Investigation of the Effect of Functional Respiratory Muscle Training on Functional Level, Balance and Biochemical Parameters in Elderly Individuals.

August 31, 2025 updated by: Recep Enes Çelik, Istanbul Arel University

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

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

  • Turkey (Türkiye)
    • Zeytinburnu
      • Istanbul, Zeytinburnu, Turkey (Türkiye), 34010
        • Istanbul Arel University

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

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control group
Other: Standart therapy
In the control group, the same balance exercises will be performed and will not be changed for six weeks.
Experimental: intervention group
Other: Standart therapy
In the control group, the same balance exercises will be performed and will not be changed for six weeks.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 6 weeks
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.
Baseline and 6 weeks
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.
Baseline and 6 weeks
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.
Baseline and 6 weeks
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.
Baseline and 6 weeks
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.
Baseline and 6 weeks
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.
Baseline and 6 weeks
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.
Baseline and 6 weeks
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.
Baseline and 6 weeks
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.
Baseline and 6 weeks
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).
Baseline and 6 weeks
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).
Baseline and 6 weeks
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.
Baseline and 6 weeks
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.
Baseline and 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Arel University

Collaborators

Istinye University

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

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)

February 25, 2025

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

March 21, 2025

First Submitted That Met QC Criteria

April 5, 2025

First Posted (Actual)

April 11, 2025

Study Record Updates

Last Update Posted (Estimated)

September 8, 2025

Last Update Submitted That Met QC Criteria

August 31, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IstinyeU

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

product manufactured in and exported from the U.S.

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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