Health Young IndividualsNCT05934240
The Immediate Effect of Manual Therapy Application on Respiratory Functions in Healthy Young Individuals
A study testing Manual therapy group in people with Health Young Individuals, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Manual therapy techniques targeting the thoracic region are commonly used in clinical practice. It has been suggested that manual therapy interventions directed at the spine can increase mobility of the spine and chest wall, which may have a positive impact on lung functions. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Young Individuals
- What is being tested?
- Manual therapy group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2023to 15 Aug 2023
- 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
- be between the ages of 18-25,
- to be a studen
Who cannot join
- those who have any health problems
- those with orthopedic disorders
- those with systemic and cardiopulmonary diseases that would interfere with the evaluation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Immediate Effect of Manual Therapy Application on Respiratory Functions in Healthy
Manual therapy techniques targeting the thoracic region are commonly used in clinical practice. It has been suggested that manual therapy interventions directed at the spine can increase mobility of the spine and chest wall, which may have a positive impact on lung functions. The potential positive effects of thoracic manipulation on respiratory system diseases such as chronic obstructive pulmonary disease (COPD) and asthma have been investigated and continue to be studied. Specifically, the results of studies investigating the physiological outcomes of this therapeutic approach in healthy adults are conflicting. The aim of this study is to investigate the short-term effects of thoracic manipulation and mobilization, as well as diaphragm mobilization, through a single session of manual therapy interventions on respiratory functions.
Read the detailed description
In this planned study, designed as a randomized controlled intervention trial, two groups will be formed: an experimental group and a control group. After completing these procedures, the intervention group will receive the method of "thoracic mobilization and manipulation with diaphragm mobilization," while the control group will receive a placebo thoracic mobilization method. All techniques will be applied by a physiotherapist.
Within 5 minutes after the completion of the intervention, a respiratory function test will be repeated, resulting in a total of two respiratory function tests: one before the intervention and one after the intervention. The changes in respiratory function criteria before and after the intervention will be compared in both groups
- Conditions
- Health Young Individuals
- Being tested
- Manual therapy group, Sham-manual therapy
- Keywords
- Manual therapy, Respiratory function test, Physical activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual therapy groupOther
Manual therapy will be applied to the diaphragm and thoracic region.
Sham-manual therapyOther
Sham-manual therapy will be applied to the diaphragm and thoracic region.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Active comparator | Diaphragmatic mobilization, toracic mobilization and manipulation Receives: Other: Manual therapy group |
| Control group | Placebo comparator | Placebo mobilization and manipulation Receives: Other: Sham-manual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Functions Test- FEV1 (Forced expiratory volume in the first second)
The forced expiratory volume in 1 second (FEV1) is the volume of air (in liters) exhaled in the first second during forced exhalation after maximal inspiration.
Measured: Change from before and 5 minutes after application
Pulmonary Functions Test-FVC (Forced vital capacity)
Forced vital capacity, the maximum amount of air you can forcibly exhale from your lungs after fully inhaling.
Measured: Change from before and 5 minutes after application
Pulmonary Functions Test- FEV1/FVC
The FEV1/FVC ratio is the ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs.
Measured: Change from before and 5 minutes after application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start1 Jul 2023
- Primary completion30 Jul 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health Young IndividualsStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eylem KÜÇÜK, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05934240
- Sponsor's protocol ID
- HacettepeUEKC
- Status last verified
- Sep 2023
- First submitted
- 21 Jun 2023
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kucuk E, Tozcu D, Topaktas B, Coskun G. Immediate effects of manual therapy on respiratory functions in healthy young individuals: a randomized controlled trial. Sci Rep. 2024 Jul 29;14(1):17419. doi: 10.1038/s41598-024-68654-7.
PubMed 39075156
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immediate Effect of Manual Therapy Application on Respiratory Functions in Healthy
- ClinicalTrials.gov ID
- NCT05934240
- Acronym / sponsor ID
- HacettepeUEKC
- Conditions
- Health Young Individuals
- Keywords
- Manual therapy, Respiratory function test, Physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 6 Jul 2023 (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.
Manual therapy techniques targeting the thoracic region are commonly used in clinical practice. It has been suggested that manual therapy interventions directed at the spine can increase mobility of the spine and chest wall, which may have a positive impact on lung functions. The potential positive effects of thoracic manipulation on respiratory system diseases such as chronic obstructive pulmonary disease (COPD) and asthma have been investigated and continue to be studied. Specifically, the results of studies investigating the physiological outcomes of this therapeutic approach in healthy adults are conflicting. The aim of this study is to investigate the short-term effects of thoracic manipulation and mobilization, as well as diaphragm mobilization, through a single session of manual therapy interventions on respiratory functions.
Detailed description
In this planned study, designed as a randomized controlled intervention trial, two groups will be formed: an experimental group and a control group. After completing these procedures, the intervention group will receive the method of "thoracic mobilization and manipulation with diaphragm mobilization," while the control group will receive a placebo thoracic mobilization method. All techniques will be applied by a physiotherapist.
Within 5 minutes after the completion of the intervention, a respiratory function test will be repeated, resulting in a total of two respiratory function tests: one before the intervention and one after the intervention. The changes in respiratory function criteria before and after the intervention will be compared in both groups
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Active comparator | Other: Manual therapy groupDiaphragmatic mobilization, toracic mobilization and manipulation |
| Control group | Placebo comparator | Other: Sham-manual therapyPlacebo mobilization and manipulation |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- be between the ages of 18-25,
- to be a studen
Key exclusion criteria (3 listed)
- those who have any health problems
- those with orthopedic disorders
- those with systemic and cardiopulmonary diseases that would interfere with the evaluation
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 |
|---|---|---|
| Manual therapy groupManual therapy will be applied to the diaphragm and thoracic region. | Other | Experimental group |
| Sham-manual therapySham-manual therapy will be applied to the diaphragm and thoracic region. | Other | Control group |
Primary outcome
Pulmonary Functions Test- FEV1 (Forced expiratory volume in the first second)
Time frame: Change from before and 5 minutes after application
The forced expiratory volume in 1 second (FEV1) is the volume of air (in liters) exhaled in the first second during forced exhalation after maximal inspiration.
Pulmonary Functions Test-FVC (Forced vital capacity)
Time frame: Change from before and 5 minutes after application
Forced vital capacity, the maximum amount of air you can forcibly exhale from your lungs after fully inhaling.
Pulmonary Functions Test- FEV1/FVC
Time frame: Change from before and 5 minutes after application
The FEV1/FVC ratio is the ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs.
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 22 Sep 2023.
- Derived from this study: PubMed 39075156Kucuk E, Tozcu D, Topaktas B, Coskun G. Immediate effects of manual therapy on respiratory functions in healthy young individuals: a randomized controlled trial. Sci Rep. 2024 Jul 29;14(1):17419. doi: 10.1038/s41598-024-68654-7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual therapy group in people with Health Young Individuals, run by Hacettepe 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 2 inclusion and 3 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 22 Sep 2023. 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. Some participants in this study may receive a placebo. 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?
Pulmonary Functions Test- FEV1 (Forced expiratory volume in the first second) (time frame: Change from before and 5 minutes after application). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05934240, which also lists 1 linked publication.
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 22 Sep 2023.