istanbul Medipol University Hospital |
| ClinicalTrials.gov Identifier: | NCT04759690 |
| Other Study ID Numbers: |
p3957ghb |
| First Posted: | February 18, 2021 Key Record Dates |
| Last Update Posted: | February 18, 2021 |
| Last Verified: | February 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | I can consider publishing my research as a doctoral thesis and related article. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Aging Action observation Balance exercise Fall prevention |