Muscle Atrophy or WeaknessNCT04450615
Core Exercises Effects on Muscle Imbalances
A study testing Core stability in people with Muscle Atrophy or Weakness and Muscle Contraction, run by Athanasios Ellinoudis at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Atrophy or Weakness, Muscle Contraction, Core Stability
- What is being tested?
- Core stability
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGreece
- Study dates
- 20 May 2020to 5 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Greece1 site
Laboratory of Neuromechanics, Department of physical education and sport sciences, Aristotle University of Thessaloniki
Serres, 62110
About this study
Official title: Effects of a 5-week Core Training Program on Core Muscles' Imbalances
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.
Read the detailed 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.
- Being tested
- Core stability
- Medical subject headings
- Muscular Atrophy, Asthenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core stabilityOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Core stability |
| Control group | No intervention | The participants of this group will follow their typical daily routine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transversus abdominis (TrA) muscle thickness at rest and contraction
Muscle thickness (mm) is measured using ultrasonography
Measured: Change from baseline assessment at 5 weeks
Lumbar multifidus (LM) muscle thickness at rest and contraction
Muscle thickness (mm) is measured using ultrasonography
Measured: Change from baseline assessment at 5 weeks
Secondary outcomes (1)
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]
Measured: Change from baseline assessment at 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start20 May 2020
- Primary completion30 Jul 2020
- Study completion5 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Atrophy or WeaknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Athanasios Ellinoudis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Athanasios Ellinoudis, Aristotle University Of Thessaloniki
- Investigators
- Athanasios Ellinoudis, PhD, Principal investigator, Laboratory of Neuromechanics, Aristotle University of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04450615
- Sponsor's protocol ID
- ERC-006/2020
- Status last verified
- Nov 2020
- First submitted
- 25 Jun 2020
- Last updated
- 10 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a 5-week Core Training Program on Core Muscles' Imbalances
- ClinicalTrials.gov ID
- NCT04450615
- Acronym / sponsor ID
- ERC-006/2020
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Athanasios EllinoudisUniversity, hospital or other
- Study start
- 20 May 2020 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 5 Aug 2020 (actual)
- First posted
- 29 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training group | Experimental | Other: Core stabilityThe 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). |
| Control group | No intervention | –The participants of this group will follow their typical daily routine |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Core stabilityThe 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 | Other | Training group |
Primary outcome
Transversus abdominis (TrA) muscle thickness at rest and contraction
Time frame: Change from baseline assessment at 5 weeks
Muscle thickness (mm) is measured using ultrasonography
Lumbar multifidus (LM) muscle thickness at rest and contraction
Time frame: Change from baseline assessment at 5 weeks
Muscle thickness (mm) is measured using ultrasonography
1 secondary outcome
Contraction thickness ratio (CTR) of TrA and LM muscle
Time frame: Change from baseline assessment at 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Athanasios Ellinoudis, PhD principal investigator
Laboratory of Neuromechanics, Aristotle University of Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core stability in people with Muscle Atrophy or Weakness and Muscle Contraction, run by Athanasios Ellinoudis at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transversus abdominis (TrA) muscle thickness at rest and contraction (time frame: Change from baseline assessment at 5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.