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

NCT06924138 | Active Not Recruiting

• 1 other identifier: IstinyeU
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Elderly Individuals

Keywords

functional respiratory muscle training; balance; elderly; oxidative stress; nitric oxide; lactate

Outcome Measures

Primary Outcomes (14)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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).

  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).

  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.

  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.

  Baseline and 6 weeks

Study Arms (2)

control group

ACTIVE COMPARATOR

Other: Standart therapy

intervention group

EXPERIMENTAL

Other: Exercise; Other: Standart therapy

Interventions

Exercise OTHER

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.

intervention group

Standart therapy OTHER

In the control group, the same balance exercises will be performed and will not be changed for six weeks.

control group; intervention group

Eligibility Criteria

• Age: 65 Years+
• Gender Eligibility Details: Male, Female
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul Arel University: lead
• Istinye University: collaborator

Study Sites (1)

Istanbul Arel University

Istanbul, Zeytinburnu, 34010, Turkey (Türkiye)

Location

Related Publications (21)

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MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This study will employ a single-blind design in which participants will be unaware of their group allocation (intervention or control). The intervention and control groups will receive treatments that are identical in appearance and administration procedure to ensure blinding. Investigators will remain unblinded due to the nature of the intervention, which requires close monitoring. This design is intended to minimize bias in participant-reported outcomes and ensure the validity of the findings.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: April 11, 2025
• Study Start: February 25, 2025
• Primary Completion: September 1, 2025
• Study Completion: November 1, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)