NCT06672809

Brief Summary

This study investigates the effects of core stability training on the functionality and control of deep stabilizing muscles in healthy adults. Core stability exercises focus on strengthening the transversus abdominis and related core muscles to prevent and manage low back pain. Participants are randomly assigned to either the experimental group, performing core stability exercises on unstable surfaces such as a reformer, or the control group, performing aerobic exercises. Outcomes are measured by changes in muscle thickness and contraction time using rehabilitative ultrasound imaging, aiming to demonstrate the potential of core stabilization for enhancing spine support and reducing lower back pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 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

First Submitted

Initial submission to the registry

November 1, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 4, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

November 4, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2025

Completed
Last Updated

January 15, 2025

Status Verified

January 1, 2025

Enrollment Period

2 months

First QC Date

November 1, 2024

Last Update Submit

January 14, 2025

Conditions

Keywords

Core StabilityDeep Stabilizing MusclesMuscle ActivationRehabilitation

Outcome Measures

Primary Outcomes (2)

  • Thickness of Deep Stabilizing Muscles

    The thickness of the core stabilizing muscles, including the rectus abdominis, transversus abdominis, internal oblique, and external oblique, is measured using rehabilitative ultrasound imaging (RUSI). For this assessment, a 10 MHz linear probe or a 3.5 MHz convex probe is positioned 2.5 cm lateral to the umbilicus while the participant lies in a supine position. The measurement captures the distance between the upper and lower fascial layers of each muscle, providing an indication of muscle thickness. Three measurements are taken, and the median value is used in analysis.

    Baseline and 8 weeks after the intervention

  • Contraction Time of Deep Stabilizing Muscles

    This measure assesses the contraction time of deep stabilizing muscles, specifically during a hollowing exercise where the participant engages the transversus abdominis and other abdominal muscles. Using rehabilitative ultrasound imaging (RUSI), the probe is positioned 2.5 cm lateral to the umbilicus to observe muscle activation. Contraction time is recorded as the duration from the onset of muscle activation to full contraction. Measurements are taken three times, with the median value used for analysis.

    Baseline and 8 weeks after the intervention

Study Arms (2)

Core Stability Training Group

EXPERIMENTAL

This group receives core stability training aimed at strengthening deep stabilizing muscles, including the transversus abdominis, to improve lumbar support and control. Participants perform a 50-minute session three times per week over eight weeks, focusing on exercises using unstable surfaces like the Pilates reformer to enhance proprioception and core engagement.

Behavioral: Core Stability Training

Control Group

ACTIVE COMPARATOR

This group participates in aerobic exercise sessions as a comparative intervention. Participants engage in a 50-minute session three times per week over eight weeks. The exercise includes warm-up, a main session (walking at a controlled intensity), and cool-down, with intensity levels adjusted over time to match cardiovascular improvements.

Behavioral: Aerobic Exercise

Interventions

Participants in this group undergo core stability training sessions targeting deep stabilizing muscles. The exercises are designed to enhance spinal support and core control by activating the transversus abdominis and other core muscles. Sessions involve the use of a Pilates reformer and other unstable surfaces, fostering proprioceptive engagement and improved muscle coordination. Training is conducted three times per week for eight weeks, with each session lasting 50 minutes.

Core Stability Training Group

Participants in this group engage in aerobic exercise sessions that consist of warm-up, controlled-intensity walking, and a cool-down phase. This intervention serves as a comparative baseline, aiming to improve cardiovascular endurance without specifically targeting core stability. The aerobic routine is adjusted over time to increase exercise intensity, conducted three times per week for eight weeks, with each session lasting 50 minutes.

Control Group

Eligibility Criteria

Age20 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged between 20 and 29 years
  • Healthy adults who can understand and complete the planned training program
  • Individuals who have signed informed consent to participate in the study

You may not qualify if:

  • Individuals with balance disorders due to orthopedic or neurological conditions
  • Those with cardiopulmonary diseases
  • Individuals who have undergone surgery within the past 6 months
  • Persons with other physical disabilities that could interfere with the study
  • Individuals who have participated in similar studies recently
  • Pregnant individuals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Therapy, Kyungdong University

Wŏnju, Gangwon-do, 26495, South Korea

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The evaluators were blinded to the intervention details of the participants.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

November 1, 2024

First Posted

November 4, 2024

Study Start

November 4, 2024

Primary Completion

January 10, 2025

Study Completion

January 10, 2025

Last Updated

January 15, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations