Use of 1 Minute Sit to Stand Test for Physical Capacity and Effort Related Desaturation in Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05151211
• Other study ID #: Gulnergiz
• Status: Not yet recruiting
• Start date: May 30, 2024
• Est. completion date: March 1, 2025

Study information

• Verified date: December 2023
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: Asena Yekdaneh, Pt., MSc.
• Phone: 000000000000
• Email: asenayekdaneh[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 35
• Est. completion date: March 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed with ALS

• 18 years and over

• Ambulatory

• Volunteer to participate in the study

Exclusion Criteria:

• Having a comorbidity that may affect the results of the study (orthopedic, cardiopulmonary, orthopedic, psychiatric, etc.)

• Not willing to participate in the study

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Locations

Country	Name	City	State
Turkey	Istanbul University-Cerrahpasa	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Time Frame: Baseline
Primary	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.	Time Frame: Baseline
Primary	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.	Time Frame: Baseline
Primary	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.	Time Frame: Baseline
Primary	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.	Time Frame: Baseline
Primary	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.	Time Frame: Baseline
Primary	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.	Time Frame: Baseline
Primary	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.	Time Frame: Baseline