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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05213091
Other study ID # 2021-465
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 20, 2021
Est. completion date August 15, 2022

Study information

Verified date September 2022
Source Gazi University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Home-based and individually designed exercise program; It consists of warming up, strengthening, balance exercises and walking plan. The number, intensity and duration of the movements are personalized according to preference and ability and are progressed gradually. Elderly individuals are expected to do this set of exercises three times a week and walk for 30 minutes twice a week. Since the Otago Exercise Programme includes combined exercises, the outputs of the effectiveness of the program will be different. For this purpose, the effect of otago exercises on fear of falling, balance, strengthening and functional mobility will be determined in the elderly living in nursing homes.


Description:

The first four weeks will be Otago Exercise Programme training and practice. For the next weeks, there will be institution visits and telephone interviews. Individuals will be given an Otago Exercise Programme training booklet, exercise chart and exercise diary to better manage this process. The research will be conducted in small groups (average 6-8). The control group is expected to continue their daily life. No attempt will be made by the researcher during the research process. Stratified randomization method according to age and gender was used in the study. The website was used to assign individuals meeting the inclusion criteria in each stratum to a determined number of groups. Masking will be done in terms of research data/output measurements (evaluator), statistician and reporting.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date August 15, 2022
Est. primary completion date April 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - To be 65 years or older - To be literate - Having no problem in verbal communication - Not having a disability based on sight, hearing and lack of limbs - Obtaining at least 91 points or more according to the Barthel Activities of Daily Living Index (to be mildly dependent or completely independent) - Mini Mental Test to be 24 points and above - Having a doctor's report that it will not interfere with exercise Exclusion Criteria: - Having a medical contraindication for exercise - Having acute or terminal illnesses and serious chronic illnesses that limit participation in exercise sessions - Having a lower extremity fracture in the past year - Having had an operation in the last month - Being diagnosed with any neuropsychiatric disease

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Otago Exercise Programme
The first four weeks will be Otago Exercise Programme training and practice. For the next weeks, there will be institution visits and telephone interviews. Individuals will be given an Otago Exercise Programme training booklet, exercise chart and exercise diary to better manage this process. The research will be conducted in small groups (average 6-8).

Locations

Country Name City State
Turkey Gazi University Ankara Çankaya/Ankara

Sponsors (1)

Lead Sponsor Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Modified Fall Efficacy Scale The scale is used to determine the possible fear of falling in elderly individuals. It is a visual analog scale consisting of fourteen questions. Items are scored from zero to ten (never safe=0, totally safe=10). A high score means high fall safety and proficiency. Totally 12 weeks
Primary Berg Balance Scale The scale was developed to evaluate the balance levels of elderly individuals. This scale consists of 14 items and each section is scored between 0 (bad) and 4 (best). The scale score is in the range of 0-56 points, and an increase in the score indicates that the balance is good. According to the total score obtained, "0-20 points: high risk of falling, balance disorder", "21-40 points: moderate risk of falling, presence of acceptable balance", "41-56 points: low risk of falling, presence of good balance" evaluated as ". Totally 12 weeks
Primary Elderly Empowerment Scale The scale is a short and practical tool for assessing the empowerment levels of the elderly. The scale, which consists of a total of eight questions and a single factor, is in the five-point Likert type. The lowest score obtained from the scale is 8, the highest score is 40. Totally 12 weeks
Primary 30-Second Chair Stand Test It is a test that evaluates the sit-to-stand activity, lower extremity strength and dynamic balance of the individual. The number of times an individual sits and stands in 30 seconds is recorded. Three measurements will be made by giving rest intervals and the average will be recorded. Totally 12 weeks
Primary Handgrip Strength Measurement Test The purpose of the test is to test the maximum isometric contraction strength of the forearm muscles. The average of the three measurements will be taken and recorded. Totally 12 weeks
Primary Timed Up & Go It is a test that evaluates mobility and fall risk in elderly individuals. The individual is observed while getting up from the chair, walking 3 meters, turning, walking back and sitting again, and the elapsed time is recorded. If the elderly person completes this test in more than 12 seconds, it is considered as "at risk of falling". Three measurements will be made by giving rest intervals and the average will be taken. Totally 12 weeks
Primary 6-Minute Walk Test It was developed to measure the functional capacity of individuals. In the six-minute walking test, the patient walks along a 30-meter straight corridor as fast as he can, but without running. How many meters he walked is measured and recorded. Three measurements will be made by giving rest intervals and the average will be recorded. Totally 12 weeks
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