Biomechanics, Anatomy, Psychology, Neuroscience, Ethnomusicology MethodNCT06106217
INVESTIGATION OF THE EFFECTS OF BAPNE AND QI GONG EXERCISES ON BALANCE AND QUALITY OF LIFE IN INDIVIDUALS OVER 60
A study testing bapne and qi gong in people with Biomechanics, Anatomy, Psychology, Neuroscience, Ethnomusicology Method and qi Gong, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 60 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Biomechanics, Anatomy, Psychology, Neuroscience, Ethnomusicology Method, qi Gong, Quality of Life
- What is being tested?
- bapne and qi gong
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2023to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Biomechanics, Anatomy, Psychology, Neuroscience, Ethnomusicology Method, qi Gong, Quality of Life, Balance
- Being tested
- bapne, qi gong
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bapneOther
An exercise program was created in the form of a movement sequence consisting of nine movement combinations.
qi gongOther
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.
| Study group | Role | What they receive |
|---|---|---|
| bapne | Experimental | Not described Receives: Other: bapne |
| qi gong | Experimental | Not described Receives: Other: qi gong |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 weeks
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.
Measured: 14 weeks
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.
Measured: 14 weeks
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.
Measured: 14 weeks
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.
Measured: 14 weeks
Secondary outcomes (8)
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.
Measured: Baseline (only in the first evaluation)
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.
Measured: 14 weeks
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.
Measured: 14 weeks
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.
Measured: 14 weeks
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.
Measured: 14 weeks
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.
Measured: 14 weeks
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.
Measured: 14 weeks
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.
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start1 Jul 2023
- Primary completion30 Jan 2024 (estimated)
- Study completion30 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Biomechanics, Anatomy, Psychology, Neuroscience, Ethnomusicology MethodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yakup cemel, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06106217
- Sponsor's protocol ID
- istanbul MUH
- Status last verified
- Nov 2023
- First submitted
- 12 Oct 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 36116773Zhang 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.
PubMed 37332295Emek 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.
PubMed 32594475Figueira 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.
PubMed 36673880Kim 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.
PubMed 27630404Fu 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.
PubMed 36513380Terrés 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 at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INVESTIGATION OF THE EFFECTS OF BAPNE AND QI GONG EXERCISES ON BALANCE AND QUALITY OF LIFE IN INDIVIDUALS OVER 60
- ClinicalTrials.gov ID
- NCT06106217
- Acronym / sponsor ID
- istanbul MUH
- Conditions
- Biomechanics, Anatomy, Psychology, Neuroscience, Ethnomusicology Method, qi Gong, Quality of Life, Balance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Jan 2024 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 30 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bapne | Experimental | Other: bapne |
| qi gong | Experimental | Other: qi gong |
Who may qualify
- Ages
- 60 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bapneAn exercise program was created in the form of a movement sequence consisting of nine movement combinations. | Other | bapne |
| qi gongThe 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. | Other | qi gong |
Primary outcome
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.
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.
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.
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.
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.
8 secondary outcomes
Demographic information
Time frame: Baseline (only in the first evaluation)
Muscle Strength Rating
Time frame: 14 weeks
6 Minute Walk Test
Time frame: 14 weeks
Beck Depression Scale
Time frame: 14 weeks
Mini Mental Test
Time frame: 14 weeks
Stroop Test
Time frame: 14 weeks
Object Flip Test
Time frame: 14 weeks
Vocabulary Fluency Test
Time frame: 14 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Background: PubMed 36116773Hachenberger 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.
- Background: PubMed 37332295Zhang 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.
- Background: PubMed 32594475Emek 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.
- Background: PubMed 36673880Figueira 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.
- Background: PubMed 27630404Kim 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.
- Background: PubMed 36513380Fu 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.
- BackgroundTerrés 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bapne and qi gong in people with Biomechanics, Anatomy, Psychology, Neuroscience, Ethnomusicology Method and qi Gong, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ithaki Fall Risk Questionnaire (time frame: 14 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06106217, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.