NCT06340191

Brief Summary

The intervention involved two groups participating in supervised Pilates sessions, twice a week for 8 weeks, featuring a mix of mat and props-based exercises. Group 1 received additional cueing training to enhance alignment, muscle engagement, and movement technique, while Group 2 underwent the same Pilates regimen without this cueing component.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

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

Timeline
Completed

Started May 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2024

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2024

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 1, 2024

Completed
Last Updated

April 1, 2024

Status Verified

March 1, 2024

Enrollment Period

10 months

First QC Date

March 25, 2024

Last Update Submit

March 25, 2024

Conditions

Keywords

pilateslow back painmind-body

Outcome Measures

Primary Outcomes (2)

  • Low back pain

    Roland Morris Disability Questionnaire (RMDQ): The RMDQ is a self-reported measure widely used to assess physical disability due to lower back pain. It consists of 24 items that reflect the range of activities that might be affected by back pain. The scoring is simple, with higher scores indicating greater disability. This questionnaire is known for its reliability and validity in measuring disability levels in individuals with back pain

    From baseline to 8 weeks

  • Pain report

    Pain was measured using a visual analogue scale (VAS). The VAS consists of a 10-cm line, with the left extremity representing (the absence of pain) and the right extremity indicating (the worse pain devisable). Participants were asked to indicate on the scale their current level of pain being higher values related to more intense pain.

    From baseline to 8 weeks

Secondary Outcomes (5)

  • Fear of movement

    From baseline to 8 weeks

  • Perceived Stress Scale

    From baseline to 8 weeks

  • Pain self-efficacy

    From baseline to 8 weeks

  • Patient Impression of Change

    From baseline to 8 weeks

  • Body Awareness

    From baseline to 8 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

Pilates in addition to cueing

Other: Pilates with cueing

Control group

ACTIVE COMPARATOR

Pilates without cueing

Other: Pilates without cueing

Interventions

The Pilates with a cueing component of the intervention involved a specialized approach to Pilates training. Participants in this group underwent an initial phase of training before the main sessions began, which consisted of two smaller group sessions focused on learning explicit verbal and tactile cues. These cues were designed to assist participants in maintaining proper body alignment, engaging specific muscle groups more effectively, and refining their movement techniques to enhance the overall efficacy of the Pilates exercises. During the actual Pilates sessions, the instructors, who were certified and brought extensive experience to the program, provided real-time feedback to the participants. This feedback was based on the cueing instructions, aiming to optimize the execution of the Pilates exercises.

Intervention group

The Pilates without cueing portion of the study involved participants following the same comprehensive Pilates program as the Pilates with cueing group, with a significant distinction: they did not receive any additional training on cueing. This group engaged in 60-minute Pilates sessions twice a week for 8 weeks, under the supervision of certified and highly experienced Pilates instructors. The program included a variety of exercises, both mat-based and utilizing props, designed to improve participants\' physical condition and wellness. However, unlike their counterparts in the first group, these participants were not given explicit instructions on how to enhance their body alignment, muscle engagement, or movement techniques through verbal and tactile cues. They performed the Pilates exercises following the standard regimen, without the nuanced guidance and real-time feedback focused on optimizing exercise execution through cueing.

Control group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals aged 18 to 65 years.
  • Experiencing chronic non-specific low back pain for a minimum of 3 months.
  • Ability to participate in supervised exercise programs.
  • Absence of medical contraindications for Pilates practice.

You may not qualify if:

  • Vestibular disorders.
  • Severe osteoporosis.
  • Usual Pilates practitioner.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Jaen

Jaén, 23071, Spain

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • DAVID CRUZ DIAZ, PhD

    University of Jaén

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 25, 2024

First Posted

April 1, 2024

Study Start

May 2, 2023

Primary Completion

February 20, 2024

Study Completion

February 26, 2024

Last Updated

April 1, 2024

Record last verified: 2024-03

Locations