- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03524859
Evaluation of Sit-to-stand Test in Patients With Cystic Fibrosis and Matched Controls. (STS-CF)
Comparative Analysis of Outcome Measures From Sit-to-stand Test Between Cystic Fibrosis and Healthy Subjects.
Introduction: In recent years, since the discovery of the cystic fibrosis (CF) transmembrane conductance regulator gene in human skeletal muscle, there appears to be growing interest in the measurement of muscle function in CF. One of the most used test in other chronic pulmonary diseases is the Sit-to-Stand test (STS) which consists of simply getting up from a chair. Although the main result of the STS test is the time developed during the task, the velocity and power generated during the task are considered very important variables to detect the functional decline. However, from our knowledge, no study has previously analyzed the differences in time, velocity and muscle power developed during the STS test in patients with CF and their respective healthy controls.
Objectives: To compare the values gained from handgrip strength, walking speed and STS test (time, velocity, and muscle power) in a group of patients with CF and their respective healthy controls, and to analyze if these differences (if any) are associated with lung function in patients with CF.
Methods: Cross-sectional study with a sample of 60 participants (30 patients diagnosed with CF and 30 healthy subjects) between 18-65 years old. The STS test will be measured through slow-motion video recording with a smartphone device (240 images per second) which will report the time, velocity and power generated during the test. Walking speed and handgrip strength will be also measured. Additionally, the relationship between the variables obtained during the test and the lung function of patients with CF will be analized.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
-
Murcia, Spagna, 30120
- Cystic Fibrosis Association
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Patients with cystic fibrosis clinically stable; without experience on endurance or resistance training; no receiving long-term oxygen therapy.
- Healthy matched controls; without experience on endurance or resistance training.
Exclusion Criteria:
- Using psychotropic medications; concomitant neurological, cardiovascular, metabolic, rheumatic or vestibular diseases; physical disabilities that impaired locomotion or chair rise; orthopedic problems; or a history of musculoskeletal system operations.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
---|
Cystic fibrosis
Cystic fibrosis participants without experience on endurance or resistance training will be analyzed through a test battery and lung function test.
|
Healthy Subjects
Healthy matched control group without experience on endurance or resistance training will be analyzed through a test battery.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Sit-to-stand time
Lasso di tempo: Cross-sectional baseline (non intervention)
|
The time to complete the sit-to-stand test will be measured using a smartphone (Sit-to-stand App version 1.1) installed on an iPhone 6 running iOS 11 (Apple Inc., USA). To execute the test, subjects will sit on a rigid chair with their arms crossed over their chest with the hip, knee and ankle joints at approximately 90 degrees. The subjects will be instructed to stand-up as fast as possible. Participants will complete three STS repetitions to complete the test while standing without footwear. |
Cross-sectional baseline (non intervention)
|
Sit-to-stand velocity
Lasso di tempo: Cross-sectional baseline (non intervention)
|
The vertical velocity generated by the participants during the sit-to-stand test will be measured using a smartphone (Sit-to-stand App version 1.1) installed on an iPhone 6 running iOS 11 (Apple Inc., USA). To execute the test, subjects will sit on a rigid chair with their arms crossed over their chest with the hip, knee and ankle joints at approximately 90 degrees. The subjects will be instructed to stand-up as fast as possible. Participants will complete three STS repetitions to complete the test while standing without footwear. |
Cross-sectional baseline (non intervention)
|
Sit-to-stand power
Lasso di tempo: Cross-sectional baseline (non intervention)
|
The leg power generated by the participants during the sit-to-stand test will be measured using a smartphone (Sit-to-stand App version 1.1) installed on an iPhone 6 running iOS 11 (Apple Inc., USA). To execute the test, subjects will sit on a rigid chair with their arms crossed over their chest with the hip, knee and ankle joints at approximately 90 degrees. The subjects will be instructed to stand-up as fast as possible. Participants will complete three STS repetitions to complete the test while standing without footwear. |
Cross-sectional baseline (non intervention)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Handgrip strength
Lasso di tempo: Cross-sectional baseline (non intervention)
|
Handgrip testing will be performed in standing position with the arm at the side and the forearm and wrist placed into neutral.
Using a digital hand dynamometer, subjects will squeez the device maximally.
The test will be repeated two times on both the right and left hand with 30-s of rest between trials of the same hand.
The greater of the two trials from the right and left side will be used and added together to give overall handgrip strength.
|
Cross-sectional baseline (non intervention)
|
Walking speed
Lasso di tempo: Cross-sectional baseline (non intervention)
|
Self-selected walking speed will be determined by having participants walk at a pace they consider 'normal walking speed' over a distance of 8 m on a non-carpeted floor.
To account for the time it will take participants to accelerate and decelerate, markers will be provided 2 m before and after the measured distance.
Therefore, the total timed distance will be 4 m.
The timed walking test will be completed twice to promote familiarity and improve accuracy.
|
Cross-sectional baseline (non intervention)
|
Lung function
Lasso di tempo: Cross-sectional baseline (non intervention)
|
Lung function will be measured with a calibrated spirometer by a experimented nurse.
|
Cross-sectional baseline (non intervention)
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Juan Diego Ruiz-Cárdenas, PT, Universidad Católica San Antonio de Murcia
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- UCMurcia
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Fibrosi cistica
-
National Institute of Allergy and Infectious Diseases...Completato