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SarcopeniaNCT06548984

Respiratory Sarcopenia in Older Adults

A study testing diaphragmatic exercises and Respiratory muscle training in people with Sarcopenia, run by Felipe León Morillas at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The objectives of this study are to describe the prevalence of respiratory sarcopenia, evaluate its pattern of evolution over a one-year follow-up, and determine the response to a therapeutic exercise program in older adults in a geriatric nursing clinic. Read more about this study

Who is it for?
Any age
Conditions the study is for
Sarcopenia
What is being tested?
diaphragmatic exercises and Respiratory muscle training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteSpain
Study dates
1 Sep 2024to 31 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • have functional ambulation (even with technical aids)
  • be able to obey simple commands, such as taking deep breaths
  • have sufficient oral occlusion capacity to perform respiratory tes

Who cannot join

  • presence of acute respiratory diseases
  • serious orthopedic diseases that interfere with measurements
  • diagnosis of severe dementia
  • those who present any contraindication for performing respiratory pressure measurement tests, as established in the guidelines of the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR).

Trial locations and contacts

1 site in 1 country.

Silvana L de Oliveira Sousa, Dr. contact

+34868884201 ext. +34

soliveira@um.es

Carmelo S Gómez Martínez, Dr. contact

csgomez@ucam.edu

Spain1 site

  • Hospital Clinic Virgen de la Arrixaca Ctra. Madrid-Cartagena, s/n, 30120 El Palmar, Murcia

    Murcia, 30120

    Felipe LEÓN MORILLAS, fisioleon.jodar@gmail.com

    Silvana Loana De Oliveira Sousa

Other trials in Spain

About this study

Official title: Respiratory Sarcopenia in Older Adults: Prevalence, Associated Factors and Response to an Exercise Program

The objectives of this study are to describe the prevalence of respiratory sarcopenia, evaluate its pattern of evolution over a one-year follow-up, and determine the response to a therapeutic exercise program in older adults in a geriatric nursing clinic.

A sample of approximately 115 older adults, of both sexes, from the geriatric nursing clinic of the Virgen de la Arrixaca Hospital, Murcia, will participate in the study. In the first stage, a prospective observational study will be carried out, with one year of follow-up, and subsequently a randomized controlled clinical trial, with patients who have been diagnosed with respiratory sarcopenia. In the clinical trial, patients will be divided into 3 groups: control, experimental 1 (diaphragmatic exercises) and experimental 2 (respiratory muscle training). Sociodemographic and clinical variables, physical function (palm grip, 5STS, 4MGS), respiratory function (respiratory muscle strength and diaphragmatic thickness) and health outcomes (respiratory infections, visit to the emergency department, hospitalization, falls, bedridden and/or death). Descriptive statistics, univariate and multivariate logistic regression models, Cox proportional hazards model and Kaplan-Meier curves will be used to analyze the data from the longitudinal study. To compare the differences between pre- and post-intervention of the clinical trial, a two-factor analysis of variance for repeated measures will be used. A P-value <0.05 will be considered significant in all analyses. The recording and analysis of the data will be carried out with the IBM SPSS Statistics 24® program.

Conditions
Sarcopenia
Being tested
diaphragmatic exercises, Respiratory muscle training
Keywords
Sarcopsarcopenia, geriatrics, respiratory function
Medical subject headings
Sarcopenia, Respiratory Aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • diaphragmatic exercisesOther

    Perform controlled and supervised diaphragmatic exercises

  • Respiratory muscle trainingOther

    Perform respiratory muscle training with controlled and supervised devices

Study groups in NCT06548984
Study groupRoleWhat they receive
Experimental group 1Experimentaldiaphragmatic exercises
Receives: Other: diaphragmatic exercises
Experimental group 2ExperimentalRespiratory muscle training
Receives: Other: Respiratory muscle training
Control groupNo interventionNo intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. RESPIRATORY MUSCLE FUNCTION

    INSPIRATORY AND EXPIRATORY PRESSURE OF THE MUSCULATURE

    Measured: 24 Months

  2. ultrasound

    diaphragm muscle thickness

    Measured: 24 Months

  3. physical function hand grip

    Hand grip: palm press strength

    Measured: 24 Months

  4. Physical function

    five times sit-up test (5STS)

    Measured: 24 Months

  5. Physical function walking speed

    walking speed (4MGS)

    Measured: 24 Months

  6. body composition

    Calculation of bioimpedance

    Measured: 24 Months

Secondary outcomes (1)

  1. Sociodemografic

    sex, age, marital status and educational level

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2024
  2. Study start1 Sep 2024 (estimated)
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06548984
Sponsor's protocol ID
SarcoResp_Com
Status last verified
Aug 2024
First submitted
7 Mar 2024
Last updated
12 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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 Jul 1;48(4):601. doi: 10.1093/ageing/afz046. No abstract available.

    PubMed 31081853

  • Beaudart C, Zaaria M, Pasleau F, Reginster JY, Bruyere O. Health Outcomes of Sarcopenia: A Systematic Review and Meta-Analysis. PLoS One. 2017 Jan 17;12(1):e0169548. doi: 10.1371/journal.pone.0169548. eCollection 2017.

    PubMed 28095426

  • Papadopoulou SK, Tsintavis P, Potsaki P, Papandreou D. Differences in the Prevalence of Sarcopenia in Community-Dwelling, Nursing Home and Hospitalized Individuals. A Systematic Review and Meta-Analysis. J Nutr Health Aging. 2020;24(1):83-90. doi: 10.1007/s12603-019-1267-x.

    PubMed 31886813

  • Tovar-Alcaraz A, de Oliveira-Sousa SL, Leon-Garzon MC, Gonzalez-Carrillo MJ. [Effects of inspiratory muscle training on respiratory function and balance in stroke survivors: a randomized controlled trial]. Rev Neurol. 2021 Feb 16;72(4):112-120. doi: 10.33588/rn.7204.2020532. Spanish.

    PubMed 33570158

  • de Oliveira-Sousa SL, Leon-Garzon MC, Gacto-Sanchez M, Ibanez-Vera AJ, Espejo-Antunez L, Leon-Morillas F. Does Inspiratory Muscle Training Affect Static Balance in Soccer Players? A Pilot Randomized Controlled Clinical Trial. Healthcare (Basel). 2023 Jan 14;11(2):262. doi: 10.3390/healthcare11020262.

    PubMed 36673630

Questions about this trial

What is this clinical trial studying?

A study testing diaphragmatic exercises and Respiratory muscle training in people with Sarcopenia, run by Felipe León Morillas at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Silvana L de Oliveira Sousa, Dr. (+34868884201 ext. +34, soliveira@um.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

RESPIRATORY MUSCLE FUNCTION (time frame: 24 Months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06548984, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.

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