NCT06943066

Brief Summary

Pilates exercises administered under the supervision of a physiotherapist on pain, endurance, and muscle strength in individuals with non-specific low back pain, and to determine which program is more beneficial and reliable.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 6, 2025

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 24, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2025

Completed
Last Updated

August 12, 2025

Status Verified

August 1, 2025

Enrollment Period

2 months

First QC Date

April 17, 2025

Last Update Submit

August 11, 2025

Conditions

Keywords

exercise

Outcome Measures

Primary Outcomes (6)

  • Visual Analog Scale

    A 10-cm line where participants mark their pain intensity, ranging from 'no pain' to 'worst pain'.

    12 weeks

  • Oswestry Disability Index

    A 10-section questionnaire evaluating the impact of back pain on daily activities. maximum point 56

    12 weeks

  • Fatigue Severity Scale

    A 9-item self-report scale where participants rate how fatigue affects their daily life on a 1-7 scale.

    12 weeks

  • Heart Rate Variability

    Measured using the Polar H10 sensor to evaluate autonomic nervous system activity during rest and activity.

    12 weeks

  • Trunk Flexor and Extensor Endurance Tests:

    Time-based static hold tests assessing core stabilization ability in flexion and extension positions.

    12 weeks

  • Plank Test

    Participant holds a forearm plank position, and the time until fatigue or form loss is recorded to assess core endurance.

    12 weeks

Study Arms (3)

Reformer Pilates

EXPERIMENTAL
Other: Reformer Pilates

Pilates control

ACTIVE COMPARATOR
Other: Pilates control

online pilates

ACTIVE COMPARATOR
Other: online pilates

Interventions

Reformer Pilates

Reformer Pilates

Pilates control

Pilates control

online pilates

online pilates

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Aged between 18 and 60 years
  • Non-specific low back pain for more than 12 weeks
  • No clear pathological diagnosis
  • Physically and cognitively capable of performing the exercises

You may not qualify if:

  • Pregnancy
  • Spinal surgery in the last 6 months
  • Neurological or chronic systemic diseases
  • Movement restriction due to severe pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hazal GENÇ

Istanbul, None Selected, 34353, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back PainMotor Activity

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 17, 2025

First Posted

April 24, 2025

Study Start

April 6, 2025

Primary Completion

June 6, 2025

Study Completion

July 7, 2025

Last Updated

August 12, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations