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NCT Number: NCT03524859

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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cystic Fibrosis Association

Murcia, 30120, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Universidad Católica San Antonio de Murcia

Other

Registry information

Official study title

Comparative Analysis of Outcome Measures From Sit-to-stand Test Between Cystic Fibrosis and Healthy Subjects.

Acronym: STS-CF

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 15, 2018
Registry last updated
Apr 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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