HealthyNCT04477915
Effects of Two Different Exercise Practices on Maximum Oxygen Uptake and Pulmonary Function
A study testing Core exercises and Auxiliary respiratory exercises in people with Healthy, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial summary
Cardiopulmonary capacities of individuals are an indication of both the individual's exercise capacity and endurance. The most important indicator of cardiopulmonary capacity is maximum oxygen uptake and respiratory parameters. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Core exercises and Auxiliary respiratory exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jul 2020to 31 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy individuals without any known health problems
Who cannot join
- Acute myocardial infarction, Unstable angina, Uncontrolled cardiac arrhythmias, Endocarditis, Various symptomatic aortic stenosis, Acute pulmonary embolism, pulmonary infarction and deep vein thrombosis, Acute myocarditis, pericarditis, physically not enough fit to test safely
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Auxiliary Respiratory Muscles Exercises and Core Stabilization Exercises on Maximum Oxygen Uptake and Pulmonary Function
Cardiopulmonary capacities of individuals are an indication of both the individual's exercise capacity and endurance. The most important indicator of cardiopulmonary capacity is maximum oxygen uptake and respiratory parameters. Auxiliary respiratory muscles exercises and core stabilization exercises have a place in increasing the maximum oxygen uptake. There are studies investigating the effects of respiratory muscle training and core stabilization training on maximum oxygen uptake in the literature. However, there is no study in the literature comparing the effects of auxiliary respiratory muscles exercises and core stabilization exercises on maximum oxygen uptake and respiratory parameters. Thanks to the findings to be obtained from our study, it is aimed to contribute to the literature with objective, evidence-based results in this field.
Read the detailed description
The study will be carried out on volunteers after the approval of the ethics committee. Before the research, individuals and / or their relatives will be informed about the purpose and content of the study. Volunteer individuals between the ages of 18-25 without any known health problems will be included in the study after obtaining their informed consent.
Participants will be randomly divided into three groups: control group, core stabilization exercises and auxiliary respiratory muscles exercises.
In the core stabilization exercises and auxiliary respiratory muscles exercises groups, exercises will be carried out under the supervision of a physiotherapist 3 days in a week separate time periods. Core stabilization exercise include, plank, lateral plank, swimmer, flutter kick and bridge exercises. Auxiliary respiratory exercises include, strengthening and stretching exercises for trapezius, sternocleidomastoideus, pectoralis major and serratus anterior muscles. Our study will take 6 weeks. The demographic information of the participants will be recorded and the VO2max values of the participants before and after the study will be measured with the H / P Cosmos Mercury Med device using the balke protocol. Respiratory function tests of participants will be measured with Cosmed Fitmate Med device before and after the study.
- Conditions
- Healthy
- Being tested
- Core exercises, Auxiliary respiratory exercises
- Keywords
- Core stabilization, Auxiliary Respiratory Muscles, Maximum oxygen uptake, Pulmonary function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core exercisesOther
Core stabilization exercise include, plank, lateral plank, swimmer, flutter kick and bridge exercises.
Auxiliary respiratory exercisesOther
Auxiliary respiratory exercises include, strengthening and stretching exercises for trapezius, sternocleidomastoideus, pectoralis major and serratus anterior muscles.
| Study group | Role | What they receive |
|---|---|---|
| Core stabilization Exercise | Experimental | Core stabilization exercise include, plank, lateral plank, swimmer, flutter kick and bridge exercises. Exercises will be carried out under the supervision of a physiotherapist 3 days in a week separate time periods. Our study will take 6 weeks. Receives: Other: Core exercises |
| Auxiliary respiratory exercises | Experimental | Auxiliary respiratory exercises include, strengthening and stretching exercises for trapezius, sternocleidomastoideus, pectoralis major and serratus anterior muscles. exercises will be carried out under the supervision of a physiotherapist 3 days in a week separate time periods. Our study will take 6 weeks. Receives: Other: Auxiliary respiratory exercises |
| Control | No intervention | Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Maximum oxygen uptake at 6 weeks
the VO2max values of the participants before and after the study will be measured with the H / P Cosmos Mercury Med device using the Balke Ware protocol.
Measured: Baseline and week 6
Change from baseline in Pulmonary function tests at 6 weeks
Forced expiratory volume in 1 second / forced vital capacity (FEV1/FVC), vital capacity and maximum voluntary ventilation (MVV) values of the participants will be measured with Cosmed Fitmate Med device before and after the study.
Measured: Baseline and week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start30 Jul 2020
- Primary completion25 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hasan Gerçek, Principal investigator, KTO Karatay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04477915
- Sponsor's protocol ID
- KaratayUH
- Status last verified
- Jul 2020
- First submitted
- 14 Jul 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Auxiliary Respiratory Muscles Exercises and Core Stabilization Exercises on Maximum Oxygen Uptake and Pulmonary Function
- ClinicalTrials.gov ID
- NCT04477915
- Acronym / sponsor ID
- KaratayUH
- Conditions
- Healthy
- Keywords
- Core stabilization, Auxiliary Respiratory Muscles, Maximum oxygen uptake, Pulmonary function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 30 Jul 2020 (actual)
- Primary completion
- 25 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 20 Jul 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.
Cardiopulmonary capacities of individuals are an indication of both the individual's exercise capacity and endurance. The most important indicator of cardiopulmonary capacity is maximum oxygen uptake and respiratory parameters. Auxiliary respiratory muscles exercises and core stabilization exercises have a place in increasing the maximum oxygen uptake. There are studies investigating the effects of respiratory muscle training and core stabilization training on maximum oxygen uptake in the literature. However, there is no study in the literature comparing the effects of auxiliary respiratory muscles exercises and core stabilization exercises on maximum oxygen uptake and respiratory parameters. Thanks to the findings to be obtained from our study, it is aimed to contribute to the literature with objective, evidence-based results in this field.
Detailed description
The study will be carried out on volunteers after the approval of the ethics committee. Before the research, individuals and / or their relatives will be informed about the purpose and content of the study. Volunteer individuals between the ages of 18-25 without any known health problems will be included in the study after obtaining their informed consent.
Participants will be randomly divided into three groups: control group, core stabilization exercises and auxiliary respiratory muscles exercises.
In the core stabilization exercises and auxiliary respiratory muscles exercises groups, exercises will be carried out under the supervision of a physiotherapist 3 days in a week separate time periods. Core stabilization exercise include, plank, lateral plank, swimmer, flutter kick and bridge exercises. Auxiliary respiratory exercises include, strengthening and stretching exercises for trapezius, sternocleidomastoideus, pectoralis major and serratus anterior muscles. Our study will take 6 weeks. The demographic information of the participants will be recorded and the VO2max values of the participants before and after the study will be measured with the H / P Cosmos Mercury Med device using the balke protocol. Respiratory function tests of participants will be measured with Cosmed Fitmate Med device before and after the study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Core stabilization Exercise | Experimental | Other: Core exercisesCore stabilization exercise include, plank, lateral plank, swimmer, flutter kick and bridge exercises. Exercises will be carried out under the supervision of a physiotherapist 3 days in a week separate time periods. Our study will take 6 weeks. |
| Auxiliary respiratory exercises | Experimental | Other: Auxiliary respiratory exercisesAuxiliary respiratory exercises include, strengthening and stretching exercises for trapezius, sternocleidomastoideus, pectoralis major and serratus anterior muscles. exercises will be carried out under the supervision of a physiotherapist 3 days in a week separate time periods. Our study will take 6 weeks. |
| Control | No intervention | –Control Group |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy individuals without any known health problems
Key exclusion criteria (1 listed)
- Acute myocardial infarction, Unstable angina, Uncontrolled cardiac arrhythmias, Endocarditis, Various symptomatic aortic stenosis, Acute pulmonary embolism, pulmonary infarction and deep vein thrombosis, Acute myocarditis, pericarditis, physically not enough fit to test safely
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 exercisesCore stabilization exercise include, plank, lateral plank, swimmer, flutter kick and bridge exercises. | Other | Core stabilization Exercise |
| Auxiliary respiratory exercisesAuxiliary respiratory exercises include, strengthening and stretching exercises for trapezius, sternocleidomastoideus, pectoralis major and serratus anterior muscles. | Other | Auxiliary respiratory exercises |
Primary outcome
Change from baseline in Maximum oxygen uptake at 6 weeks
Time frame: Baseline and week 6
the VO2max values of the participants before and after the study will be measured with the H / P Cosmos Mercury Med device using the Balke Ware protocol.
Change from baseline in Pulmonary function tests at 6 weeks
Time frame: Baseline and week 6
Forced expiratory volume in 1 second / forced vital capacity (FEV1/FVC), vital capacity and maximum voluntary ventilation (MVV) values of the participants will be measured with Cosmed Fitmate Med device before and after the study.
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 14 Oct 2020.
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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.
Hasan Gerçek principal investigator
KTO Karatay University
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 exercises and Auxiliary respiratory exercises in people with Healthy, run by KTO Karatay University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 14 Oct 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 Turkey (Türkiye). 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?
Change from baseline in Maximum oxygen uptake at 6 weeks (time frame: Baseline and week 6). 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 14 Oct 2020.