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Evaluation of Sit-to-stand Test in Patients With Cystic Fibrosis and Matched Controls. (STS-CF)

25. april 2019 opdateret af: Juan Diego Ruiz-Cárdenas, Universidad Católica San Antonio de Murcia

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.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

79

Kontakter og lokationer

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Studiesteder

      • Murcia, Spanien, 30120
        • Cystic Fibrosis Association

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients with cystic fibrosis will be recruited from the Cystic Fibrosis Association of Murcia, Spain. Additionally, a non-probabilistic sample from healthy subjects will be enrolled.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sit-to-stand time
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Handgrip strength
Tidsramme: 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
Tidsramme: 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
Tidsramme: Cross-sectional baseline (non intervention)
Lung function will be measured with a calibrated spirometer by a experimented nurse.
Cross-sectional baseline (non intervention)

Samarbejdspartnere og efterforskere

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Efterforskere

  • Ledende efterforsker: Juan Diego Ruiz-Cárdenas, PT, Universidad Católica San Antonio de Murcia

Publikationer og nyttige links

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Datoer for undersøgelser

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Studer store datoer

Studiestart (Faktiske)

3. maj 2018

Primær færdiggørelse (Faktiske)

26. marts 2019

Studieafslutning (Faktiske)

25. april 2019

Datoer for studieregistrering

Først indsendt

2. maj 2018

Først indsendt, der opfyldte QC-kriterier

13. maj 2018

Først opslået (Faktiske)

15. maj 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. april 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. april 2019

Sidst verificeret

1. april 2019

Mere information

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