Clinical trial NCT03524859: Evaluation of Sit-to-stand Test in Patients With Cystic Fibrosis and Matched Controls.
Official title: Comparative Analysis of Outcome Measures From Sit-to-stand Test Between Cystic Fibrosis and Healthy Subjects.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Keywords: Cystic Fibrosis
Sit-to-stand
Lung Function
Handgrip
Walking Speed
Power
Velocity
Gait Speed
Chair rise
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2018-05-15
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility 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.

Primary outcomes:
measure: Sit-to-stand time
timeFrame: Cross-sectional baseline (non intervention)
measure: Sit-to-stand velocity
timeFrame: Cross-sectional baseline (non intervention)
measure: Sit-to-stand power
timeFrame: Cross-sectional baseline (non intervention)
Secondary outcomes:
measure: Handgrip strength
timeFrame: Cross-sectional baseline (non intervention)
measure: Walking speed
timeFrame: Cross-sectional baseline (non intervention)
measure: Lung function
timeFrame: Cross-sectional baseline (non intervention)
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Cystic Fibrosis Association
Study officials:
affiliation: Universidad Católica San Antonio de Murcia
name: Juan Diego Ruiz-Cárdenas, PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.