- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06106217
INVESTIGATION OF THE EFFECTS OF BAPNE AND QI GONG EXERCISES ON BALANCE AND QUALITY OF LIFE IN INDIVIDUALS OVER 60
November 27, 2023 updated by: yakup cemel, Istanbul Medipol University Hospital
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
57
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Istanbul, Turkey
- Istanbul Medipol University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: bapne
|
An exercise program was created in the form of a movement sequence consisting of nine movement combinations.
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Experimental: 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ithaki Fall Risk Questionnaire
Time Frame: 14 weeks
|
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.
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14 weeks
|
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Berg Balance Scale
Time Frame: 14 weeks
|
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.
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14 weeks
|
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Libra Balance Board
Time Frame: 14 weeks
|
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.
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14 weeks
|
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Pittsburgh Sleep Quality Index
Time Frame: 14 weeks
|
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.
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14 weeks
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WHOQOL-old
Time Frame: 14 weeks
|
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.
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14 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Demographic information
Time Frame: Baseline (only in the first evaluation)
|
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.
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Baseline (only in the first evaluation)
|
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Muscle Strength Rating
Time Frame: 14 weeks
|
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.
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14 weeks
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6 Minute Walk Test
Time Frame: 14 weeks
|
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.
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14 weeks
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Beck Depression Scale
Time Frame: 14 weeks
|
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.
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14 weeks
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Mini Mental Test
Time Frame: 14 weeks
|
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.
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14 weeks
|
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Stroop Test
Time Frame: 14 weeks
|
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.
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14 weeks
|
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Object Flip Test
Time Frame: 14 weeks
|
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.
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14 weeks
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Vocabulary Fluency Test
Time Frame: 14 weeks
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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.
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14 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2023
Primary Completion (Estimated)
January 30, 2024
Study Completion (Estimated)
January 30, 2024
Study Registration Dates
First Submitted
October 12, 2023
First Submitted That Met QC Criteria
October 27, 2023
First Posted (Actual)
October 30, 2023
Study Record Updates
Last Update Posted (Actual)
November 28, 2023
Last Update Submitted That Met QC Criteria
November 27, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- istanbul MUH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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