NCT07028034

Brief Summary

Our study aimed to investigate whether the 6 minute step test could be used as an alternative to the 6 minute walk test for assessing functional capacity in individuals with chronic low back pain.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 19, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

June 25, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

August 8, 2025

Status Verified

May 1, 2025

Enrollment Period

3 months

First QC Date

May 29, 2025

Last Update Submit

August 7, 2025

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (2)

  • Functional capacity

    Functional capacity will be assessed with a 6 minute walk test and 6 minute step test, and total distance and total number of step will be recorded. Quadriceps muscle oxygenation will be assessed with a monitor during the tests.

    1st and 2nd day

  • Muscle function

    will be evaluated with a 5 times sit to stand test and the total time recorded.

    1st day

Secondary Outcomes (2)

  • Muscle strength

    1st day

  • Disability level

    1st day

Study Arms (1)

Indıviduals with chronic low back pain

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals with chronic low back pain will be included in the study.

You may qualify if:

  • Diagnosed with chronic low back pain
  • Chronic low back pain for at least the last 3 months
  • Being aged 18-65
  • Voluntary participation in the study

You may not qualify if:

  • Having orthopedic or neurological impairments
  • History of surgery due to chronic low back pain in the last 6 months
  • Being pregnant
  • Participating in regular physical activity in the past 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kirsehir Ahi Evran University

Kırşehir, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Merve Firat

CONTACT

+90 850 441 02 44mervefirat@ahievran.edu.tr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 29, 2025

First Posted

June 19, 2025

Study Start

June 25, 2025

Primary Completion

October 1, 2025

Study Completion

March 1, 2026

Last Updated

August 8, 2025

Record last verified: 2025-05

Locations

TU(1)