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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06106217
Other study ID # istanbul MUH
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date July 1, 2023
Est. completion date January 30, 2024

Study information

Verified date November 2023
Source Istanbul Medipol University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Geriatric problems develop with aging in individuals over 60 years of age. These problems include muscle weakness, balance disorders and changes in quality of life. The aim of our study is to examine the effects of BAPNE (BMe) and qi gong (QG) exercises on balance and quality of life in individuals over the age of 60. In this study, parameters such as fall risk, muscle testing, balance, functional capacity, cognitive functions, depression and sleep quality were evaluated. 56 participants were included in the study. All cases were evaluated for the first time before they were included in the study. In the initial evaluation, Itaki fall risk questionnaire, 6-minute walk test, Berg balance scale, Pittsburg sleep quality index, World Health Organization quality of life scale elderly module, Beck depression scale, mini mental state test, object flipping test, word fluency test, stroop test, muscle strength with Jtech brand myometer and balance on Libra balance board were measured. Participants were divided into groups of 2-6 people, and second assessments were made after a total of 20 sessions of BMe exercises for 6 weeks. After a 2-week rest period, the participants were included in the third assessment and included a total of 20 sessions of QG exercise over 6 weeks. At the end of 6 weeks, the fourth evaluation was made.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 57
Est. completion date January 30, 2024
Est. primary completion date January 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 99 Years
Eligibility Inclusion Criteria: - Be 60 years old or older - Able to walk independently - Volunteering to exercise at least 3 days a week within the scope of the research Exclusion Criteria: - Having an orthopedic or surgical problem that prevents walking or exercising - Having any neurological problems - The presence of a pulmonary, cardiac, or systemic disease that would constitute a contraindication for exercise.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
bapne
An exercise program was created in the form of a movement sequence consisting of nine movement combinations.
qi gong
The exercise program, which was prepared in a 40-minute sequence, was arranged as 10 minutes of warm-up, 20 minutes of Qi Gong exercises, and 10 minutes of cool-down.

Locations

Country Name City State
Turkey Istanbul Medipol University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

Emek Savas DD, Yerlikaya D, G Yener G, Oktem Tanor O. Validity, Reliability and Normative Data of the Stroop Test Capa Version. Turk Psikiyatri Derg. 2020 Spring;31(1):9-21. doi: 10.5080/u23549. English, Turkish. — View Citation

Figueira HA, Figueira OA, Figueira AA, Figueira JA, Polo-Ledesma RE, Lyra da Silva CR, Dantas EHM. Impact of Physical Activity on Anxiety, Depression, Stress and Quality of Life of the Older People in Brazil. Int J Environ Res Public Health. 2023 Jan 8;20(2):1127. doi: 10.3390/ijerph20021127. — View Citation

Fu H, Wang L, Zhang W, Lu J, Yang M. Diagnostic test accuracy of ultrasound for sarcopenia diagnosis: A systematic review and meta-analysis. J Cachexia Sarcopenia Muscle. 2023 Feb;14(1):57-70. doi: 10.1002/jcsm.13149. Epub 2022 Dec 13. — View Citation

Hachenberger J, Li YM, Lemola S. Physical activity, sleep and affective wellbeing on the following day: An experience sampling study. J Sleep Res. 2023 Apr;32(2):e13723. doi: 10.1111/jsr.13723. Epub 2022 Sep 18. — View Citation

Kim SG, Lim DH, Cho YH. Analysis of the reliability of the make test in young adults by using a hand-held dynamometer. J Phys Ther Sci. 2016 Aug;28(8):2238-40. doi: 10.1589/jpts.28.2238. Epub 2016 Aug 31. — View Citation

Terrés JMP, Naranjo FJR, Martimez AC, Colomino NC. Perceptions towards wellness and life quality through body percussion BAPNE Method and cognitive stimulation in elderly people. Procedia - Social and Behavioral Sciences 152,1108 - 1113, 2014.

Zhang H, Yin L, Peng Y, Zhang G, Chen Q, Liang J, Tian S, Tong T, Liu R, Lv C, Zhao L, Liang T, Wang J, Fan L. Effect of five-elements music therapy combined with Baduanjin qigong on patients with mild COVID-19. Hong Kong J Occup Ther. 2023 Jun;36(1):31-38. doi: 10.1177/15691861231167536. Epub 2023 Apr 12. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Ithaki Fall Risk Questionnaire This developed scale consists of a total of 19 risk factors, including risk factors that may cause patient falls. Risk factors were categorized as major and minor, and minor risk factors were given 1 point and major risk factors were given 5 points. Two risk levels, low and high, were determined over the total score obtained as a result of the evaluation of risk factors. In order to distinguish high-risk patients and to take necessary precautions, it is envisaged to use the "Four Leaf Clover" figure in patients at high risk of falling. 14 weeks
Primary Berg Balance Scale Berg balance scale is a valid, reliable and sensitive measurement method that measures functional balance. The test, which includes 14 functional tests and is completed in an average of 10-20 minutes, has a score between 0-4. At 0, the loss of balance is maximum, while at a value of 4, the patient is independent of balance. The maximum score of the test is 56, and the minimum score is 0. A high score indicates good functional balance. 14 weeks
Primary Libra Balance Board Balance board produced by Easytech is a computer aided balance measuring device. This device measures 42x9x42 cm and weighs 2.7 kilograms. It gives a score out of 100, 0 points the best balance and 100 points the worst balance. 14 weeks
Primary Pittsburgh Sleep Quality Index Buysse et al. It is a scale that defines good and bad sleep, developed by in 1989. A total of 24 questions, 19 of which are self-assessed, and 5 are answered by a roommate or spouse. These assess sleep duration, latency, and the frequency and severity of specific sleep-related problems. Evaluated with points between 0-3. 14 weeks
Primary WHOQOL-old It consists of 24 questions translated into Turkish as the World Health Organization quality of life module for the elderly. Validity reliability Eser S. et al. module made by; autonomy, past present and future activities, social inheritance, death-death and intimacy. 14 weeks
Secondary Demographic information Name, surname, date of birth, gender, address, education level of the participants who participated in the study were recorded. They were recorded in the demographic information form. Baseline (only in the first evaluation)
Secondary Muscle Strength Rating Electronic myometer was used to evaluate muscle strength. Muscle strength was measured with a Jtech brand myometer. To hip flexors, extensors, abductors and adductors, knee extensors and flexors, ankle plantar and dorsi flexors, trunk extensors and abdominals, shoulder abductors, adductors, flexors and extensors, elbow flexors and extensors, wrist flexors and extensors, wrist flexor muscle and extensors will be applied. The muscle test will be performed on the dominant side for the extremities. 14 weeks
Secondary 6 Minute Walk Test The 6-minute walk test is one of the tests that reflects functional performance. This test is carried out in a 30-meter corridor with the dimensions of 10x40 meters. Patients are asked to walk at the highest speed they can walk for 6 minutes, but without running. The patients are encouraged verbally before and during the walk and it is ensured that they do not lose their motivation. As a result of the test, blood pressure and heart rate values, how many meters they walked in 6 minutes are recorded. 14 weeks
Secondary Beck Depression Scale It is a tool used to measure the severity of depression with 21 multiple-choice questions created by Aaron T. Beck and a Turkish version of the study. The symptoms of depression show up in our emotions and our bodies. Beck depression scale measures both of these factors, thus providing a more comprehensive and accurate diagnosis. 14 weeks
Secondary Mini Mental Test First, Folstein et al. The test published by Molloy and Standish in 1997 and standardized by Güngen C. et al. Turkish validity and reliability study was conducted by It is a short, useful and standardized method that can be used to determine the cognitive level globally. 14 weeks
Secondary Stroop Test It consists of 60 boxes with random red, blue and green colors and 60 randomly arranged words "red", "green" and "blue" with different ink colors and different colors. The test consists of three main tasks. The time to finish the test, the number of errors and the number of spontaneous corrections are calculated. It is a complex test that evaluates multiple frontal lobe functions. In the test, the ability to perceive, the speed of processing information in the face of misleading stimuli, and the ability of the person's perception system to direct with distracting stimuli are evaluated. 14 weeks
Secondary Object Flip Test It is a test in which participants try to find the coin hidden in two blue and red glasses. If the coin is known correctly 12 times in a row, the experiment is terminated. Points are given according to the number of mistakes and a maximum of 50 repetitions can be done. The lowest score in this test indicates good OFT performance. 14 weeks
Secondary Vocabulary Fluency Test It is a test that takes 3 minutes in total. Participants who are asked to produce as many words as possible with the letters F, A and S are given one minute for each letter. The total number of words produced is determined as a score. 14 weeks
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