Inspiratory Muscle Training on Balance, Falls and Diaphragm Thickness in the Elderly

NCT06143592 | Unknown

• 1 other identifier: Inspiratory Muscle Training
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Decreases in body muscle mass, function and strength occur with ageing and this condition is called "sarcopenia". It is known that sarcopenic elderly people fall more than non-sarcopenic elderly people, their balance is negatively affected, their diaphragm thickness decreases and their quality of life may decrease due to their lower functional capacity. Although exercise training, which is considered among the approaches in the treatment of sarcopenia, has been shown to be an effective method, the effects of inspiratory muscle training applied at different intensities are relatively limited. Therefore, in this study, we are investigating the effects of low \[30% of maximal inspiratory pressure (MIP)\] and moderate (50% of MIP) inspiratory muscle training on respiratory and peripheral muscle strength, physical performance, functional capacity, balance, fear of falling, quality of life, diaphragm thickness and stiffness in sarcopenic elderly. In this study, participants are randomly divided into 3 groups: a low-intensity inspiratory muscle training group, a moderate-intensity inspiratory muscle training group and control (sham) group by simple random method after being evaluated for respiratory and peripheral muscle strength, physical performance, functional capacity, balance, fear of falling, quality of life, diaphragm thickness and stiffness.

Conditions

Sarcopenia

Keywords

falls; exercise; elderly

Outcome Measures

Primary Outcomes (9)

• Respiratory Muscle Strength Assessment

  The easiest and most commonly used method to measure respiratory muscle strength is maximal inspiratory and expiratory pressure measurements. Maximal inspiratory pressure (MIP) indicates inspiratory muscle strength. Maximal expiratory pressure (MEP) reflects expiratory muscle strength. Standard guidelines set by the American Thoracic Society/European Respiratory Society will be followed during the assessments. For the MIP assessment, the participant will be asked to perform a maximal expiration manoeuvre followed by maximal inspiration for 1-3 seconds (Müller manoeuvre). For the MEP assessment, the participant first performs a maximum inspiration manoeuvre, followed by maximum expiration for 1-3 seconds (Valsalva manoeuvre). In our study, measurements will be performed with a mobile and easy-to-use electronic pressure measuring device (MicroRPM, Vyaire Medical, Mettawa, IL).

  at baseline, at week 4, at week 8, at week 12

• Peripheral Muscle Strength Assessment: Hand Grip Strength

  Hand grip strength is a reliable method that provides information about upper extremity muscle strength in elderly participants. A hand dynamometer (Jamar, Fabrication Enterprised Inc., Irvington, New York) will be used in the evaluation. The measurements are made in the test position standardized by the American Association of Hand Therapists with the tested arm sitting upright in an unsupported chair with the shoulder in adduction, elbow in 90º flexion, forearm in neutral position, wrist in 0-30º extension and 0-15º ulnar deviation. During the assessment, the participant is asked to squeeze the dynamometer with all his/her strength and then let his/her hand go completely relaxed. This process is performed three times and the average of these values is recorded in kg/force. In our study, hand grip strength will be measured for both hands.

  at baseline and at the end of 12th week

• Peripheral Muscle Strength Assessment: Knee Extension Strength

  Knee extension strength will be measured with a manual muscle tester (Lafayette Instrument Company, Lafayette, Indiana) in a sitting position with the hip and knee joint in 90° flexion. During the measurement from the distal tibia, the participant is asked to bring the knee to full extension. Each measurement is performed three times and muscle strength is determined by taking the arithmetic mean of the total value. In our study, knee extension strength will be measured for both legs.

  at baseline and at the end of 12th week

• Dynamic Balance Assessment: Mini-Balance Evaluation Systems Test (Mini-BESTest)

  Participants' dynamic balance will be assessed using the Mini BESTest, the short version of BESTest. The questionnaire, which consists of 14 items in total, has 4 sub-items in total, including anticipatory postural control (standing up from a sitting position, standing on tiptoe, standing on one leg), reactive postural control (forward, backward and lateral compensatory corrective stepping), sensory orientation (firm surface with eyes open, foam surface with eyes closed and inclined surface with eyes closed), dynamic gait (change in gait speed, walking with horizontal head movements, pivoting while walking, stepping over obstacles, timed stand and walk with double task). The score of each item ranges from "0" to "2" and the total score ranges from "0" to "28". A high score indicates good balance.

  at baseline and at the end of 12th week

• Diaphragm Thickness and Stiffness Assessment

  Diaphragm thickness and stiffness will be evaluated by the relevant physician using an ultrasound device. The probe will be placed between the anterior and middle axillary lines of the 9th or 10th intercostal spaces while the participant is in the supine position. Assessments will be performed during the peak inspiration and end-expiration phases of the normal respiratory cycle.

  at baseline and at the end of 12th week

• Static Balance Asssesment

  Static balance measurements of participants will be performed with Biodex Balance System® (Biodex Medical Systems, Inc., United States of America). With this balance device, "postural stability", "limits of stability" and "fall risk" of participants are evaluated. All tests will be performed bipedal with bare feet on a standard support surface.

  at baseline and at the end of 12th week

• Static Balance Asssesment: Postural Stability Test

  In this test, participants will be instructed to stand still on the platform and the displacement of the centre of gravity (COG) is quantified for anterior-posterior (AP) and medial-lateral (ML) axes. It gives three types of outcome measures: overall stability index, AP stability index and ML stability index. Higher scores indicate worse postural stability. In our study, the test will be repeated three times for 30 seconds and 10 seconds rest will be given between repetitions.

  at baseline and at the end of 12th week

• Static Balance Asssesment: Limits of Stability Test

  This test tests the participant's ability to control and move the centre of gravity within the limits of the support surface. The difficulty level of the test is "easy", "medium", "difficult". The participant is asked to reach out in a linear fashion by shifting the centre of gravity towards the ball in eight different directions flashing on the screen. This is repeated three times with a 10-second rest between repetitions. Low scores express poor postural control. In our study, the "easy" test will be applied, and the completion time of the test, the percentage score of stability in each direction and the total percentage score will be used in the data analysis of our study.

  at baseline and at the end of 12th week

• Static Balance Asssesment: Modified Balance Sensory Integration Test

  In our study, this test will be used to assess the fall risk of participants. The participant is asked to stand upright with both feet shoulder-width apart and hands at the sides, in the most comfortable position to maintain balance. The test is administered in four different situations: firm surface with eyes open/closed, foam surface with eyes open/closed. The device gives the sway index score of the participant in these four different situations. A higher sway index score indicates increased postural sway. In our study, the test will be repeated three times for 30 seconds and 10 seconds rest will be given between repetitions.

  at baseline and at the end of 12th week

Secondary Outcomes (5)

• Physical Performance Assessment: Timed Get Up and Go Test

  at baseline and at the end of 12th week

• Physical Performance Assessment: Sit up and Stand Test from a Chair

  at baseline and at the end of 12th week

• Functional Capacity Assessment: Six Minute Walk Test

  at baseline and at the end of 12th week

• Fear of Falling Assessment: Falls Efficacy Scale International (FES-I)

  at baseline and at the end of 12th week

• Quality of Life Assessment: Sarcopenia Quality of Life Questionnaire (SarQoL)

  at baseline and at the end of 12th week

Study Arms (3)

Low-Intensity Inspiratory Muscle Training Group (LI-IMT)

EXPERIMENTAL

Before the training, the MIP value is recorded in "cmH2O". The inspiratory muscle training intensity in the first four weeks is determined by taking 30% of the MIP value and the resistance of the device is adjusted to this level. The pressure measurements of the participants are repeated in the 4th week and the new MIP value is determined. Then, 30% of the new MIP value is taken to determine the training intensity in the 4th to 8th week and the resistance of the device is adjusted to this new level. This situation is repeated in the same way in the 8th week and the new training intensity in the 8th to 12th week is determined by taking 30% of the new MIP value. According to the MIP values obtained during the entire training period, participants are asked to work at home for 12 weeks, three to five days a week, 2 times a day, 15-minutes each, 30 minutes total.

Other: Inspiratory Muscle Training

Modarate-Intensity Inspiratory Muscle Training Group (MI-IMT)

EXPERIMENTAL

Before the training, the MIP value is recorded in "cmH2O". The inspiratory muscle training intensity in the first four weeks is determined by taking 50% of the MIP value and the resistance of the device is adjusted to this level. The pressure measurements of the participants are repeated in the 4th week and the new MIP value is determined. Then, 50% of the new MIP value is taken to determine the training intensity in the 4th to 8th week and the resistance of the device is adjusted to this new level. This situation is repeated in the same way in the 8th week and the new training intensity in the 8th to 12th week is determined by taking 50% of the new MIP value. According to the MIP values obtained during the entire training period, participants are asked to work at home for 12 weeks, three to five days a week, 2 times a day, 15-minutes each, 30 minutes total.

Other: Inspiratory Muscle Training

Control Group (Sham Group)

EXPERIMENTAL

Participants in the control group are given a POWERbreathe® device with the resistance set to the lowest level (0 cmH2O) at the end of the session where the initial assessments are made. As in the training group, participants are asked to work at home for 12 weeks, three to five days a week, 2 times a day, 15-minutes each, 30 minutes total. In order to eliminate the learning effect on the participants, pressure measurements are made in the 4th and 8th weeks, but the training intensity is kept constant at the lowest level during the 12 weeks.

Other: Inspiratory Muscle Training

Interventions

Inspiratory Muscle Training OTHER

Inspiratory muscle training is performed using POWERbreathe® (Powerbreathe, POWERbreathe International Ltd.Warwickshire, England) with a working range of 10-90 cmH2O with the inspiratory threshold pressure loading method. The device is given to each participant to use at home, so Gazi University Scientific Research Projects Coordination Unit (BAP) was applied for the supply of the devices. At the end of the session in which the initial evaluations of all participants are made, the participants are told how to work with the device, the resistance levels of the device and the points to be considered during the application. A sample application session is performed with the participants under the supervision of a specialist physiotherapist. Participants are called by the same physiotherapist every two days by phone to ensure their compliance with the training.

Control Group (Sham Group); Low-Intensity Inspiratory Muscle Training Group (LI-IMT); Modarate-Intensity Inspiratory Muscle Training Group (MI-IMT)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• being diagnosed with sarcopenia,
• years of age or older,
• scoring above 21 on the Mini-Mental State Scale,
• volunteering to participate in the study.

You may not qualify if:

• active smoker or quit smoking in less than 5 years,
• undergone abdominal surgery, thoracic surgery or lower extremity surgery,
• fracture within the last 1 year,
• having a condition that prevents bioelectrical impedance measurement such as pacemaker, implant,
• having a disease such as pulmonary artery hypertension, glaucoma, an aneurysm that prevents the Valsalva manoeuvre,
• having hypertension that cannot be controlled with antihypertensive medication,
• having a neurological disease affecting mobility such as cerebrovascular disease, Parkinson's disease,
• having chronic inflammatory disease known to affect muscle metabolism, including uncontrolled diabetes (Hba1c\>9), rheumatoid arthritis,
• presence of any acute and chronic cardiovascular disease such as unstable angina pectoris, recent myocardial infarction, uncontrolled cardiac arrhythmia, congestive heart failure, acute ischemic heart disease,
• presence of any acute and chronic pulmonary disease such as COPD, acute pulmonary embolism, pulmonary oedema,
• having a history of cancer.

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Ankara Dr. Sami Ulus Children Health and Diseases Training and Research Hospital

Ankara, Altındağ/Ankara, 06080, Turkey (Türkiye)

RECRUITING

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MeSH Terms

Conditions

Sarcopenia; Motor Activity

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Behavior

Study Officials

• Selda Başar

  Gazi University

  STUDY DIRECTOR

Central Study Contacts

Ekin Taçalan

CONTACT

+90 0554 204 47 89; ekintacalan@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc, PT

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: November 22, 2023
• Study Start: September 5, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)