Investigation of the Effect of Functional Respiratory Muscle Training on Functional Level, Balance and Biochemical Parameters in Elderly Individuals.
NCT ID: NCT06924138
Last Updated: 2025-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
40 participants
INTERVENTIONAL
2025-02-25
2025-11-01
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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control group
Standart therapy
In the control group, the same balance exercises will be performed and will not be changed for six weeks.
intervention group
Exercise
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 therapy
In the control group, the same balance exercises will be performed and will not be changed for six weeks.
Interventions
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Exercise
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 therapy
In the control group, the same balance exercises will be performed and will not be changed for six weeks.
Eligibility Criteria
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Inclusion Criteria
* No cardiopulmonary problems that prevent exercise
* No orthopedic problems that prevent exercise
Exclusion Criteria
* Presence of cardiopulmonary problems that prevent exercise
* Presence of orthopedic problems that prevent exercise
65 Years
ALL
Yes
Sponsors
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Istinye University
OTHER
Istanbul Arel University
OTHER
Responsible Party
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Recep Enes Çelik
Lecturer, Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences
Locations
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Istanbul Arel University
Istanbul, Zeytinburnu, Turkey (Türkiye)
Countries
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References
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ben 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.
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Campos 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.
Tong 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.
Zunner 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.
Tounsi 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.
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Akgül, A., Tarakci, E., Arman, N., Büyükkaya, F., Irmak, H. S., & Karaaslan, T. (2018). Yaşlılarda denge, mobilite ve düşmenin değerlendirilmesi. Türkiye Klinikleri. Tip Bilimleri Dergisi, 38(1), 94-98.
Janssens L, Brumagne S, McConnell AK, Claeys K, Pijnenburg M, Goossens N, Burtin C, Janssens W, Decramer M, Troosters T. Impaired postural control reduces sit-to-stand-to-sit performance in individuals with chronic obstructive pulmonary disease. PLoS One. 2014 Feb 12;9(2):e88247. doi: 10.1371/journal.pone.0088247. eCollection 2014.
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Other Identifiers
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IstinyeU
Identifier Type: -
Identifier Source: org_study_id
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