Clinical trial NCT05668975: The Effects of Inspiratory Muscle Training on Diaphragm Thickness, Inspiratory Muscle Strength and Exercise Capacity in Individuals With Sarcopenia
Official title: The Effects of Inspiratory Muscle Training on Diaphragm Thickness, Inspiratory Muscle Strength and Exercise Capacity in Individuals With Sarcopenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sarcopenia
Keywords: Inspiratory Muscle Training
Diaphragm Thickness
Respiratory Sarcopenia
Sarcopenia
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2022-12-30
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sarcopenia, according to EWGSOP2(European Working Group on Sarcopenia in Older People-2019), is a progressive and generalised skeletal muscle disorder that is associated with increased likelihood of adverse outcomes including falls, fractures, physical disability, and mortality. Changes in muscle strength and muscle mass that occur with aging are not only limited to the skeletal muscles surrounding the axial and appendicular skeleton, but also occur in the respiratory muscles. With aging, respiratory muscle strength decreases, muscle mass decreases, and respiratory functions decline. In sarcopenic individuals; maximum inspiratory pressure (MIP), maximum expiratory pressure (MEP) and diaphragm muscle thickness values were found to be significantly lower.

It is known that exercise is the most effective and valid way to treat sarcopenia. Considering the positive effects of IMT (Inspiratory Muscle Training) on both respiratory and physical parameters in the elderly population, we think that these changes can also be observed in sarcopenic individuals. Therefore, the aim of this study is to investigate the effects of inspiratory muscle training on diaphragm thickness, inspiratory muscle strength, and exercise capacity in sarcopenic individuals.


Eligibility criteria: Inclusion Criteria:

* People who are diagnosed with confirmed sarcopenia or severe sarcopenia according to EWGSOP2 (European Working Group on Sarcopenia in Older People-2019)
* Getting a score of 24 or higher on the mini-mental state test

Exclusion Criteria:

* Presence of chronic lung and/or cardiovascular disease
* Presence of severe orthopedic diseases which may affect participants' mobility
* Presence of uncontrollable hypertension and/or diabetes.

Primary outcomes:
measure: Maximal Inspiratory Pressure
timeFrame: Eight weeks
measure: Diaphragm Thickness Measurement at Quiet Breathing
timeFrame: Eight weeks
measure: Diaphragm Thickness Measurement at Total Lung Capacity (TLC)
timeFrame: Eight weeks
measure: Diaphragm Thickness Measurement at Functional Residual Capacity (FRC)
timeFrame: Eight weeks
measure: Diaphragm Elastography Measurement at Quiet Breathing
timeFrame: Eight weeks
measure: Diaphragm Elastography Measurement at Total Lung Capacity (TLC)
timeFrame: Eight weeks
measure: Diaphragm Elastography Measurement at Functional Residual Capacity (FRC)
timeFrame: Eight weeks
measure: Exercise Capacity Measurement
timeFrame: Eight weeks
Secondary outcomes:
measure: Pulmonary Function Test [Forced Vital Capacity (FVC)]
timeFrame: Eight weeks
measure: Pulmonary Function Test [Forced Expiratory Volume in the first second (FEV1)]
timeFrame: Eight weeks
measure: Pulmonary Function Test [Peak Expiratory Flow Rate (PEFR)]
timeFrame: Eight weeks
measure: Pulmonary Function Test [Forced expiratory flow 25-75 (FEF25-75%)]
timeFrame: Eight weeks
measure: Assesment of Quality of Life
timeFrame: Eight weeks
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: İstanbul Üniversitesi İstanbul Tıp Fakültesi Spor Hekimliği Anabilim Dalı
Study officials:
References:
citation: Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
citation: Ohara DG, Pegorari MS, Oliveira Dos Santos NL, de Fatima Ribeiro Silva C, Monteiro RL, Matos AP, Jamami M. Respiratory Muscle Strength as a Discriminator of Sarcopenia in Community-Dwelling Elderly: A Cross-Sectional Study. J Nutr Health Aging. 2018;22(8):952-958. doi: 10.1007/s12603-018-1079-4.
citation: Deniz O, Coteli S, Karatoprak NB, Pence MC, Varan HD, Kizilarslanoglu MC, Oktar SO, Goker B. Diaphragmatic muscle thickness in older people with and without sarcopenia. Aging Clin Exp Res. 2021 Mar;33(3):573-580. doi: 10.1007/s40520-020-01565-5. Epub 2020 May 13.
citation: Souza H, Rocha T, Pessoa M, Rattes C, Brandao D, Fregonezi G, Campos S, Aliverti A, Dornelas A. Effects of inspiratory muscle training in elderly women on respiratory muscle strength, diaphragm thickness and mobility. J Gerontol A Biol Sci Med Sci. 2014 Dec;69(12):1545-53. doi: 10.1093/gerona/glu182.