Clinical trial NCT05151211: Use of 1 Minute Sit to Stand Test for Physical Capacity and Effort Related Desaturation in Amyotrophic Lateral Sclerosis
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Amyotrophic Lateral Sclerosis
Keywords: Amyotrophic Lateral Sclerosis
Physical capacity
Desaturation
Dyspne
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with ALS who come to Bakırköy Psychiatric Hospital, Neurology Clinic and meet the inclusion criteria

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: ALS Functional Rating Scale (ALSFRS)
timeFrame: Time Frame: Baseline
measure: 1 Minute Sit to Stand Test (1MSTS)
timeFrame: Time Frame: Baseline
measure: 6 Minutes Walking Test (6MWT)
timeFrame: Time Frame: Baseline
measure: Modified Borg Scale (MBS)
timeFrame: Time Frame: Baseline
measure: Heart Rate Measurement
timeFrame: Time Frame: Baseline
measure: Quadriceps Muscle Strength
timeFrame: Time Frame: Baseline
measure: Dyspnea ALS 15 (DALS-15)
timeFrame: Time Frame: Baseline
measure: Oxygen Saturation Measurement (SpO2 Measurement)
timeFrame: Time Frame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Gökşen KURAN ASLAN, Asst. Prof.
role: STUDY_DIRECTOR
affiliation: Istanbul University - Cerrahpasa
name: İrem Kurt, Pt., MSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University - Cerrahpasa
name: Tuğba Akgüller, Pt., MSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University - Cerrahpasa
name: Feray Güngör, Pt., MSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University - Cerrahpasa
name: Nazlı Güngör, Pt., MSc.
role: PRINCIPAL_INVESTIGATOR
References: