SarcopeniaNCT06130800
Respiratory Sarcopenia in Institutionalized Older Adults in the Region of Murcia
An observational study of Sarcopenia and Respiratory Function Impaired, run by Felipe León Morillas at 1 site in Spain.
Trial summary
Objectives: The objectives of this study are to describe the prevalence of respiratory sarcopenia in institutionalized older adults. Methodology: A sample of approximately 120 older adults from 5 residences located in Murcia capital will participate in the study. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Respiratory Function Impaired
- Type of treatment
- Pill or oral medicine
- How many people
- 127 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2023to 31 Jul 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Institutionalized elderly diagnosed with respiratory sarcopenia
Who may be able to join
- To have functional ambulation and/or wheelchair.
- preserved cognitive status.
- have sufficient ability to Oral occlusion for carrying out respiratory tests.
Who cannot join
- presence of respiratory diseases or in treatment of respiratory diseases.
- serious orthopedic diseases that interfere with measurements and those with a diagnosis of dementia.
- those who present any contraindication for carrying out the procedure will be excluded.
- of the respiratory pressure measurement tests, as established in the SEPAR guidelines.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Respiratory Sarcopenia in Institutionalized Older Adults in the Region of Murcia: Prevalence and Associated Factors
Objectives: The objectives of this study are to describe the prevalence of respiratory sarcopenia in institutionalized older adults. Methodology: A sample of approximately 120 older adults from 5 residences located in Murcia capital will participate in the study. A prospective observational study will be carried out, with one year of follow-up, with patients who have been diagnosed with respiratory sarcopenia. Sociodemographic and clinical variables, physical function (palm grip, 5STS, 4MGS), respiratory force variables (MIP and PEF) and diaphragmatic ultrasound (thickness, shortening fraction and diaphragmatic excursion) will be measured. Descriptive statistics, univariate and multivariate logistic regression models, Cox proportional hazards model and KaplanMeier curves will be used to analyze the data from the longitudinal study.
- Conditions
- Sarcopenia, Respiratory Function Impaired
- Keywords
- sarcopenia, respiratory force, institutionalized elderly
- Medical subject headings
- Sarcopenia, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Wheelchair | The inclusion criteria to participate in the study are being in a wheelchair, preserved cognitive status and having sufficient ability to Oral occlusion for carrying out respiratory tests. The exclusion criteria are following: presence of respiratory diseases or in treatment of respiratory diseases, serious orthopedic diseases that interfere with measurements and those with a diagnosis of dementia. In addition, those who present any contraindication for carrying out the procedure will be excluded. of the respiratory pressure measurement tests, as established in the SEPAR guidelines. The objectives of the study and the methodology to be used will be explained to all participants. An information sheet will be provided and the informed consent sheet will be given to them. | |
| wanderers | The inclusion criteria to participate in the study are to have functional ambulation, preserved cognitive status and have sufficient ability to Oral occlusion for carrying out respiratory tests. The exclusion criteria are following: presence of respiratory diseases or in treatment of respiratory diseases, serious orthopedic diseases that interfere with measurements and those with a diagnosis of dementia. In addition, those who present any contraindication for carrying out the procedure will be excluded. of the respiratory pressure measurement tests, as established in the SEPAR guidelines. The objectives of the study and the methodology to be used will be explained to all participants. An information sheet will be provided and the informed consent sheet will be given to them. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sociodemographic
Sociodemographic dates
Measured: 8 MONTHS
Clinical variables
Clinical variables will be extracted from history clinic
Measured: 8 MONTHS
Palm grip strength
Palm grip strength will be measured with the digital hand dynamometer (Jamar©). The Participants will remain seated with the shoulder in 0° adduction; elbow flexed 90° and forearm in neutral position. Three attempts will be made and the best value will be chosen
Measured: 8 MONTHS
5 SIT TO STAND
The 5STS test measures the time (in seconds) it takes a subject to stop 5 times from a sitting position, as quickly as possible.
Measured: 8 MONTHS
4 METRES
The gait speed test (4MGS) measures the time it takes to cross a line of 4m at normal speed.
Measured: 8 MONTS
Body composition
- The analysis of body composition will be carried out with the TANITA MC 780-P MA monitor, which provides information on visceral and body fat, skeletal muscle level, BMI and basal metabolism.
Measured: 8 MONTHS
Respiratoy muscle force
To measure respiratory muscle force, the maximum respiratory pressures will be evaluated in mouth (PIM/PEM). For them we will use an inspiratory and expiratory mouth pressure monitor maximum, a module of the Datapir touch© spirometer (Sibelmed, Barcelona). The measurement will be performed by a previously trained and experienced physiotherapist, following the protocol established by the Spanish Society of Pulmonology (4-SEPAR).
Measured: 8 MONTHS
Diaphragmatic ultrasound variables
The diaphragmatic ultrasound variables examined will be mobility, thickness and fraction of shortening. For this we will use the Esaote MyLab™ Sigma ultrasound machine (Esaote SpA, Genoa, Italy), with double probe (linear and convex).
Measured: 8 MONTHS
Secondary outcomes (1)
Health results
The health outcome variables that will be recorded over a year will be: infections respiratory diseases, visit to the emergency department, hospitalization, bedridden and/or death. This Information will be extracted from the patient's clinical record.
Measured: 8 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start1 May 2023
- Primary completion31 Dec 2023
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 127 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Felipe León Morillas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Felipe León Morillas, Catholic University of Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06130800
- Sponsor's protocol ID
- SarcoRespi
- Status last verified
- Jan 2024
- First submitted
- 30 Oct 2023
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Sarcopenia in Institutionalized Older Adults in the Region of Murcia: Prevalence and Associated Factors
- ClinicalTrials.gov ID
- NCT06130800
- Acronym / sponsor ID
- SarcoRespi
- Conditions
- Sarcopenia, Respiratory Function Impaired
- Keywords
- sarcopenia, respiratory force, institutionalized elderly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Felipe León MorillasUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 14 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives: The objectives of this study are to describe the prevalence of respiratory sarcopenia in institutionalized older adults. Methodology: A sample of approximately 120 older adults from 5 residences located in Murcia capital will participate in the study. A prospective observational study will be carried out, with one year of follow-up, with patients who have been diagnosed with respiratory sarcopenia. Sociodemographic and clinical variables, physical function (palm grip, 5STS, 4MGS), respiratory force variables (MIP and PEF) and diaphragmatic ultrasound (thickness, shortening fraction and diaphragmatic excursion) will be measured. Descriptive statistics, univariate and multivariate logistic regression models, Cox proportional hazards model and KaplanMeier curves will be used to analyze the data from the longitudinal study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wheelchair | – | –The inclusion criteria to participate in the study are being in a wheelchair, preserved cognitive status and having sufficient ability to Oral occlusion for carrying out respiratory tests. The exclusion criteria are following: presence of respiratory diseases or in treatment of respiratory diseases, serious orthopedic diseases that interfere with measurements and those with a diagnosis of dementia. In addition, those who present any contraindication for carrying out the procedure will be excluded. of the respiratory pressure measurement tests, as established in the SEPAR guidelines. The objectives of the study and the methodology to be used will be explained to all participants. An information sheet will be provided and the informed consent sheet will be given to them. |
| wanderers | – | –The inclusion criteria to participate in the study are to have functional ambulation, preserved cognitive status and have sufficient ability to Oral occlusion for carrying out respiratory tests. The exclusion criteria are following: presence of respiratory diseases or in treatment of respiratory diseases, serious orthopedic diseases that interfere with measurements and those with a diagnosis of dementia. In addition, those who present any contraindication for carrying out the procedure will be excluded. of the respiratory pressure measurement tests, as established in the SEPAR guidelines. The objectives of the study and the methodology to be used will be explained to all participants. An information sheet will be provided and the informed consent sheet will be given to them. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Institutionalized elderly diagnosed with respiratory sarcopenia
Key inclusion criteria (3 listed)
- To have functional ambulation and/or wheelchair.
- preserved cognitive status.
- have sufficient ability to Oral occlusion for carrying out respiratory tests.
Key exclusion criteria (4 listed)
- presence of respiratory diseases or in treatment of respiratory diseases.
- serious orthopedic diseases that interfere with measurements and those with a diagnosis of dementia.
- those who present any contraindication for carrying out the procedure will be excluded.
- of the respiratory pressure measurement tests, as established in the SEPAR guidelines.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sociodemographic
Time frame: 8 MONTHS
Sociodemographic dates
Clinical variables
Time frame: 8 MONTHS
Clinical variables will be extracted from history clinic
Palm grip strength
Time frame: 8 MONTHS
Palm grip strength will be measured with the digital hand dynamometer (Jamar©). The Participants will remain seated with the shoulder in 0° adduction; elbow flexed 90° and forearm in neutral position. Three attempts will be made and the best value will be chosen
5 SIT TO STAND
Time frame: 8 MONTHS
The 5STS test measures the time (in seconds) it takes a subject to stop 5 times from a sitting position, as quickly as possible.
4 METRES
Time frame: 8 MONTS
The gait speed test (4MGS) measures the time it takes to cross a line of 4m at normal speed.
Body composition
Time frame: 8 MONTHS
- The analysis of body composition will be carried out with the TANITA MC 780-P MA monitor, which provides information on visceral and body fat, skeletal muscle level, BMI and basal metabolism.
Respiratoy muscle force
Time frame: 8 MONTHS
To measure respiratory muscle force, the maximum respiratory pressures will be evaluated in mouth (PIM/PEM). For them we will use an inspiratory and expiratory mouth pressure monitor maximum, a module of the Datapir touch© spirometer (Sibelmed, Barcelona). The measurement will be performed by a previously trained and experienced physiotherapist, following the protocol established by the Spanish Society of Pulmonology (4-SEPAR).
Diaphragmatic ultrasound variables
Time frame: 8 MONTHS
The diaphragmatic ultrasound variables examined will be mobility, thickness and fraction of shortening. For this we will use the Esaote MyLab™ Sigma ultrasound machine (Esaote SpA, Genoa, Italy), with double probe (linear and convex).
1 secondary outcome
Health results
Time frame: 8 MONTHS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia and Respiratory Function Impaired, 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: finished, as of the sponsor's last update on 20 Aug 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sociodemographic (time frame: 8 MONTHS). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2025.