Healthy Elderly IndividualsNCT06924138
Investigation of the Effect of Functional Respiratory Muscle Training on Functional Level, Balance and Biochemical Parameters in Elderly Individuals.
A study testing Exercise and Standart therapy in people with Healthy Elderly Individuals, run by Istanbul Arel University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this thesis study is to investigate the effects of functional respiratory muscle training on functional level, balance, postural control and biochemical parameters in elderly individuals. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Elderly Individuals
- What is being tested?
- Exercise and Standart therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Feb 2025to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Being over 65 years of age.
- No cardiopulmonary problems that prevent exercise
- No orthopedic problems that prevent exercise
Who cannot join
- Being under 65 years of age.
- Presence of cardiopulmonary problems that prevent exercise
- Presence of orthopedic problems that prevent exercise
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Arel University
Istanbul, Zeytinburnu, 34010
About this study
The aim of this thesis study is to investigate the effects of functional respiratory muscle training on functional level, balance, postural control and biochemical parameters in elderly individuals.
H0 hypothesis: Functional respiratory muscle training has no effect on functional level, balance, postural control and biochemical parameters in elderly individuals.
Read more
H1 hypothesis: Functional respiratory muscle training has an effect on functional level, balance, postural control and biochemical parameters in elderly individuals.
The patients included in the study will be randomly divided into two groups as study and control groups. Randomization will be provided by computer-aided program. The patients in the study and control groups will be evaluated at the beginning and after six weeks.
Functional Respiratory Muscle Training will be given to the study group with the Powerbreathe Respironics® (UK) device. The initial training intensity will be set as 50% (threshold loading) of the MIP value measured in the patient's first evaluation. The patient will be re-evaluated and the new MIP value will be measured, increasing by 10% every 2 weeks, and the training intensity will be adjusted by calculating the measured MIP value. Patients will be asked to work four days a week until the exercise sets are completed.
In the control group, the same balance exercises will be performed and will not be changed for six weeks.
Read the detailed description
When the current literature is examined, it is seen that the relationship between respiration and balance is also exercise applications performed together with inspiratory muscle training. On the other hand, the investigators also come across the effects of different exercises on different biochemical parameters.
However, there is no literature information regarding the parameters that the investigators will evaluate together with functional respiratory muscle training. In addition, although there is no study examining the relationship between functional respiratory muscle training and biochemical parameters, balance, and functional level, the relationship between functional respiratory muscle training and oxidative stress level as a biophysiological acute response and thus changes in endometrial nitric oxide and lactate levels is a significant research topic in the literature. The fact that our study includes a functional respiratory exercise application increases the importance of the study. For this reason, the investigators think that such a study is needed in the literature.
The investigators also hope to contribute to the literature by examining the relationship between functional respiratory muscle training in the elderly population and functional level, balance, and biochemical parameters in our study.
With the functional respiratory muscle training that the investigators will apply for 60 minutes 4 days a week, the investigators expect to protect and maximize the functional level of the patient and the pulmonary dysfunctions, dyspnea symptoms, loss of function that may develop due to peripheral and respiratory muscle weakness in the participants; and as a result, the investigators expect to increase the quality of life. With the study the investigators have determined, the investigators think that the investigators will create a protective preventive exercise protocol to prevent functional losses seen with aging, and at the same time, the investigators will determine the biological infrastructure of the problems encountered and reveal different systematic connections for this. In this way, the investigators aim to both pioneer new studies to be conducted in the literature and contribute to the society and public health by producing scientific data to be used in treatment by clinicians.
- Conditions
- Healthy Elderly Individuals
- Being tested
- Exercise, Standart therapy
- Keywords
- functional respiratory muscle training, balance, elderly, oxidative stress, nitric oxide, lactate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
The patients included in the study will be randomly divided into two groups as the study and control groups. Randomization will be provided by a computer-aided program. The patients in the study and control groups will be evaluated at the beginning and after six weeks. Functional Respiratory Muscle Training will be given to the study group with the Powerbreathe Respironics® (UK) device. The initial training intensity will be set at 50% (threshold loading) of the MIP value measured in the patient's first evaluation. The patient will be re-evaluated and the new MIP value will be measured, increasing by 10% every 2 weeks, and the training intensity will be adjusted by calculating the measured MIP value. Patients will be asked to work four days a week until the exercise sets are completed.
Standart therapyOther
In the control group, the same balance exercises will be performed and will not be changed for six weeks.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Not described Receives: Other: Standart therapy |
| intervention group | Experimental | Not described Receives: Other: Exercise; Other: Standart therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiopulmonary exercise test
Cardiopulmonary exercise testing (CPET) has become an invaluable tool in healthcare, improving disease diagnosis and the quality, efficacy, assessment and safety of treatment in a range of pathologies. The superior ability of CPET to measure the global exercise response of the respiratory, cardiovascular and skeletal muscle systems simultaneously and cost-effectively has led to its application in a variety of settings, from disease diagnosis to preoperative evaluation. In our study, CPET will be applied to assess functional exercise capacity.
Measured: Baseline and 6 weeks
Functional Reach Test
It is a special test that evaluates dynamic balance. The person stands with their feet parallel to a wall. A measuring rod is attached to the wall at shoulder height. The person is asked to lift their arm so that the shoulder is in 90° flexion. The tester marks the patient's fingertip position on the measuring rod. The person is asked to reach forward. The distance reached without losing balance is recorded. While this distance is 45-50 cm on average in healthy people, this distance is shortened in those with balance problems. In the extended version of this test, the anterior, posterior and both lateral directions are measured.
Measured: Baseline and 6 weeks
Functional Reach Test Under Load
The test is defined as the maximum distance that the individual can reach forward in the horizontal plane while maintaining stability on the support surface in the standing position. The patient stands with the arm flexed at 90 degrees and the fist closed, without touching the wall but close to it. The assessor marks the head of the 3rd metacarpal on the wall and the patient is asked to reach forward as far as he can without taking a step, holding a weight with his hands that will be 5% of his body weight. The assessor marks the head of the third metacarpal on the wall again and the difference between the beginning and the end is measured with a tape measure. Three trials are performed and the average of these trials is taken. These tests have been stated as valid and reliable tests for postural control and stability.
Measured: Baseline and 6 weeks
Prone Modified Bridge Test
The participant lies face down with his hands and feet shoulder width apart. The participant is then asked to raise his body off the ground by rising on his hands, forearms and knees. The stopwatch is started. If there is any deterioration in position, the stopwatch is stopped and the test is terminated. The elapsed time is recorded in seconds.
Measured: Baseline and 6 weeks
Flamingo Balance Test
The person stands upright with their hands at waist level. They are asked to lift one foot and place it on the knee of the other leg. The time it takes to stand on one foot without losing balance with their eyes closed is recorded.
Measured: Baseline and 6 weeks
Evaluation of the lumbar multifidus and transversus abdominus muscles
Assessment of Muscles with Stabilizer:
The Stabilizer Pressure Biofeedback Unit (PBU) will be used to assess the lumbar multifidus and transversus abdominus muscles. The device consists of a three-chambered, air-filled pressure pad, a thin tube carrying the air, and a pressure gauge indicator. The pressure change in the device is reflected to the indicator by the pressure gauge indicator during position or movement change. The device is placed under the lumbar vertebrae in the supine position with the knees flexed and the manometer pressure is set to 40 mmHg. The participant is asked to hold the pressure at this level by contracting the abdominal wall and the time it takes until the deterioration occurs is recorded in seconds.
Measured: Baseline and 6 weeks
MIP Measurement
The maximum inspiratory muscle strength (MIP) of the individuals will be measured using an intraoral pressure measuring device (Microrpm). Intraoral pressure measurement for MIP values has been reported as a valid and reliable method of assessing respiratory functions within the scope of the American Thoracic Society/European Respiratory Society (ATS/ERS) protocol. During the MIP measurement, the individual is asked to make a maximum expiration and then a maximal inspiration with a nose clip and maintain this for 1-3 seconds.
Measured: Baseline and 6 weeks
MEP Measurement
The maximum expiratory muscle strength (MEP) of the individuals will be measured using an intraoral pressure measuring device (Microrpm). Intraoral pressure measurement for MEP values has been reported as a valid and reliable method of assessing respiratory functions within the scope of the American Thoracic Society/European Respiratory Society (ATS/ERS) protocol. During the MEP measurement, the individual is asked to make a maximum expiration and then a maximal inspiration with a nose clip and maintain this for 1-3 seconds.
Measured: Baseline and 6 weeks
Total Antioxidant Capacity
Inflammation, nutrients, normal metabolism, spreading, aging, high oxygen pressure (pO2), ozone (O3), nitrogen dioxide (NO2), chemical substances, cigarettes and storage of many stimuli such as storage, molecules called oxidants emerge. These oxidant molecules are called free radicals or reactive oxygen species (ROS).
Oxidants: can damage all important images such as lipid, protein, DNA, resolution and enzyme; they can lead to dozens of important problems such as cancer, heart diseases, shoot diseases, structural disorders in the vessels and premature aging.
Measured: Baseline and 6 weeks
Total Oxidant Level
The oxidants in the sample oxidize the ferrous ion-o-dianisidine complex to ferric ion. The glycerol in the medium accelerates this reaction by approximately three-fold. Ferric ions form a colored complex with xylenol orange in an acidic medium. The intensity of the color, which is related to the amount of oxidants in the sample, is measured spectrophotometrically.
At the time of the study, the samples previously stored at -80 ºC will be brought to room temperature.
- 15 µl of the standard and samples will be taken and pipetted into the microplate.
Measured: Baseline and 6 weeks
Measurement of Endothelial Nitric Oxide levels
During the experimental phase, samples will be thawed and lactate and eNOS levels in the samples will be measured by a commercial ELISA-based kit. Briefly; samples and standards will be added to appropriate wells pre-coated with Anti-Human monoclonal antibody before incubation. Then, after biotin is added to all wells and combined with Streptavidin-HRP to form immune complex, the plate will be left for incubation. Uncombined enzyme will be removed by washing processes, then Chromogen Solution A and B will be added sequentially to turn the color of the liquid in the wells blue. At the end of the reaction, the color will be yellow due to the effect of acid. Optical density will be read at 450 nm in a plate reader (Thermo Scientific Microplate Reader, USA).
Measured: Baseline and 6 weeks
Measurement of Lactate levels
During the experimental phase, samples will be thawed and lactate and eNOS levels in the samples will be measured by a commercial ELISA-based kit. Briefly; samples and standards will be added to appropriate wells pre-coated with Anti-Human monoclonal antibody before incubation. Then, after biotin is added to all wells and combined with Streptavidin-HRP to form immune complex, the plate will be left for incubation. Uncombined enzyme will be removed by washing processes, then Chromogen Solution A and B will be added sequentially to turn the color of the liquid in the wells blue. At the end of the reaction, the color will be yellow due to the effect of acid. Optical density will be read at 450 nm in a plate reader (Thermo Scientific Microplate Reader, USA).
Measured: Baseline and 6 weeks
Berg Balance Scale
It has 14 stages including sitting without support, transition from sitting to standing, standing without support, standing with eyes closed, standing with feet together, reaching forward, picking up an object on the floor, turning and looking over the right and left shoulders, turning 360◦, touching the step alternatively, heel/toe, standing on one leg, transitioning from standing to sitting, and transfers. The tester observes the patient during the activity and gives scores between 0 and 4.
Measured: Baseline and 6 weeks
Tinetti Balance Performance Evaluation
It is a screening test used to evaluate balance and walking status. The balance section of the test is scored out of 16 points and the walking section is scored out of 12 points, for a maximum of 28 points. Performance is evaluated during sitting without support, standing up from sitting, coming to sitting from standing, standing without support, standing with eyes closed, turning 360 degrees, and sternal thrust.
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start25 Feb 2025
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Healthy Elderly IndividualsStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Arel University
- Sponsor type
- University, hospital or other
- Collaborators
- Istinye University
- Responsible party
- Principal investigator, Recep Enes Çelik, Istanbul Arel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06924138
- Sponsor's protocol ID
- IstinyeU
- Status last verified
- Mar 2025
- First submitted
- 21 Mar 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dimitriadis Z, Kapreli E, Konstantinidou I, Oldham J, Strimpakos N. Test/retest reliability of maximum mouth pressure measurements with the MicroRPM in healthy volunteers. Respir Care. 2011 Jun;56(6):776-82. doi: 10.4187/respcare.00783. Epub 2011 Feb 9.
PubMed 21310113Ceylan, E. (2014). Kardiyopulmoner egzersiz testleri. Journal of Clinical and Experimental Investigations, 5(3), 504-509.
Morales CR, Sanz DR, Reguera MC, Martinez SF, Gonzalez PT, Pascual BM. Proprioceptive Stabilizer training of the abdominal wall muscles in healthy subjects: a quasi-experimental study. Rev Assoc Med Bras (1992). 2018 Dec;64(12):1134-1138. doi: 10.1590/1806-9282.64.12.1134.
PubMed 30569991Leelarungrayub J, Puntumetakul R, Sriboonreung T, Pothasak Y, Klaphajone J. Preliminary study: comparative effects of lung volume therapy between slow and fast deep-breathing techniques on pulmonary function, respiratory muscle strength, oxidative stress, cytokines, 6-minute walking distance, and quality of life in persons with COPD. Int J Chron Obstruct Pulmon Dis. 2018 Dec 5;13:3909-3921. doi: 10.2147/COPD.S181428. eCollection 2018.
PubMed 30584292van Helvoort HA, van de Pol MH, Heijdra YF, Dekhuijzen PN. Systemic inflammatory response to exhaustive exercise in patients with chronic obstructive pulmonary disease. Respir Med. 2005 Dec;99(12):1555-67. doi: 10.1016/j.rmed.2005.03.028.
PubMed 15890510Heidari B. The importance of C-reactive protein and other inflammatory markers in patients with chronic obstructive pulmonary disease. Caspian J Intern Med. 2012 Spring;3(2):428-35.
PubMed 24358439ben Anes A, Fetoui H, Bchir S, ben Nasr H, Chahdoura H, Chabchoub E, Yacoub S, Garrouch A, Benzarti M, Tabka Z, Chahed K. Increased oxidative stress and altered levels of nitric oxide and peroxynitrite in Tunisian patients with chronic obstructive pulmonary disease: correlation with disease severity and airflow obstruction. Biol Trace Elem Res. 2014 Oct;161(1):20-31. doi: 10.1007/s12011-014-0087-4. Epub 2014 Jul 31.
PubMed 25074430McConnell AK. The role of inspiratory muscle function and training in the genesis of dyspnoea in asthma and COPD. Prim Care Respir J. 2005 Aug;14(4):186-94. doi: 10.1016/j.pcrj.2005.03.008. Epub 2005 Jun 27.
PubMed 16701724Archiza B, Andaku DK, Caruso FCR, Bonjorno JC Jr, Oliveira CR, Ricci PA, Amaral ACD, Mattiello SM, Libardi CA, Phillips SA, Arena R, Borghi-Silva A. Effects of inspiratory muscle training in professional women football players: a randomized sham-controlled trial. J Sports Sci. 2018 Apr;36(7):771-780. doi: 10.1080/02640414.2017.1340659. Epub 2017 Jun 16.
PubMed 28622081Rivara MB, Yeung CK, Robinson-Cohen C, Phillips BR, Ruzinski J, Rock D, Linke L, Shen DD, Ikizler TA, Himmelfarb J. Effect of Coenzyme Q10 on Biomarkers of Oxidative Stress and Cardiac Function in Hemodialysis Patients: The CoQ10 Biomarker Trial. Am J Kidney Dis. 2017 Mar;69(3):389-399. doi: 10.1053/j.ajkd.2016.08.041. Epub 2016 Dec 4.
PubMed 27927588Eickhoff P, Valipour A, Kiss D, Schreder M, Cekici L, Geyer K, Kohansal R, Burghuber OC. Determinants of systemic vascular function in patients with stable chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2008 Dec 15;178(12):1211-8. doi: 10.1164/rccm.200709-1412OC. Epub 2008 Oct 3.
PubMed 18836149Campos NG, Marizeiro DF, Florencio ACL, Silva IC, Meneses GC, Bezerra GF, Martins AMC, Liborio AB. Effects of respiratory muscle training on endothelium and oxidative stress biomarkers in hemodialysis patients: A randomized clinical trial. Respir Med. 2018 Jan;134:103-109. doi: 10.1016/j.rmed.2017.12.005. Epub 2017 Dec 7.
PubMed 29413495Tong TK, McConnell AK, Lin H, Nie J, Zhang H, Wang J. "Functional" Inspiratory and Core Muscle Training Enhances Running Performance and Economy. J Strength Cond Res. 2016 Oct;30(10):2942-51. doi: 10.1519/JSC.0000000000000656.
PubMed 25162653Zunner BEM, Wachsmuth NB, Eckstein ML, Scherl L, Schierbauer JR, Haupt S, Stumpf C, Reusch L, Moser O. Myokines and Resistance Training: A Narrative Review. Int J Mol Sci. 2022 Mar 23;23(7):3501. doi: 10.3390/ijms23073501.
PubMed 35408868Tounsi B, Acheche A, Lelard T, Tabka Z, Trabelsi Y, Ahmaidi S. Effects of specific inspiratory muscle training combined with whole-body endurance training program on balance in COPD patients: Randomized controlled trial. PLoS One. 2021 Sep 23;16(9):e0257595. doi: 10.1371/journal.pone.0257595. eCollection 2021.
PubMed 34555068
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Functional Respiratory Muscle Training on Functional Level, Balance and Biochemical Parameters in Elderly Individuals.
- ClinicalTrials.gov ID
- NCT06924138
- Acronym / sponsor ID
- IstinyeU
- Conditions
- Healthy Elderly Individuals
- Keywords
- functional respiratory muscle training, balance, elderly, oxidative stress, nitric oxide, lactate
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Istanbul Arel UniversityUniversity, hospital or other
- Collaborators
- Istinye University
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 11 Apr 2025 (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.
The aim of this thesis study is to investigate the effects of functional respiratory muscle training on functional level, balance, postural control and biochemical parameters in elderly individuals.
H0 hypothesis: Functional respiratory muscle training has no effect on functional level, balance, postural control and biochemical parameters in elderly individuals.
H1 hypothesis: Functional respiratory muscle training has an effect on functional level, balance, postural control and biochemical parameters in elderly individuals.
The patients included in the study will be randomly divided into two groups as study and control groups. Randomization will be provided by computer-aided program. The patients in the study and control groups will be evaluated at the beginning and after six weeks.
Functional Respiratory Muscle Training will be given to the study group with the Powerbreathe Respironics® (UK) device. The initial training intensity will be set as 50% (threshold loading) of the MIP value measured in the patient's first evaluation. The patient will be re-evaluated and the new MIP value will be measured, increasing by 10% every 2 weeks, and the training intensity will be adjusted by calculating the measured MIP value. Patients will be asked to work four days a week until the exercise sets are completed.
In the control group, the same balance exercises will be performed and will not be changed for six weeks.
Detailed description
When the current literature is examined, it is seen that the relationship between respiration and balance is also exercise applications performed together with inspiratory muscle training. On the other hand, the investigators also come across the effects of different exercises on different biochemical parameters.
However, there is no literature information regarding the parameters that the investigators will evaluate together with functional respiratory muscle training. In addition, although there is no study examining the relationship between functional respiratory muscle training and biochemical parameters, balance, and functional level, the relationship between functional respiratory muscle training and oxidative stress level as a biophysiological acute response and thus changes in endometrial nitric oxide and lactate levels is a significant research topic in the literature. The fact that our study includes a functional respiratory exercise application increases the importance of the study. For this reason, the investigators think that such a study is needed in the literature.
The investigators also hope to contribute to the literature by examining the relationship between functional respiratory muscle training in the elderly population and functional level, balance, and biochemical parameters in our study.
With the functional respiratory muscle training that the investigators will apply for 60 minutes 4 days a week, the investigators expect to protect and maximize the functional level of the patient and the pulmonary dysfunctions, dyspnea symptoms, loss of function that may develop due to peripheral and respiratory muscle weakness in the participants; and as a result, the investigators expect to increase the quality of life. With the study the investigators have determined, the investigators think that the investigators will create a protective preventive exercise protocol to prevent functional losses seen with aging, and at the same time, the investigators will determine the biological infrastructure of the problems encountered and reveal different systematic connections for this. In this way, the investigators aim to both pioneer new studies to be conducted in the literature and contribute to the society and public health by producing scientific data to be used in treatment by clinicians.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: Standart therapy |
| intervention group | Experimental | Other: Exercise, Other: Standart therapy |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Being over 65 years of age.
- No cardiopulmonary problems that prevent exercise
- No orthopedic problems that prevent exercise
Key exclusion criteria (3 listed)
- Being under 65 years of age.
- Presence of cardiopulmonary problems that prevent exercise
- Presence of orthopedic problems that prevent 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 |
|---|---|---|
| ExerciseThe patients included in the study will be randomly divided into two groups as the study and control groups. Randomization will be provided by a computer-aided program. The patients in the study and control groups will be evaluated at the beginning and after six weeks. Functional Respiratory Muscle Training will be given to the study group with the Powerbreathe Respironics® (UK) device. The initial training intensity will be set at 50% (threshold loading) of the MIP value measured in the patient's first evaluation. The patient will be re-evaluated and the new MIP value will be measured, increasing by 10% every 2 weeks, and the training intensity will be adjusted by calculating the measured MIP value. Patients will be asked to work four days a week until the exercise sets are completed. | Other | intervention group |
| Standart therapyIn the control group, the same balance exercises will be performed and will not be changed for six weeks. | Other | control group, intervention group |
Primary outcome
Cardiopulmonary exercise test
Time frame: Baseline and 6 weeks
Cardiopulmonary exercise testing (CPET) has become an invaluable tool in healthcare, improving disease diagnosis and the quality, efficacy, assessment and safety of treatment in a range of pathologies. The superior ability of CPET to measure the global exercise response of the respiratory, cardiovascular and skeletal muscle systems simultaneously and cost-effectively has led to its application in a variety of settings, from disease diagnosis to preoperative evaluation. In our study, CPET will be applied to assess functional exercise capacity.
Functional Reach Test
Time frame: Baseline and 6 weeks
It is a special test that evaluates dynamic balance. The person stands with their feet parallel to a wall. A measuring rod is attached to the wall at shoulder height. The person is asked to lift their arm so that the shoulder is in 90° flexion. The tester marks the patient's fingertip position on the measuring rod. The person is asked to reach forward. The distance reached without losing balance is recorded. While this distance is 45-50 cm on average in healthy people, this distance is shortened in those with balance problems. In the extended version of this test, the anterior, posterior and both lateral directions are measured.
Functional Reach Test Under Load
Time frame: Baseline and 6 weeks
The test is defined as the maximum distance that the individual can reach forward in the horizontal plane while maintaining stability on the support surface in the standing position. The patient stands with the arm flexed at 90 degrees and the fist closed, without touching the wall but close to it. The assessor marks the head of the 3rd metacarpal on the wall and the patient is asked to reach forward as far as he can without taking a step, holding a weight with his hands that will be 5% of his body weight. The assessor marks the head of the third metacarpal on the wall again and the difference between the beginning and the end is measured with a tape measure. Three trials are performed and the average of these trials is taken. These tests have been stated as valid and reliable tests for postural control and stability.
Prone Modified Bridge Test
Time frame: Baseline and 6 weeks
The participant lies face down with his hands and feet shoulder width apart. The participant is then asked to raise his body off the ground by rising on his hands, forearms and knees. The stopwatch is started. If there is any deterioration in position, the stopwatch is stopped and the test is terminated. The elapsed time is recorded in seconds.
Flamingo Balance Test
Time frame: Baseline and 6 weeks
The person stands upright with their hands at waist level. They are asked to lift one foot and place it on the knee of the other leg. The time it takes to stand on one foot without losing balance with their eyes closed is recorded.
Evaluation of the lumbar multifidus and transversus abdominus muscles
Time frame: Baseline and 6 weeks
Assessment of Muscles with Stabilizer: The Stabilizer Pressure Biofeedback Unit (PBU) will be used to assess the lumbar multifidus and transversus abdominus muscles. The device consists of a three-chambered, air-filled pressure pad, a thin tube carrying the air, and a pressure gauge indicator. The pressure change in the device is reflected to the indicator by the pressure gauge indicator during position or movement change. The device is placed under the lumbar vertebrae in the supine position with the knees flexed and the manometer pressure is set to 40 mmHg. The participant is asked to hold the pressure at this level by contracting the abdominal wall and the time it takes until the deterioration occurs is recorded in seconds.
MIP Measurement
Time frame: Baseline and 6 weeks
The maximum inspiratory muscle strength (MIP) of the individuals will be measured using an intraoral pressure measuring device (Microrpm). Intraoral pressure measurement for MIP values has been reported as a valid and reliable method of assessing respiratory functions within the scope of the American Thoracic Society/European Respiratory Society (ATS/ERS) protocol. During the MIP measurement, the individual is asked to make a maximum expiration and then a maximal inspiration with a nose clip and maintain this for 1-3 seconds.
MEP Measurement
Time frame: Baseline and 6 weeks
The maximum expiratory muscle strength (MEP) of the individuals will be measured using an intraoral pressure measuring device (Microrpm). Intraoral pressure measurement for MEP values has been reported as a valid and reliable method of assessing respiratory functions within the scope of the American Thoracic Society/European Respiratory Society (ATS/ERS) protocol. During the MEP measurement, the individual is asked to make a maximum expiration and then a maximal inspiration with a nose clip and maintain this for 1-3 seconds.
Total Antioxidant Capacity
Time frame: Baseline and 6 weeks
Inflammation, nutrients, normal metabolism, spreading, aging, high oxygen pressure (pO2), ozone (O3), nitrogen dioxide (NO2), chemical substances, cigarettes and storage of many stimuli such as storage, molecules called oxidants emerge. These oxidant molecules are called free radicals or reactive oxygen species (ROS). Oxidants: can damage all important images such as lipid, protein, DNA, resolution and enzyme; they can lead to dozens of important problems such as cancer, heart diseases, shoot diseases, structural disorders in the vessels and premature aging.
Total Oxidant Level
Time frame: Baseline and 6 weeks
The oxidants in the sample oxidize the ferrous ion-o-dianisidine complex to ferric ion. The glycerol in the medium accelerates this reaction by approximately three-fold. Ferric ions form a colored complex with xylenol orange in an acidic medium. The intensity of the color, which is related to the amount of oxidants in the sample, is measured spectrophotometrically. At the time of the study, the samples previously stored at -80 ºC will be brought to room temperature. - 15 µl of the standard and samples will be taken and pipetted into the microplate.
Measurement of Endothelial Nitric Oxide levels
Time frame: Baseline and 6 weeks
During the experimental phase, samples will be thawed and lactate and eNOS levels in the samples will be measured by a commercial ELISA-based kit. Briefly; samples and standards will be added to appropriate wells pre-coated with Anti-Human monoclonal antibody before incubation. Then, after biotin is added to all wells and combined with Streptavidin-HRP to form immune complex, the plate will be left for incubation. Uncombined enzyme will be removed by washing processes, then Chromogen Solution A and B will be added sequentially to turn the color of the liquid in the wells blue. At the end of the reaction, the color will be yellow due to the effect of acid. Optical density will be read at 450 nm in a plate reader (Thermo Scientific Microplate Reader, USA).
Measurement of Lactate levels
Time frame: Baseline and 6 weeks
During the experimental phase, samples will be thawed and lactate and eNOS levels in the samples will be measured by a commercial ELISA-based kit. Briefly; samples and standards will be added to appropriate wells pre-coated with Anti-Human monoclonal antibody before incubation. Then, after biotin is added to all wells and combined with Streptavidin-HRP to form immune complex, the plate will be left for incubation. Uncombined enzyme will be removed by washing processes, then Chromogen Solution A and B will be added sequentially to turn the color of the liquid in the wells blue. At the end of the reaction, the color will be yellow due to the effect of acid. Optical density will be read at 450 nm in a plate reader (Thermo Scientific Microplate Reader, USA).
Berg Balance Scale
Time frame: Baseline and 6 weeks
It has 14 stages including sitting without support, transition from sitting to standing, standing without support, standing with eyes closed, standing with feet together, reaching forward, picking up an object on the floor, turning and looking over the right and left shoulders, turning 360◦, touching the step alternatively, heel/toe, standing on one leg, transitioning from standing to sitting, and transfers. The tester observes the patient during the activity and gives scores between 0 and 4.
Tinetti Balance Performance Evaluation
Time frame: Baseline and 6 weeks
It is a screening test used to evaluate balance and walking status. The balance section of the test is scored out of 16 points and the walking section is scored out of 12 points, for a maximum of 28 points. Performance is evaluated during sitting without support, standing up from sitting, coming to sitting from standing, standing without support, standing with eyes closed, turning 360 degrees, and sternal thrust.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Results publication: PubMed 21310113Dimitriadis Z, Kapreli E, Konstantinidou I, Oldham J, Strimpakos N. Test/retest reliability of maximum mouth pressure measurements with the MicroRPM in healthy volunteers. Respir Care. 2011 Jun;56(6):776-82. doi: 10.4187/respcare.00783. Epub 2011 Feb 9.
- Results publicationCeylan, E. (2014). Kardiyopulmoner egzersiz testleri. Journal of Clinical and Experimental Investigations, 5(3), 504-509.
- Results publication: PubMed 30569991Morales CR, Sanz DR, Reguera MC, Martinez SF, Gonzalez PT, Pascual BM. Proprioceptive Stabilizer training of the abdominal wall muscles in healthy subjects: a quasi-experimental study. Rev Assoc Med Bras (1992). 2018 Dec;64(12):1134-1138. doi: 10.1590/1806-9282.64.12.1134.
- Results publication: PubMed 30584292Leelarungrayub J, Puntumetakul R, Sriboonreung T, Pothasak Y, Klaphajone J. Preliminary study: comparative effects of lung volume therapy between slow and fast deep-breathing techniques on pulmonary function, respiratory muscle strength, oxidative stress, cytokines, 6-minute walking distance, and quality of life in persons with COPD. Int J Chron Obstruct Pulmon Dis. 2018 Dec 5;13:3909-3921. doi: 10.2147/COPD.S181428. eCollection 2018.
- Results publication: PubMed 15890510van Helvoort HA, van de Pol MH, Heijdra YF, Dekhuijzen PN. Systemic inflammatory response to exhaustive exercise in patients with chronic obstructive pulmonary disease. Respir Med. 2005 Dec;99(12):1555-67. doi: 10.1016/j.rmed.2005.03.028.
- Results publication: PubMed 24358439Heidari B. The importance of C-reactive protein and other inflammatory markers in patients with chronic obstructive pulmonary disease. Caspian J Intern Med. 2012 Spring;3(2):428-35.
- Results publication: PubMed 25074430ben Anes A, Fetoui H, Bchir S, ben Nasr H, Chahdoura H, Chabchoub E, Yacoub S, Garrouch A, Benzarti M, Tabka Z, Chahed K. Increased oxidative stress and altered levels of nitric oxide and peroxynitrite in Tunisian patients with chronic obstructive pulmonary disease: correlation with disease severity and airflow obstruction. Biol Trace Elem Res. 2014 Oct;161(1):20-31. doi: 10.1007/s12011-014-0087-4. Epub 2014 Jul 31.
- Results publication: PubMed 16701724McConnell AK. The role of inspiratory muscle function and training in the genesis of dyspnoea in asthma and COPD. Prim Care Respir J. 2005 Aug;14(4):186-94. doi: 10.1016/j.pcrj.2005.03.008. Epub 2005 Jun 27.
- Results publication: PubMed 28622081Archiza B, Andaku DK, Caruso FCR, Bonjorno JC Jr, Oliveira CR, Ricci PA, Amaral ACD, Mattiello SM, Libardi CA, Phillips SA, Arena R, Borghi-Silva A. Effects of inspiratory muscle training in professional women football players: a randomized sham-controlled trial. J Sports Sci. 2018 Apr;36(7):771-780. doi: 10.1080/02640414.2017.1340659. Epub 2017 Jun 16.
- Results publication: PubMed 27927588Rivara MB, Yeung CK, Robinson-Cohen C, Phillips BR, Ruzinski J, Rock D, Linke L, Shen DD, Ikizler TA, Himmelfarb J. Effect of Coenzyme Q10 on Biomarkers of Oxidative Stress and Cardiac Function in Hemodialysis Patients: The CoQ10 Biomarker Trial. Am J Kidney Dis. 2017 Mar;69(3):389-399. doi: 10.1053/j.ajkd.2016.08.041. Epub 2016 Dec 4.
- Results publication: PubMed 18836149Eickhoff P, Valipour A, Kiss D, Schreder M, Cekici L, Geyer K, Kohansal R, Burghuber OC. Determinants of systemic vascular function in patients with stable chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2008 Dec 15;178(12):1211-8. doi: 10.1164/rccm.200709-1412OC. Epub 2008 Oct 3.
- Results publication: PubMed 29413495Campos NG, Marizeiro DF, Florencio ACL, Silva IC, Meneses GC, Bezerra GF, Martins AMC, Liborio AB. Effects of respiratory muscle training on endothelium and oxidative stress biomarkers in hemodialysis patients: A randomized clinical trial. Respir Med. 2018 Jan;134:103-109. doi: 10.1016/j.rmed.2017.12.005. Epub 2017 Dec 7.
- Individual participant dataSharing planned: No
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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 Exercise and Standart therapy in people with Healthy Elderly Individuals, run by Istanbul Arel University 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: under way, not looking for participants, as of the sponsor's last update on 8 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Cardiopulmonary exercise test (time frame: Baseline and 6 weeks). The study lists 14 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 NCT06924138, which also lists 21 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 8 Sep 2025.