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

NCT ID: NCT05151211

Last Updated: 2023-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-30

Study Completion Date

2025-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Amyotrophic Lateral Sclerosis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Amyotrophic Lateral Sclerosis Physical capacity Desaturation Dyspne

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ayse Asena Yekdaneh

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gökşen KURAN ASLAN, Asst. Prof.

Role: STUDY_DIRECTOR

Istanbul University - Cerrahpasa

İrem Kurt, Pt., MSc.

Role: PRINCIPAL_INVESTIGATOR

Istanbul University - Cerrahpasa

Tuğba Akgüller, Pt., MSc.

Role: PRINCIPAL_INVESTIGATOR

Istanbul University - Cerrahpasa

Feray Güngör, Pt., MSc.

Role: PRINCIPAL_INVESTIGATOR

Istanbul University - Cerrahpasa

Nazlı Güngör, Pt., MSc.

Role: PRINCIPAL_INVESTIGATOR

Istanbul University - Cerrahpasa

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Istanbul University-Cerrahpasa

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Asena Yekdaneh, Pt., MSc.

Role: CONTACT

Phone: 000000000000

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Gökşen Kuran Aslan, Asst. Prof.

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Gulnergiz

Identifier Type: -

Identifier Source: org_study_id