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

NCT ID: NCT03524859

Last Updated: 2019-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

79 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-03

Study Completion Date

2019-04-25

Brief Summary

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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.

Detailed Description

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Conditions

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Cystic Fibrosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Cystic fibrosis

Cystic fibrosis participants without experience on endurance or resistance training will be analyzed through a test battery and lung function test.

No interventions assigned to this group

Healthy Subjects

Healthy matched control group without experience on endurance or resistance training will be analyzed through a test battery.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad Católica San Antonio de Murcia

OTHER

Sponsor Role lead

Responsible Party

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Juan Diego Ruiz-Cárdenas

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Juan Diego Ruiz-Cárdenas, PT

Role: PRINCIPAL_INVESTIGATOR

Universidad Católica San Antonio de Murcia

Locations

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Cystic Fibrosis Association

Murcia, , Spain

Site Status

Countries

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Spain

References

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Ruiz-Cardenas JD, Rodriguez-Juan JJ, Smart RR, Jakobi JM, Jones GR. Validity and reliability of an iPhone App to assess time, velocity and leg power during a sit-to-stand functional performance test. Gait Posture. 2018 Jan;59:261-266. doi: 10.1016/j.gaitpost.2017.10.029. Epub 2017 Oct 31.

Reference Type BACKGROUND
PMID: 29102856 (View on PubMed)

Other Identifiers

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UCMurcia

Identifier Type: -

Identifier Source: org_study_id

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