Condition category
Musculoskeletal Diseases
Date applied
22/06/2020
Date assigned
30/07/2020
Last edited
30/07/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Trunk rotations are important functional movements which form the foundations of the human motion pattern, especially in the functions of walking and running. The aim of this study is to assess how different kinds of core training improve abdominal muscle thickness, spinal range of motion, muscle power and muscle stiffness.

Who can participate?
Healthy people aged 18 - 45 years

What does the study involve?
The whole experiment will last for about 6-7 weeks. Every participant will go through a specific examination, including an interview, warm-up, functional tests, and self-made questionnaires. It will take up to 90 minutes. After that, patients will be randomly assigned to one out of three groups: two experimental groups provided with a specific training programme (local and global movement patterns), and one control group (without any training). The examination will be done at three times: on the first day (before training starts), after 4 weeks, and 2 weeks after the last training session. The study will include and assess two training concepts that develop central stabilization. The first group will focus on isolated transversus abdominis (TrA) muscle work and are taught how to do it. As soon as patients from the first group learn how to contract TrA (lying on their back), they will perform a specific training, including gentle breathing and moving upper and lower limbs. The same procedure will be repeated when sitting, standing, dynamic movements and walking. Training will be carried under the control of two physiotherapists. One of them will focus on providing cues, so the patient will perform movements properly, while the second therapist will perform feedback. Every patient will be treated individually. Training will last for 45-60 minutes. Patients from the second experimental group will also perform central stabilization training, but it will be based on global movements without isolated contraction of the so-called "core muscles". Patients will train under the control of two physiotherapists. One of them will be a strength and conditioning coach. Patients will perform a back-bridge, side-bridge, plank, quadruped, and torso rotations lying on their back. All exercises will be modified to increase or decrease difficulty and breathing will be underlined. Patients will train in a room with mirrors, so they will be able to visually control their movements. Training will last for 45-60 minutes. Patients from both groups will train four times a week for 4 weeks.

What are the possible benefits and risks of participating?
Participants may have better stability. The researchers think that there is no risk of participating.

Where is the study run from?
Medical University of Silesia (Poland)

When is the study starting and how long is it expected to run for?
January 2015 to September 2020

Who is funding the study?
The Jerzy Kukuczka Academy of Physical Education (Poland)

Who is the main contact?
Dr n. o zdr. Katarzyna Szuścik-Niewiadomy
kszuscik@sum.edu.pl

Trial website

Contact information

Type

Public

Primary contact

Dr Katarzyna Szuścik-Niewiadomy

ORCID ID

http://orcid.org/0000-0002-2260-2614

Contact details

Zakład Adaptowanej Aktywności Fizycznej i Sportu Katedry Fizjoterapii
Śląski Uniwersytet Medyczny w Katowicach
ul. Medyków 12
Katowice
40-752
Poland
+48 (0)32 20 88 749
kszuscik@sum.edu.pl

Type

Scientific

Additional contact

Dr Katarzyna Szuścik-Niewiadomy

ORCID ID

Contact details

Zakład Adaptowanej Aktywności Fizycznej i Sportu Katedry Fizjoterapii
Śląski Uniwersytet Medyczny w Katowicach
ul. Medyków 12
Katowice
40-752
Poland
+48 (0)32 20 88 749
kszuscik@sum.edu.pl

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

KNW/0022/KB1/12/15

Study information

Scientific title

Assessment of the influence of core stability training on selected functional and structural parameters among young healthy people

Acronym

Study hypothesis

Do different stability trainings improve muscle thickness, spinal range of motion, muscle power, muscle stiffness?

Ethics approval

Approved 10/02/2015, Ethics Committee of Medical University of Silesia (Poniatowskiego 15, 40-055 Katowice; +48 (0)32 208 35 46; kombioet@sum.edu.pl), ref: KNW/0022/KB1/12/15

Study design

Double-blinded randomized control trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details to request a participant information sheet

Condition

Effects of core muscle training in healthy adults

Intervention

The whole experiment will last for about 6-7 weeks. Every participant will go through a specific examination, including an interview, warm-up, functional tests, and self-made questionnaires. It will take up to 90 minutes. After that, patients will be randomly assigned to one out of three groups: two experimental groups provided with a specific training programme (local and global movement patterns), and one control group (without any training). The examination will be done at three times: on the 1st day (before training starts), after 4 weeks, and 2 weeks after the last training session. The study will include and assess two training concepts that develop central stabilization. The first group will focus on isolated transversus abdominis muscle work and are taught (using palpation and USG-feedback method) how to do it. As soon as patients from the first group learn how to contract TrA (laying on their back), they will perform a specific training, including gentle breathing and moving upper and lower limbs. The same procedure will be repeated in sitting, standing, dynamic movements and walking. Training will be carried under the control of two physiotherapists. One of them will focus on providing cues, so the patient will perform movements properly, while the second therapist will perform a USG-feedback. Every patient will be treated individually. Training will last for 45-60 minutes. Patients from the second experimental group will also perform a central stabilization training, but it will be based on global movements without isolated contraction of the so-called "core muscles". Patients will train under the control of two physiotherapists. One of them will be a strength and conditioning coach. Patients will perform a back-bridge, side-bridge, plank, quadruped, and torso rotations lying on their back. All exercises will be modified to increase or decrease difficulty and breathing will be underlined. Patients will train in room with mirrors, so they will be able to visually control their movements. Training will last for 45-60 minutes. Patients from both groups will train four times a week for 4 weeks.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Measured on the 1st day (before training starts), after 4 weeks, and 2 weeks after the last training session (6 weeks after starting the experiment):
1. Muscle thickness measured using USG - Edan DUS 60 with linear transducer
2. Range of motion measured using inclinometer
3. Force applied during passive muscle stiffness testing measured using electronic dynamometer
4. Pain levels from last 7 days measured using McGill Pain Questionnaire Short-Form SF-MPQ

Secondary outcome measures

Measured on the 1st day (before training starts), after 4 weeks, and 2 weeks after the last training session (6 weeks after starting the experiment):
1. Body composition measured using Tanita body composition analyzer
2. Body fat measured using mechanical caliper
3. Distance in Thomayer’s test measured using self-made platform
4. Distance in modified Thomayer’s test (heel added) measured using FMS platform
5. Pain levels at a given moment, its change and its influence on the ability to perform daily activities, measured using Revised Oswestry Low Back Pain Disability Scale
6. Level of physical activity measured using International Physical Activity Questionnaire (IPAQ)

Overall trial start date

01/01/2015

Overall trial end date

01/10/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Age 18 - 45 years
2. BMI less than 30 kg/m²

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

120

Participant exclusion criteria

1. Pain in the spine higher than 7/10 VAS
2. Neurologic symptoms
3. Abdominal surgery interventions in the past
4. Pregnancy
5. Chronic diseases
6. Pharmacotherapy

Recruitment start date

31/07/2020

Recruitment end date

15/08/2020

Locations

Countries of recruitment

Poland

Trial participating centre

Medical University of Silesia
Medyków 12
Katowice
40-752
Poland

Sponsor information

Organisation

The Jerzy Kukuczka Academy of Physical Education

Sponsor details

Mikołowska 72A
Katowice
40-065
Poland
+48 (0)32 207 51 10
rektorat@awf.katowice.pl

Sponsor type

University/education

Website

https://www.awf.katowice.pl/

Funders

Funder type

University/education

Funder name

The Jerzy Kukuczka Academy of Physical Education in Katowice

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

Intention to publish date

01/10/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

30/06/2020: Trial's existence confirmed by Ethics Committee of Medical University of Silesia.