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

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ClinicalTrials.gov Identifier: NCT03524859
Recruitment Status : Completed
First Posted : May 15, 2018
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Juan Diego Ruiz-Cárdenas, Universidad Católica San Antonio de Murcia

Brief Summary:

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.


Condition or disease
Cystic Fibrosis

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Study Type : Observational
Actual Enrollment : 79 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Comparative Analysis of Outcome Measures From Sit-to-stand Test Between Cystic Fibrosis and Healthy Subjects.
Actual Study Start Date : May 3, 2018
Actual Primary Completion Date : March 26, 2019
Actual Study Completion Date : April 25, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Group/Cohort
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.



Primary Outcome Measures :
  1. Sit-to-stand time [ Time Frame: 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.


  2. Sit-to-stand velocity [ Time Frame: 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.


  3. Sit-to-stand power [ Time Frame: 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.



Secondary Outcome Measures :
  1. Handgrip strength [ Time Frame: 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.

  2. Walking speed [ Time Frame: 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.

  3. Lung function [ Time Frame: Cross-sectional baseline (non intervention) ]
    Lung function will be measured with a calibrated spirometer by a experimented nurse.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03524859


Locations
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Spain
Cystic Fibrosis Association
Murcia, Spain, 30120
Sponsors and Collaborators
Universidad Católica San Antonio de Murcia
Investigators
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Principal Investigator: Juan Diego Ruiz-Cárdenas, PT Universidad Católica San Antonio de Murcia

Publications:
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Responsible Party: Juan Diego Ruiz-Cárdenas, Principal Investigator, Universidad Católica San Antonio de Murcia
ClinicalTrials.gov Identifier: NCT03524859     History of Changes
Other Study ID Numbers: UCMurcia
First Posted: May 15, 2018    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Juan Diego Ruiz-Cárdenas, Universidad Católica San Antonio de Murcia:
Cystic Fibrosis
Sit-to-stand
Lung Function
Handgrip
Walking Speed
Power
Velocity
Gait Speed
Chair rise
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases