Recruitment

Recruitment Status
Enrolling by invitation
Estimated Enrollment
Same as current

Summary

Conditions
  • Elderly
  • Fall Prevention
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Cross-sectional sampling / Randomized controlled trialMasking: None (Open Label)Primary Purpose: Prevention

Participation Requirements

Age
Between 65 years and 80 years
Gender
Both males and females

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. Act...

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 38 participants for %95 power and Type I error rate (alpha):0.05 were calculated. Study protocol: Participants will be randomly divided into two groups as experimental and control groups. Experimental group participants:(n=19) Action observation+ exercise combination Control group participants:(n=19) Only exercise 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 30 minutes in 8-10 repetitions. The Control group (only exercise group), the participants will perform exercises for about 30 minutes in 8-10 repetitions without a video-clip observation. Study program:3 days a week for 8 weeks Exercise difficulty:Borg Scale(0-10); it will be moderate. Exercise 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 ,?stanbul-Be?ikta? District Abbasa?a 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 Each exercise will be performed 8-10 repetitions in small groups of 5-10 people. The study will be caried out in the Abbasa?a garden park. Study date: December-2020/Devember-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 ?nternational 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 ?ntensity" 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 ?stanbul Med?pol Un?vers?ty Non-?nterventional Clinical Research Eth?cs Committee Permission of the research was obteined(Number:10840098-772.02-E.58328,Date:10/26/2020).

Tracking Information

NCT #
NCT04759690
Collaborators
Not Provided
Investigators
Principal Investigator: Ba?dat TEKKU?, 1 Istanbul MED?POL University ,?nstitute of Health Sciences Kavac?k Campus-?stanbul TURKEY Study Director: Fatma MUTLUAY, 2 Istanbul MED?POL University Faculty of Health Sciences Professor