Amyotrophic Lateral SclerosisNCT05151211
Use of 1 Minute Sit to Stand Test for Physical Capacity and Effort Related Desaturation in Amyotrophic Lateral Sclerosis
An observational study of Amyotrophic Lateral Sclerosis, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the usability of the 1 Minute Sit to Stand Test (1 MSTS) in evaluating physical capacity and effort-related desaturation in individuals with Amyotrophic Lateral Sclerosis (ALS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 May 2024to 1 Mar 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with ALS who come to Bakırköy Psychiatric Hospital, Neurology Clinic and meet the inclusion criteria
Who may be able to join
- Diagnosed with ALS
- 18 years and over
- Ambulatory
- Volunteer to participate in the study
Who cannot join
- Having a comorbidity that may affect the results of the study (orthopedic, cardiopulmonary, orthopedic, psychiatric, etc.)
- Not willing to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa
Istanbul
Gökşen Kuran Aslan, Asst. Prof.
About this study
Official title: Investigation of the Use of 1 Minute Sit to Stand Test to Evaluate Physical Capacity and Effort-Related Desaturation in Individuals With Amyotrophic Lateral Sclerosis
The aim of this study is to investigate the usability of the 1 Minute Sit to Stand Test (1 MSTS) in evaluating physical capacity and effort-related desaturation in individuals with Amyotrophic Lateral Sclerosis (ALS). In this context, patients diagnosed with ALS who meet the inclusion criteria will be included in the study. For the physical capacity assessment of patients with ALS at different ambulatory levels included in this study, a 6 minutes walking test (6 MWT) and a 1 MSTS will be applied. Before and at the end of the test, the severity of dyspnea and leg fatigue of the patients will be determined by the Modified Borg Scale; effort-induced desaturation and heart rate by fingertip pulse oximetry; peripheral muscle strength (for the quadriceps femoris muscle) will be evaluated with a hand held dynamometer. When the studies are examined, it has been determined that the 6 MWT is relatively difficult to tolerate in individuals with ALS, it may be difficult to provide the necessary space and equipment for the test, and a shorter, easy-to-apply, and practical evaluation method that can be used instead of this test in the clinic is needed. As a result of this study, the usability of the 1 MSTS in individuals with ambulatory ALS in evaluating physical capacity and desaturation due to effort will be revealed.
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Amyotrophic Lateral Sclerosis, Physical capacity, Desaturation, Dyspne
- Medical subject headings
- Amyotrophic Lateral Sclerosis
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 |
|---|---|---|
| Validity and Reliability Group | In order to evaluate the usability of the 1 MSTS, the validity and reliability of the test will be examined. In order to determine its validity in assessing physical capacity, the correlation of 1 minute sit up and 6 MWT and quadriceps muscle strength; In order to determine its validity in the evaluation of effort-induced desaturation, the correlation between the change in oxygen saturation and heart rate parameters before and after the 6 MWT and the change before and after the 1 MSTS test will be examined. In order to determine the reliability of the 1 MSTS, a re-test will be performed and 1 MSTS will be applied again after 1 week and the intraclass correlation coefficient will be checked. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ALS Functional Rating Scale (ALSFRS)
ALSFRS, which is used to evaluate the functional status of individuals with ALS, is a scale consisting of 12 parameters: speech, salivation, swallowing, handwriting, feeding, dressing and self-care, turning and covering in bed, walking, climbing stairs, dyspnea, orthopnea and respiratory failure. And evaluated out of a total of 48 points. Each question is scored between 0 and 4 points. While the functionally normal patient gets four points, the scores decrease from four depending on the functional deterioration and zero point is given to the worst functional condition. In this study, the functional levels of the participants will be evaluated with this scale.
Measured: Time Frame: Baseline
1 Minute Sit to Stand Test (1MSTS)
1MSTS will be administered using an armless chair (height = 43 cm). Participants will be asked to sit and stand as quickly and safely as possible for one minute from the time the time starts. The number of times to get out of the chair completed in one minute will be counted and recorded as the test result. In this study, the functionality of the participants will be evaluated with this test.
Measured: Time Frame: Baseline
6 Minutes Walking Test (6MWT)
The 6MWT is a submaximal exercise test used to evaluate aerobic capacity and endurance. The distance traveled during the test is used as an outcome measure to determine physical capacity. In this context, an area of 30 meters long will be determined with cones, and the participants will be asked to walk the maximum distance they can walk between two cones for six minutes. At the end of each minute, a standardized notification will be given, reminding the remaining time and instructing to continue. After six minutes, the total distance walked will be recorded in meters. The greater the distance walked, the greater the test result. In this study, the physical capacity of the participants will be evaluated with this test.
Measured: Time Frame: Baseline
Modified Borg Scale (MBS)
It will be used to evaluate dyspnea and lower extremity muscle fatigue of individuals with ALS before and after the 6 minute walking test and 1 minute sit to stand test. MBS is a scale that is frequently used to evaluate the severity of dyspnea on exertion and severity of dyspnea at rest. It consists of ten items describing the severity of dyspnea according to their degrees.It is similarly used to determine lower extremity fatigue; zero indicates no fatigue in the lower extremities, while the person experiencing maximal fatigue gets 10 points.
Measured: Time Frame: Baseline
Heart Rate Measurement
Before and after the 6 minute walking test and 1 minute sit to stand test, heart rate of the participants will be evaluated with by pulse oximetry. A pulse oximeter is a small, lightweight device used to monitor the amount of oxygen carried in the body and also heart rate. Heart rate, is the number of times the heart beats per minute. A normal resting heart rate should be between 60 to 100 beats per minute. Lower than 60 and higher than 100 can indicate heart rate anomaly.
Measured: Time Frame: Baseline
Quadriceps Muscle Strength
Quadriceps muscle strength will be evaluated bilaterally using a hand held dynamometer. Measurements were to be repeated 2 times in the manual muscle test position and with adequate rest intervals, with the highest value recorded in pounds (lbs). In this study, the quadriceps muscle strength of the participants will be evaluated with this test.
Measured: Time Frame: Baseline
Dyspnea ALS 15 (DALS-15)
The DALS-15 is a one-dimensional scale developed to assess shortness of breath in ALS patients. It can be applied very quickly and easily. The questionnaire consists of 15 questions that the patient can easily answer on their own. The patient expresses his/her condition in the last 2 weeks using a 3-point Likert scale (0=never, 1=occasionally, and 2=often). The total score ranges from 0 (no dyspnea) to a maximum of 30 (severe dyspnea). The higher the score, the greater the severity of dyspnea. In this study, the shortness of breath status of the participants will be evaluated with this scale.
Measured: Time Frame: Baseline
Oxygen Saturation Measurement (SpO2 Measurement)
Before and after the 6 minute walking test and 1 minute sit to stand test, the SpO2 of the participants will be evaluated with by pulse oximetry. A pulse oximeter is a small, light weight device used to monitor the amount of oxygen carried in the body and also heart rate. This non invasive tool will be attached painlessly to paticipants fingertip, sending two wave lengths of light through the finger to measure paticipants heart rate and how much oxygen is in the system. An oxygen saturation level of 95 percent is considered typical for most healthy people. Lower than this percent can indicate low level of oxygen in the blood.
Measured: Time Frame: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start30 May 2024 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Asena Yekdaneh, Istanbul University - Cerrahpasa
- Investigators
- Gökşen KURAN ASLAN, Asst. Prof., Study director, Istanbul University - Cerrahpasaİrem Kurt, Pt., MSc., Principal investigator, Istanbul University - CerrahpasaTuğba Akgüller, Pt., MSc., Principal investigator, Istanbul University - CerrahpasaFeray Güngör, Pt., MSc., Principal investigator, Istanbul University - CerrahpasaNazlı Güngör, Pt., MSc., Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05151211
- Sponsor's protocol ID
- Gulnergiz
- Status last verified
- Dec 2023
- First submitted
- 13 Nov 2021
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Use of 1 Minute Sit to Stand Test to Evaluate Physical Capacity and Effort-Related Desaturation in Individuals With Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT05151211
- Acronym / sponsor ID
- Gulnergiz
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Amyotrophic Lateral Sclerosis, Physical capacity, Desaturation, Dyspne
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 30 May 2024 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 9 Dec 2021 (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.
The aim of this study is to investigate the usability of the 1 Minute Sit to Stand Test (1 MSTS) in evaluating physical capacity and effort-related desaturation in individuals with Amyotrophic Lateral Sclerosis (ALS). In this context, patients diagnosed with ALS who meet the inclusion criteria will be included in the study. For the physical capacity assessment of patients with ALS at different ambulatory levels included in this study, a 6 minutes walking test (6 MWT) and a 1 MSTS will be applied. Before and at the end of the test, the severity of dyspnea and leg fatigue of the patients will be determined by the Modified Borg Scale; effort-induced desaturation and heart rate by fingertip pulse oximetry; peripheral muscle strength (for the quadriceps femoris muscle) will be evaluated with a hand held dynamometer. When the studies are examined, it has been determined that the 6 MWT is relatively difficult to tolerate in individuals with ALS, it may be difficult to provide the necessary space and equipment for the test, and a shorter, easy-to-apply, and practical evaluation method that can be used instead of this test in the clinic is needed. As a result of this study, the usability of the 1 MSTS in individuals with ambulatory ALS in evaluating physical capacity and desaturation due to effort will be revealed.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Validity and Reliability Group | – | –In order to evaluate the usability of the 1 MSTS, the validity and reliability of the test will be examined. In order to determine its validity in assessing physical capacity, the correlation of 1 minute sit up and 6 MWT and quadriceps muscle strength; In order to determine its validity in the evaluation of effort-induced desaturation, the correlation between the change in oxygen saturation and heart rate parameters before and after the 6 MWT and the change before and after the 1 MSTS test will be examined. In order to determine the reliability of the 1 MSTS, a re-test will be performed and 1 MSTS will be applied again after 1 week and the intraclass correlation coefficient will be checked. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with ALS who come to Bakırköy Psychiatric Hospital, Neurology Clinic and meet the inclusion criteria
Key inclusion criteria (4 listed)
- Diagnosed with ALS
- 18 years and over
- Ambulatory
- Volunteer to participate in the study
Key exclusion criteria (2 listed)
- Having a comorbidity that may affect the results of the study (orthopedic, cardiopulmonary, orthopedic, psychiatric, etc.)
- Not willing to participate in the study
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
ALS Functional Rating Scale (ALSFRS)
Time frame: Time Frame: Baseline
ALSFRS, which is used to evaluate the functional status of individuals with ALS, is a scale consisting of 12 parameters: speech, salivation, swallowing, handwriting, feeding, dressing and self-care, turning and covering in bed, walking, climbing stairs, dyspnea, orthopnea and respiratory failure. And evaluated out of a total of 48 points. Each question is scored between 0 and 4 points. While the functionally normal patient gets four points, the scores decrease from four depending on the functional deterioration and zero point is given to the worst functional condition. In this study, the functional levels of the participants will be evaluated with this scale.
1 Minute Sit to Stand Test (1MSTS)
Time frame: Time Frame: Baseline
1MSTS will be administered using an armless chair (height = 43 cm). Participants will be asked to sit and stand as quickly and safely as possible for one minute from the time the time starts. The number of times to get out of the chair completed in one minute will be counted and recorded as the test result. In this study, the functionality of the participants will be evaluated with this test.
6 Minutes Walking Test (6MWT)
Time frame: Time Frame: Baseline
The 6MWT is a submaximal exercise test used to evaluate aerobic capacity and endurance. The distance traveled during the test is used as an outcome measure to determine physical capacity. In this context, an area of 30 meters long will be determined with cones, and the participants will be asked to walk the maximum distance they can walk between two cones for six minutes. At the end of each minute, a standardized notification will be given, reminding the remaining time and instructing to continue. After six minutes, the total distance walked will be recorded in meters. The greater the distance walked, the greater the test result. In this study, the physical capacity of the participants will be evaluated with this test.
Modified Borg Scale (MBS)
Time frame: Time Frame: Baseline
It will be used to evaluate dyspnea and lower extremity muscle fatigue of individuals with ALS before and after the 6 minute walking test and 1 minute sit to stand test. MBS is a scale that is frequently used to evaluate the severity of dyspnea on exertion and severity of dyspnea at rest. It consists of ten items describing the severity of dyspnea according to their degrees.It is similarly used to determine lower extremity fatigue; zero indicates no fatigue in the lower extremities, while the person experiencing maximal fatigue gets 10 points.
Heart Rate Measurement
Time frame: Time Frame: Baseline
Before and after the 6 minute walking test and 1 minute sit to stand test, heart rate of the participants will be evaluated with by pulse oximetry. A pulse oximeter is a small, lightweight device used to monitor the amount of oxygen carried in the body and also heart rate. Heart rate, is the number of times the heart beats per minute. A normal resting heart rate should be between 60 to 100 beats per minute. Lower than 60 and higher than 100 can indicate heart rate anomaly.
Quadriceps Muscle Strength
Time frame: Time Frame: Baseline
Quadriceps muscle strength will be evaluated bilaterally using a hand held dynamometer. Measurements were to be repeated 2 times in the manual muscle test position and with adequate rest intervals, with the highest value recorded in pounds (lbs). In this study, the quadriceps muscle strength of the participants will be evaluated with this test.
Dyspnea ALS 15 (DALS-15)
Time frame: Time Frame: Baseline
The DALS-15 is a one-dimensional scale developed to assess shortness of breath in ALS patients. It can be applied very quickly and easily. The questionnaire consists of 15 questions that the patient can easily answer on their own. The patient expresses his/her condition in the last 2 weeks using a 3-point Likert scale (0=never, 1=occasionally, and 2=often). The total score ranges from 0 (no dyspnea) to a maximum of 30 (severe dyspnea). The higher the score, the greater the severity of dyspnea. In this study, the shortness of breath status of the participants will be evaluated with this scale.
Oxygen Saturation Measurement (SpO2 Measurement)
Time frame: Time Frame: Baseline
Before and after the 6 minute walking test and 1 minute sit to stand test, the SpO2 of the participants will be evaluated with by pulse oximetry. A pulse oximeter is a small, light weight device used to monitor the amount of oxygen carried in the body and also heart rate. This non invasive tool will be attached painlessly to paticipants fingertip, sending two wave lengths of light through the finger to measure paticipants heart rate and how much oxygen is in the system. An oxygen saturation level of 95 percent is considered typical for most healthy people. Lower than this percent can indicate low level of oxygen in the blood.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Gökşen KURAN ASLAN, Asst. Prof. study director
Istanbul University - Cerrahpasa
İrem Kurt, Pt., MSc. principal investigator
Istanbul University - Cerrahpasa
Tuğba Akgüller, Pt., MSc. principal investigator
Istanbul University - Cerrahpasa
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 Amyotrophic Lateral Sclerosis, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 7 Dec 2023. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asena Yekdaneh, Pt., MSc. (000000000000, asenayekdaneh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ALS Functional Rating Scale (ALSFRS) (time frame: Time Frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Dec 2023.