Validity and Reliability of the Two-minute Step Test in Hemophilia

NCT07425327 | Not Yet Recruiting

• 1 other identifier: 2025/157
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of our study was to evaluate the psychometric properties of the 2-minute step test in hemophilia patients, assess its intra-rater and inter-rater reliability, and evaluate its convergent validity and construct validity supported by measurements of gait, balance, and functionality.

Conditions

Hemophilia; Step; Reliability and Validity

Keywords

Hemophilia A; Hemophilia B; Two minute step test

Outcome Measures

Primary Outcomes (1)

• 2-Minute Step Test

  The 2MST is widely used to assess aerobic endurance and physical fitness. In this study, the 2MST protocol developed by Rikli and Jones will be used. Before the test, the midpoint between the anterior superior iliac spine and the top of the patella will be measured for each participant, and the target height for knee elevation will be marked on the wall with adhesive tape for standardization. Upon hearing the verbal cue "Go," participants will begin walking (not running) in place and will lift each knee to reach the target height. The test will be timed with a stopwatch, and the number of steps will be recorded directly by observation by a physical therapist.

  through of the study, average 4 months

Secondary Outcomes (3)

• 2-Minute Walk Test (2MWT):

  through of the study, average 4 months

• Timed Up and Go Test (TUG):

  through of the study, average 4 months

• One-Legged Standing Test:

  through of the study, average 4 months

Study Arms (1)

Hemophilia Group

The sample population consists of hemophilia patients aged 6-18 years who are receiving outpatient treatment, who voluntarily participate in the study and who meet the inclusion criteria. An appropriate sampling method will be used in the selection of the sample.

Eligibility Criteria

• Age: 6 Years - 18 Years
• Gender Eligibility Details: Hemophilia X is a genetically inherited disease, so women are carriers. Symptoms are observed in males.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The sample population consists of hemophilia patients aged 6-18 who are receiving outpatient treatment, who voluntarily participate in the study and meet the inclusion criteria. An appropriate sampling method will be used in the sample selection.

You may qualify if:

• Diagnosed with Hemophilia (A-B) by a physician,
• Aged 6-18 years,
• Receiving regular prophylactic treatment,
• Inhibitor positive or negative,
• No history of lower extremity joint bleeding within the last month,
• Individuals who are willing to participate in the study,

You may not qualify if:

• Patients who have undergone surgery on the lower extremities for any reason within the last 6 months,
• Patients with neurological sequelae following a history of intracranial hemorrhage,
• Patients experiencing cognitive impairment to the extent that they cannot understand the tests,
• Patients who indicate they will be unable to participate in follow-up measurements.

Sponsors & Collaborators

• Hasan Kalyoncu University: lead

Study Sites (1)

Hasan Kalyoncu University

Gaziantep, Şahinbey, (505) 090-5846, Turkey (Türkiye)

Location

Related Publications (5)

• Nogueira MA, Almeida TDN, Andrade GS, Ribeiro AS, Rego AS, Dias RDS, Ferreira PR, Penha LRLN, Pires FO, Dibai-Filho AV, Bassi-Dibai D. Reliability and Accuracy of 2-Minute Step Test in Active and Sedentary Lean Adults. J Manipulative Physiol Ther. 2021 Feb;44(2):120-127. doi: 10.1016/j.jmpt.2020.07.013. Epub 2021 Jan 9.

  PMID: 33431278 RESULT

• Cederberg KLJ, Sikes EM, Bartolucci AA, Motl RW. Walking endurance in multiple sclerosis: Meta-analysis of six-minute walk test performance. Gait Posture. 2019 Sep;73:147-153. doi: 10.1016/j.gaitpost.2019.07.125. Epub 2019 Jul 10.

  PMID: 31326830 RESULT

• Shumway-Cook A, Brauer S, Woollacott M. Predicting the probability for falls in community-dwelling older adults using the Timed Up & Go Test. Phys Ther. 2000 Sep;80(9):896-903.

  PMID: 10960937 RESULT

• Eriksen L, Curtis T, Gronbaek M, Helge JW, Tolstrup JS. The association between physical activity, cardiorespiratory fitness and self-rated health. Prev Med. 2013 Dec;57(6):900-2. doi: 10.1016/j.ypmed.2013.09.024. Epub 2013 Oct 5.

  PMID: 24099878 RESULT

• Srivastava A, Santagostino E, Dougall A, Kitchen S, Sutherland M, Pipe SW, Carcao M, Mahlangu J, Ragni MV, Windyga J, Llinas A, Goddard NJ, Mohan R, Poonnoose PM, Feldman BM, Lewis SZ, van den Berg HM, Pierce GF; WFH Guidelines for the Management of Hemophilia panelists and co-authors. WFH Guidelines for the Management of Hemophilia, 3rd edition. Haemophilia. 2020 Aug;26 Suppl 6:1-158. doi: 10.1111/hae.14046. Epub 2020 Aug 3. No abstract available.

  PMID: 32744769 RESULT

MeSH Terms

Conditions

Hemophilia A; Hemophilia B

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, X-Linked

Study Officials

• Tuğba GÖNEN, Asisst. Prof. Dr.

  Hasan Kalyoncu University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tuğba GÖNEN, Asisst. Prof. Dr.

CONTACT

505 090 58 46; tugba.badat@hku.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asisst. Prof. Dr.

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: February 20, 2026
• Study Start: February 25, 2026
• Primary Completion: April 25, 2026
• Study Completion (Estimated): June 25, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)