Clinical trial NCT06924138: Investigation of the Effect of Functional Respiratory Muscle Training on Functional Level, Balance and Biochemical Parameters in Elderly Individuals.
Official title: Investigation of the Effect of Functional Respiratory Muscle Training on Functional Level, Balance and Biochemical Parameters in Elderly Individuals.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy Elderly Individuals
Keywords: functional respiratory muscle training
balance
elderly
oxidative stress
nitric oxide
lactate
Lead sponsor: Istanbul Arel University
Sponsor class: OTHER
Collaborators: name: Istinye University
First posted: 2025-04-11
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Being over 65 years of age.
* No cardiopulmonary problems that prevent exercise
* No orthopedic problems that prevent exercise

Exclusion Criteria:

* Being under 65 years of age.
* Presence of cardiopulmonary problems that prevent exercise
* Presence of orthopedic problems that prevent exercise

Primary outcomes:
measure: Cardiopulmonary exercise test
timeFrame: Baseline and 6 weeks
measure: Functional Reach Test
timeFrame: Baseline and 6 weeks
measure: Functional Reach Test Under Load
timeFrame: Baseline and 6 weeks
measure: Prone Modified Bridge Test
timeFrame: Baseline and 6 weeks
measure: Flamingo Balance Test
timeFrame: Baseline and 6 weeks
measure: Evaluation of the lumbar multifidus and transversus abdominus muscles
timeFrame: Baseline and 6 weeks
measure: MIP Measurement
timeFrame: Baseline and 6 weeks
measure: MEP Measurement
timeFrame: Baseline and 6 weeks
measure: Total Antioxidant Capacity
timeFrame: Baseline and 6 weeks
measure: Total Oxidant Level
timeFrame: Baseline and 6 weeks
measure: Measurement of Endothelial Nitric Oxide levels
timeFrame: Baseline and 6 weeks
measure: Measurement of Lactate levels
timeFrame: Baseline and 6 weeks
measure: Berg Balance Scale
timeFrame: Baseline and 6 weeks
measure: Tinetti Balance Performance Evaluation
timeFrame: Baseline and 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Arel University
state: Zeytinburnu
Study officials:
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