Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04450615
Other study ID # ERC-006/2020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 20, 2020
Est. completion date August 5, 2020

Study information

Verified date November 2020
Source Aristotle University Of Thessaloniki
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

A total of 136 male and female adults, members of local gyms, were initially invited for participation in the study after giving their written consent. After a second contact with the participants, forms regarding the inclusion and exclusion criteria were sent for completion. Of the 136 that initially answered positively for participation, 62 did not meet the inclusion criteria, based on their reports and the clinical examination by a health professional. Of the remaining 74 participants, 32 were excluded because of previous low back pain incidents and other recent musculoskeletal injuries that led to rehabilitation, while 22 decided to not participate for personal reasons. The remaining 20 participants were randomly allocated to either training group or intervention group, by a neutral, blinded investigator who had no involvement and was unaware of the study purposes. The intervention group will be trained and supervised by a certified fitness instructor in a gym class, who will be responsible for the correct execution of the exercises. The duration of the intervention will be 5 weeks, 3 times a week.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date August 5, 2020
Est. primary completion date July 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - 18 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 Exclusion Criteria: - 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

Study Design


Intervention

Other:
Core stability
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

Locations

Country Name City State
Greece Laboratory of Neuromechanics, Department of physical education and sport sciences, Aristotle University of Thessaloniki Serres

Sponsors (1)

Lead Sponsor Collaborator
Athanasios Ellinoudis

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Primary Transversus abdominis (TrA) muscle thickness at rest and contraction Muscle thickness (mm) is measured using ultrasonography Change from baseline assessment at 5 weeks
Primary Lumbar multifidus (LM) muscle thickness at rest and contraction Muscle thickness (mm) is measured using ultrasonography Change from baseline assessment at 5 weeks
Secondary Contraction thickness ratio (CTR) of TrA and LM muscle This is calculated by subtracting rest thickness from contraction thickness, dividing it to rest thickness and multiplying this value by 100 [(contraction thickness-rest thickness/rest thickness)*100] Change from baseline assessment at 5 weeks
See also
  Status Clinical Trial Phase
Completed NCT06034756 - Temporomandibular Joint Problems and Core Stabilization
Completed NCT05205278 - Effect of Progressive Isolated Core Stability Training N/A
Recruiting NCT06131138 - Aquatic Exercises VS Core Strengthening on Disability, Flexibility and Postural Stability in Weightlifters. N/A
Completed NCT05711069 - Core Stabilization Programme on Kicking Velocity and Performance in Male Adolescent Football Players N/A
Completed NCT04823936 - Core Stability in Ataxic Cerebral Palsied Children N/A
Completed NCT04928833 - Investigation of the Effects of Pilates Training in Parkinson Patients N/A
Recruiting NCT05719532 - Core Strength and Coordinative Skills
Completed NCT03459430 - Chronic Effect of Individualized Core Stability Programs in Recreational Athletes. N/A
Recruiting NCT06203340 - Lumbar School Training or Core Stabilization Exercises on Pain, Mobilization and Quality of Life Low Back Pain N/A
Completed NCT06142110 - The Relationship Between Functional Movement and Respiratory Muscle Strength N/A
Completed NCT04220385 - Comparison Between the Effectiveness of Wii Fit Plus and Core Exercise Program in Improving Core Stability in Adults N/A
Completed NCT04801212 - The Effects of Lumbar Stabilization Exercises With and Without Jaw Movements in Non-specific Low Back Pain. N/A