NCT04450615

Brief Summary

This study aims in investigating the effects of a core muscles' strengthening program on core muscles' atrophy and contraction ability. Twenty healthy adults recruited and randomly assigned to either a 5-week training group developed to activate and strengthen local trunk muscles or a control group. The training program includes isometric bridging exercises from various positions and dynamic exercises for lumbopelvic stability. Core muscles' thickness will be assessed at rest and contracting conditions, prior and after the intervention, using ultrasonography.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2020

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 25, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 29, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2020

Completed
Last Updated

November 10, 2020

Status Verified

November 1, 2020

Enrollment Period

2 months

First QC Date

June 25, 2020

Last Update Submit

November 9, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Transversus abdominis (TrA) muscle thickness at rest and contraction

    Muscle thickness (mm) is measured using ultrasonography

    Change from baseline assessment at 5 weeks

  • Lumbar multifidus (LM) muscle thickness at rest and contraction

    Muscle thickness (mm) is measured using ultrasonography

    Change from baseline assessment at 5 weeks

Secondary Outcomes (1)

  • Contraction thickness ratio (CTR) of TrA and LM muscle

    Change from baseline assessment at 5 weeks

Study Arms (2)

Training group

EXPERIMENTAL

The first part of the program aims in pelvic and hip mobility and includes the following exercises, glute bridge, single-leg glute bridge, side-lying clam, side plank and side plank with hip abduction, on stable surface. The second part consists of exercises for deep and superficial trunk muscles. In the first exercise the participants learn to activate the transversus abdominis muscle from the crook-lying position, by performing abdominal hollow. Other exercises include the front plank, trunk curl-up, trunk curl-up on stable surface and curl-up on unstable surface (Swiss ball). The third part of the program consists of exercises for strengthening the lumbar multifidus muscle. The participants will perform prone trunk extension, superman exercise, quadruped diagonal arm and leg lift, single leg supine bridge and supine bridge on unstable surface (Swiss ball).

Other: Core stability

Control group

NO INTERVENTION

The participants of this group will follow their typical daily routine

Interventions

The exercise protocol consists of the following sets and repetitions, with a total duration of 5 weeks and a frequency of 3 sessions per week. Dynamic exercises: 2 sets of 10 to 15 repetitions (each side) Isometric exercises: 2 sets of 5 to 15 seconds (each side) Week 1- As mentioned above Week 2- Add 1 set Week 3 - Add 5 seconds and 5 repetitions Week 4 - Add 1 set Week 5- Add 5 seconds and 5 repetitions

Training group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • to 45 years old
  • Trained recreationally at least 2 times a week, for the past 3 years
  • Healthy
  • No musculoskeletal injuries in the 6 months prior to the study

You may not qualify if:

  • History of chronic low back pain
  • History of hip, pelvic or low back surgery
  • History of acute low back pain with duration at least 1 week, the preceding 6 months
  • Involvement in similar core stability training programs the last 12 moths prior to this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory of Neuromechanics, Department of physical education and sport sciences, Aristotle University of Thessaloniki

Serres, 62110, Greece

Location

MeSH Terms

Conditions

Muscular AtrophyAsthenia

Interventions

Core Stability

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Postural BalanceProprioceptionVestibulocochlear Physiological PhenomenaPhysiological PhenomenaMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaSensationNervous System Physiological Phenomena

Study Officials

  • Athanasios Ellinoudis, PhD

    Laboratory of Neuromechanics, Aristotle University of Thessaloniki

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 25, 2020

First Posted

June 29, 2020

Study Start

May 20, 2020

Primary Completion

July 30, 2020

Study Completion

August 5, 2020

Last Updated

November 10, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations