NCT07261020

Brief Summary

The aim of the study was to compare the effects of reformer pilates and mat exercise on pain, quality of life and kinesiophobia in female patients with lumbar disc herniation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

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

January 5, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2024

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 3, 2025

Completed
Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

2 months

First QC Date

November 21, 2025

Last Update Submit

December 19, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • quality of life scale short form

    The scale assessing quality of life consists of 36 questions. It rates health on a scale of 0 to 100, with 0 indicating poor health and 100 indicating good health.

    10 weeks

  • Tampa Kinesiophobia Scale

    The scale consists of 17 questions. It includes parameters for injury/re-injury and fear-avoidance in work-related activities. Each question is scored using a 4-point Likert scale (1 = strongly disagree, 4 = strongly agree). A total score is calculated by reverse-scoring questions 4, 8, 12, and 16. A higher score is interpreted as indicating a higher level of kinesiophobia.

    10 weeks

Study Arms (2)

mat exercise group

EXPERIMENTAL

mat pilates exercise

Other: mat pilates

reformer exercise group

EXPERIMENTAL

reformer pilates exercise

Other: reformer pilates

Interventions

The mat pilates group was given an exercise program consisting of 16 sessions, 2 days a week, for 8 weeks. All exercises were performed as one set of 15 repetitions for the first 2 weeks, 15 repetitions for the 3rd and 4th weeks, and 15 repetitions for the 5th and 6th weeks, with 20 repetitions for the final 2 weeks. Exercise intensity (number of repetitions and level of movement) was gradually increased. Priority was given to core muscles when selecting exercises. The aim was to work the transversus abdominis, multifidus, and gluteus muscles both eccentrically and concentrically, while maintaining spinal stabilization and fostering awareness during movement. The exercise protocol was performed twice a week for 8 weeks, with each session lasting 45 minutes.

mat exercise group

The Reformer Pilates group was assigned an exercise program consisting of 16 sessions, 2 days a week, for 8 weeks. All exercises were performed as one set of 15 repetitions for the first 2 weeks, 15 repetitions for the 3rd and 4th weeks, and 20 repetitions for the 5th and 6th weeks. Exercise intensity (number of repetitions and level of movement) was gradually increased. Priority was given to core muscles when selecting exercises. The aim was to work the transversus abdominis, multifidus, and gluteus muscles both eccentrically and concentrically, while maintaining spinal stabilization and fostering awareness during movement. The exercise protocol consisted of 45-minute sessions, 2 days a week, for 8 weeks.

reformer exercise group

Eligibility Criteria

Age25 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being between 25 and 60 years of age
  • Having been diagnosed with a lumbar disc herniation
  • Having agreed to participate in the study

You may not qualify if:

  • Being outside the specified age limits
  • Having an orthopedic, neurological, or other condition that prevents exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fone Physio Healthy Living Center

Istanbul, Kadıköy, Turkey (Türkiye)

Location

Related Publications (3)

  • Franks J, Thwaites C, Morris ME. Pilates to Improve Core Muscle Activation in Chronic Low Back Pain: A Systematic Review. Healthcare (Basel). 2023 May 12;11(10):1404. doi: 10.3390/healthcare11101404.

    PMID: 37239690BACKGROUND
  • Li Y, Yan L, Hou L, Zhang X, Zhao H, Yan C, Li X, Li Y, Chen X, Ding X. Exercise intervention for patients with chronic low back pain: a systematic review and network meta-analysis. Front Public Health. 2023 Nov 17;11:1155225. doi: 10.3389/fpubh.2023.1155225. eCollection 2023.

    PMID: 38035307BACKGROUND
  • Fernandez-Rodriguez R, Alvarez-Bueno C, Cavero-Redondo I, Torres-Costoso A, Pozuelo-Carrascosa DP, Reina-Gutierrez S, Pascual-Morena C, Martinez-Vizcaino V. Best Exercise Options for Reducing Pain and Disability in Adults With Chronic Low Back Pain: Pilates, Strength, Core-Based, and Mind-Body. A Network Meta-analysis. J Orthop Sports Phys Ther. 2022 Aug;52(8):505-521. doi: 10.2519/jospt.2022.10671. Epub 2022 Jun 19.

    PMID: 35722759BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc DisplacementKinesiophobiaLow Back Pain

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPhobic DisordersAnxiety DisordersMental DisordersBack PainPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Ayça Bilgi

    Uskudar University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc.Prof.Dr.

Study Record Dates

First Submitted

November 21, 2025

First Posted

December 3, 2025

Study Start

January 5, 2024

Primary Completion

March 15, 2024

Study Completion

May 10, 2024

Last Updated

December 29, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations