- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06130800
Respiratory Sarcopenia in Institutionalized Older Adults in the Region of Murcia
Respiratory Sarcopenia in Institutionalized Older Adults in the Region of Murcia: Prevalence and Associated Factors
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Murcia, Spain
- Residence of the elderly
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- To have functional ambulation and/or wheelchair.
- preserved cognitive status.
- have sufficient ability to Oral occlusion for carrying out respiratory tests.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Sociodemographic
Time Frame: 8 MONTHS
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Sociodemographic dates
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8 MONTHS
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Clinical variables
Time Frame: 8 MONTHS
|
Clinical variables will be extracted from history clinic
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8 MONTHS
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Palm grip strength
Time Frame: 8 MONTHS
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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
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8 MONTHS
|
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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.
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8 MONTHS
|
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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.
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8 MONTS
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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.
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8 MONTHS
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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).
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8 MONTHS
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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).
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8 MONTHS
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health results
Time Frame: 8 MONTHS
|
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.
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8 MONTHS
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SarcoRespi
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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