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

NCT03524859 | Completed

• 1 other identifier: UCMurcia
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis; Sit-to-stand; Lung Function; Handgrip; Walking Speed; Power; Velocity; Gait Speed; Chair rise

Outcome Measures

Primary Outcomes (3)

• Sit-to-stand time

  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

  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

  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)

Secondary Outcomes (3)

• Handgrip strength

  Cross-sectional baseline (non intervention)

• Walking speed

  Cross-sectional baseline (non intervention)

• Lung function

  Cross-sectional baseline (non intervention)

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Católica San Antonio de Murcia: lead

Study Sites (1)

Cystic Fibrosis Association

Murcia, 30120, Spain

Location

Related Publications (1)

• 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.

  PMID: 29102856 BACKGROUND

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Juan Diego Ruiz-Cárdenas, PT

  Universidad Católica San Antonio de Murcia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 2, 2018
• First Posted: May 15, 2018
• Study Start: May 3, 2018
• Primary Completion: March 26, 2019
• Study Completion: April 25, 2019
• Last Updated: April 26, 2019

Record last verified: 2019-04

Locations

ES (1)