Physical EnduranceNCT04209335
Isometric Core Muscle Endurance in Healthy Active and Non-active Working Age Populations
A study testing isometric core muscle endurance testing in people with Physical Endurance, run by Hanna Holmberg at 1 site in United Kingdom.
Trial summary
Objectives: The purpose of this study was to investigate a possible correlation between core muscle endurance and participants' age in healthy adult population. Secondary purpose was to identify other dependent variables influencing isometric core muscle endurance (e.g. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Endurance
- What is being tested?
- isometric core muscle endurance testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2018to 10 Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 20-70 (working age population)
- healthy
- active and non-active
- with or without non-specific lower back pain
Who cannot join
- all serious pathologies and diagnosis that could affect the ability to perform the tests safely including acute pain, neurological, musculoskeletal, cardiovascular diseases, spinal pathologies (e.g. spondylitis, acute herniated disc, cauda equina, hypertension, epilepsy, tumour, previous fracture or surgery in trunk, structured deformity, osteoporosis)
- sudden change in health
- personal reasons
- severe pain during testing
- competing in any sports higher than amateur level
Trial locations and contacts
1 site in 1 country.
About this study
Objectives: The purpose of this study was to investigate a possible correlation between core muscle endurance and participants' age in healthy adult population. Secondary purpose was to identify other dependent variables influencing isometric core muscle endurance (e.g. low back pain, physical activity, gender, body mass index).
Methods: 48 (35 females, 13 males) healthy adults (aged 21-66 years) performed 4 isometric core muscle endurance tests- Biering-Sorensen, McGill V-sit, right and left side plank. A correlation between core endurance and age, gender, lower back pain (LBP), physical activity level (PAL), and body mass index (BMI) was calculated.
Read the detailed description
This is the first study to investigate the core muscle endurance of different age groups and genders with all four endurance tests of the core.
Since strength and endurance are key to keeping healthy as we age and National Institute for Health and Care Excellence (NICE) and European guidelines advocate them, this study aims to look at the 3 main measurements of core endurance namely flexor, extensor and lateral muscles, and the possible correlations with age, PAL, existence of LBP, BMI and gender. Each participant performed 4 isometric core endurance tests in the same order- 1. Biering-Sorensen, 2.-3. side plank on both sides, and 4. McGill V-sit. All participants were tested by the same tester to reduce potential differences in procedure and testing error. The four tests were each measured using a stopwatch and documented in seconds. Each participant was told the time they had reached during testing to improve their motivation. Pain during testing was documented.
Based on the normative data of abdominal muscle endurance for young adults Null hypothesis (H0)- There is no significant difference in endurance tests for age, presence of LBP or PAL. Hypothesis (H1)- Any significant difference in endurance tests for age, presence of LBP or PAL are due to chance factors. This is a two-tailed hypothesis, as previous evidence shows conflicting results. Pearson's correlation and Independent T-test in SPSS (The Statistical Package for the Social Sciences) were used to confirm or reject the possible correlations between the core muscle endurance and age, LBP, PAL, gender, BMI, and participants' job.
- Conditions
- Physical Endurance
- Being tested
- isometric core muscle endurance testing
- Keywords
- aging, lower back pain, physical activity level, body mass index, core muscle endurance, gender, McGill V-sit, Biering-Sorensen, sideplank
- Medical subject headings
- Low Back Pain, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isometric core muscle endurance testingOther
holding previously described isometric positions until fatigue
| Study group | Role | What they receive |
|---|---|---|
| healthy working age population | Other | isometric core muscle endurance tests (McGill V-sit, Biering-Sorensen and sideplank) Receives: Other: isometric core muscle endurance testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core Muscle Endurance
time in seconds after summing the results of all 4 tests
Measured: at the time of testing, in 1 hour
Secondary outcomes (3)
Body Mass Index
weight(kg)/height(cm)2 Value under 18.5 is considered underweight, over 25 overweight, and over 30 obese.
Measured: during the time of testing, in 1 h
Physical Activity Level Questionnaire
physical activity level based on national and international recommendations
Measured: at the time of testing, last 2 weeks
Number of Participants Who Have Experienced Non-specific Lower Back Pain
categorical data, experience of nonspecific low back pain up to 6 months before the assessment
Measured: up to 6 months before the assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start1 Jul 2018
- Primary completion1 Jun 2019
- Study completion10 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Physical EnduranceStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanna Holmberg
- Sponsor type
- University, hospital or other
- Collaborators
- University of Salford
- Responsible party
- Sponsor-investigator, Hanna Holmberg, University of Salford
- Investigators
- Lynne E Gaskell, MSc, Principal investigator, SupervisorHanna Holmberg, MSc, Principal investigator, student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04209335
- Sponsor's protocol ID
- HST 1718-316
- Status last verified
- Mar 2020
- First submitted
- 16 Dec 2019
- Last updated
- 23 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isometric Core Muscle Endurance in Healthy Active and Non-active Working Age Populations
- ClinicalTrials.gov ID
- NCT04209335
- Acronym / sponsor ID
- HST 1718-316
- Conditions
- Physical Endurance
- Keywords
- aging, lower back pain, physical activity level, body mass index, core muscle endurance, gender, McGill V-sit, Biering-Sorensen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hanna HolmbergUniversity, hospital or other
- Collaborators
- University of Salford
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 10 Sep 2019 (actual)
- First posted
- 24 Dec 2019 (actual)
- Results
- Posted 23 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives: The purpose of this study was to investigate a possible correlation between core muscle endurance and participants' age in healthy adult population. Secondary purpose was to identify other dependent variables influencing isometric core muscle endurance (e.g. low back pain, physical activity, gender, body mass index).
Methods: 48 (35 females, 13 males) healthy adults (aged 21-66 years) performed 4 isometric core muscle endurance tests- Biering-Sorensen, McGill V-sit, right and left side plank. A correlation between core endurance and age, gender, lower back pain (LBP), physical activity level (PAL), and body mass index (BMI) was calculated.
Detailed description
This is the first study to investigate the core muscle endurance of different age groups and genders with all four endurance tests of the core.
Since strength and endurance are key to keeping healthy as we age and National Institute for Health and Care Excellence (NICE) and European guidelines advocate them, this study aims to look at the 3 main measurements of core endurance namely flexor, extensor and lateral muscles, and the possible correlations with age, PAL, existence of LBP, BMI and gender. Each participant performed 4 isometric core endurance tests in the same order- 1. Biering-Sorensen, 2.-3. side plank on both sides, and 4. McGill V-sit. All participants were tested by the same tester to reduce potential differences in procedure and testing error. The four tests were each measured using a stopwatch and documented in seconds. Each participant was told the time they had reached during testing to improve their motivation. Pain during testing was documented.
Based on the normative data of abdominal muscle endurance for young adults Null hypothesis (H0)- There is no significant difference in endurance tests for age, presence of LBP or PAL. Hypothesis (H1)- Any significant difference in endurance tests for age, presence of LBP or PAL are due to chance factors. This is a two-tailed hypothesis, as previous evidence shows conflicting results. Pearson's correlation and Independent T-test in SPSS (The Statistical Package for the Social Sciences) were used to confirm or reject the possible correlations between the core muscle endurance and age, LBP, PAL, gender, BMI, and participants' job.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy working age population | Other | Other: isometric core muscle endurance testingisometric core muscle endurance tests (McGill V-sit, Biering-Sorensen and sideplank) |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged 20-70 (working age population)
- healthy
- active and non-active
- with or without non-specific lower back pain
Key exclusion criteria (5 listed)
- all serious pathologies and diagnosis that could affect the ability to perform the tests safely including acute pain, neurological, musculoskeletal, cardiovascular diseases, spinal pathologies (e.g. spondylitis, acute herniated disc, cauda equina, hypertension, epilepsy, tumour, previous fracture or surgery in trunk, structured deformity, osteoporosis)
- sudden change in health
- personal reasons
- severe pain during testing
- competing in any sports higher than amateur level
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 |
|---|---|---|
| isometric core muscle endurance testingholding previously described isometric positions until fatigue | Other | healthy working age population |
Primary outcome
Core Muscle Endurance
Time frame: at the time of testing, in 1 hour
time in seconds after summing the results of all 4 tests
3 secondary outcomes
Body Mass Index
Time frame: during the time of testing, in 1 h
Physical Activity Level Questionnaire
Time frame: at the time of testing, last 2 weeks
Number of Participants Who Have Experienced Non-specific Lower Back Pain
Time frame: up to 6 months before the assessment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Lynne E Gaskell, MSc principal investigator
Supervisor
Hanna Holmberg, MSc principal investigator
student
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing isometric core muscle endurance testing in people with Physical Endurance, run by Hanna Holmberg at 1 site in United Kingdom.
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 5 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 23 Mar 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 United Kingdom. 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?
Yes. Results are posted in the registry (first posted 23 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Core Muscle Endurance (time frame: at the time of testing, in 1 hour). 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 23 Mar 2020.