Cystic FibrosisSTS-CFNCT03524859
Evaluation of Sit-to-stand Test in Patients With Cystic Fibrosis and Matched Controls.
An observational study of Cystic Fibrosis, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 79 participants
- Where
- 1 siteSpain
- Study dates
- 3 May 2018to 25 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Analysis of Outcome Measures From Sit-to-stand Test Between Cystic Fibrosis and Healthy Subjects.
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
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Cross-sectional baseline (non intervention)
Secondary outcomes (3)
Handgrip strength
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.
Measured: Cross-sectional baseline (non intervention)
Walking speed
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.
Measured: Cross-sectional baseline (non intervention)
Lung function
Lung function will be measured with a calibrated spirometer by a experimented nurse.
Measured: Cross-sectional baseline (non intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2018
- Study start3 May 2018
- Primary completion26 Mar 2019
- Study completion25 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Diego Ruiz-Cárdenas, Universidad Católica San Antonio de Murcia
- Investigators
- Juan Diego Ruiz-Cárdenas, PT, Principal investigator, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03524859
- Sponsor's protocol ID
- UCMurcia
- Acronym
- STS-CF
- Status last verified
- Apr 2019
- First submitted
- 2 May 2018
- Last updated
- 26 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29102856
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Outcome Measures From Sit-to-stand Test Between Cystic Fibrosis and Healthy Subjects.
- ClinicalTrials.gov ID
- NCT03524859
- Acronym / sponsor ID
- STS-CF / UCMurcia
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, Sit-to-stand, Lung Function, Handgrip, Walking Speed, Power, Velocity, Gait Speed
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 3 May 2018 (actual)
- Primary completion
- 26 Mar 2019 (actual)
- Study completion
- 25 Apr 2019 (actual)
- First posted
- 15 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
3 secondary outcomes
Handgrip strength
Time frame: Cross-sectional baseline (non intervention)
Walking speed
Time frame: Cross-sectional baseline (non intervention)
Lung function
Time frame: Cross-sectional baseline (non intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
- Background: PubMed 29102856Ruiz-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Diego Ruiz-Cárdenas, PT principal investigator
Universidad Católica San Antonio de Murcia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sit-to-stand time (time frame: Cross-sectional baseline (non intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03524859, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2019.