NCT06806514

Brief Summary

The aim of the study was to evaluate the upper extremity exercise capacity of individuals with chronic low back pain and to investigate its relationship with respiratory muscle strength, peripheral muscle strength, chest expansion, pain, disability level, fear of movement and quality of life.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2025

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

February 3, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 4, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

June 2, 2025

Status Verified

February 1, 2025

Enrollment Period

10 months

First QC Date

February 3, 2025

Last Update Submit

May 28, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • Upper extremity exercise capacity

    It will be assessed by 6 minute pegboard and ring test.

    1st day

  • Respiratory muscle strength

    Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) will be measured using a portable mouth pressure device.

    1st day

  • Peripheral muscle strength

    Knee extensor, shoulder abductor and hand grip strength will be evaluated with a dynamometer.

    1st day

  • Chest expansion

    Neutral, deep inspiration and deep expiration circumferences will be measured from the axillary, epigastric and subcostal regions using a tape measure.

    1st day

  • Disability level

    It will be assessed with Oswestry Disability Index. High scores on the scale indicate the presence and severity of symptoms.

    1st day

Secondary Outcomes (2)

  • Kinesiophobia

    1st day

  • Quality of life

    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 who are being followed up at the Department of Physical Medicine and Rehabilitation at Kirsehir Ahi Evran University will be included in the study.

You may qualify if:

  • Voluntary participation in the study
  • Being aged 18-65
  • Chronic low back pain for at least the last 3 months
  • Pain intensity according to Visual Analogue Scale (VAS) ≥3

You may not qualify if:

  • History of cancer
  • Presence of spinal infection
  • Presence of rheumatological disorders
  • Presence of spinal fracture
  • Red flag signs
  • Having a psychological disorder
  • Presence of spinal surgery
  • Having radiculopathy
  • Presence of anatomical and congenital abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kirsehir Ahi Evran University

Kırşehir, Turkey (Türkiye)

RECRUITING

Central Study Contacts

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

February 3, 2025

First Posted

February 4, 2025

Study Start

February 3, 2025

Primary Completion

December 1, 2025

Study Completion

May 1, 2026

Last Updated

June 2, 2025

Record last verified: 2025-02

Locations