Chronic Obstructive Pulmonary DiseaseNCT05723302
Chronic Obstructive Pulmonary Diseases and Proprioceptive Neuromuscular Facilitation
A study testing MIP/MEP in people with Chronic Obstructive Pulmonary Disease, run by Istanbul Medipol University Hospital at 2 sites in Turkey (Türkiye).
Trial summary
To investigate the effects of resistant proprioceptive neuromuscular facilitation exercises on physical fitness, respiratory muscle strength, walking distance and quality of life in chronic obstructive pulmonary patients. Read more about this study
- Who is it for?
- Ages 38 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- MIP/MEP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 20 Jan 2017to 1 Dec 2022
- 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 38 to 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be diagnosed with stage 1, stage 2 and stage 3 COPD according to GOLD (Global Initiative for Obstructive Lung Diseases) criteria
- Having FEV1/FVC <70% according to pulmonary function test
- Being clinically stable
- Being over 18 years old
- Volunteer to participate in the program
Who cannot join
- Having a COPD exacerbation in the last 8 weeks
- To have participated in a regular exercise training program in the last 1 year
- Having a musculoskeletal disease and neuromuscular disease that may prevent exercise
- Inability to cooperate for pulmonary function test and respiratory muscle strength measurement
- Being on long-term oxygen therapy
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Mehmet Akif Ersoy State Hospital
Çanakkale, 17100
Çanakkale Onsekiz Mart University
Çanakkale, 17100
About this study
Official title: The Effect of Resistant Proprioceptive Neuromuscular Facilitation Exercises on Respiratory Muscle Strength in Chronic Obstructive Pulmonary Diseases
To investigate the effects of resistant proprioceptive neuromuscular facilitation exercises on physical fitness, respiratory muscle strength, walking distance and quality of life in chronic obstructive pulmonary patients.
Read the detailed description
The study was carried out between January 2017 and January 2019, with patients followed up with the diagnosis of COPD in Çanakkale Mehmet Akif Ersoy State Hospital and Çanakkale Onsekiz Mart University Medical Faculty Hospital, Department of Chest Diseases. It was approved by Istanbul Medipol University Non-Interventional Clinical Research Ethics Committee (Date: 30.12.2016, Decision No. 573) and was done in accordance with the Declaration of Helsinki. All participants were informed about the purpose of the study, the total duration of treatment and the applications to be made, and a consent form was signed. The study was conducted as a prospective and randomized controlled study, and inclusion and exclusion criteria were determined.
Thirty-five patients diagnosed with COPD were referred to the study, four patients were excluded because they did not meet the inclusion criteria, and the study was conducted with a total of 31 participants.
The 31 patients included in the study were randomized after their initial evaluation and divided into two groups as experimental and control groups. Patients meeting the inclusion criteria were divided into 2 groups. Randomized by ordering by date of application.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- MIP/MEP
- Keywords
- COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIP/MEPDiagnostic test
MIP/MEP
| Study group | Role | What they receive |
|---|---|---|
| Maximal Inspiratory Pressure | Experimental | MIP Maximal Inspiratory Pressure Receives: Diagnostic Test: MIP/MEP |
| Maximal Expiratory Pressure | Experimental | MEP Maximal Expiratory Pressure Receives: Diagnostic Test: MIP/MEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
HADS
Hospital Anxiety Depression Scale
Measured: 10 minutes
Secondary outcomes (1)
SGRQ
St George's Respiratory Questionnaire
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start20 Jan 2017
- Primary completion17 Mar 2019
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mehmet Akif Ersoy Canakkale State Hospital, Çanakkale Onsekiz Mart University
- Responsible party
- Principal investigator, sevda vurur, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05723302
- Sponsor's protocol ID
- IstanbulMUH_1999
- Status last verified
- Feb 2023
- First submitted
- 3 Feb 2023
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- 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 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Resistant Proprioceptive Neuromuscular Facilitation Exercises on Respiratory Muscle Strength in Chronic Obstructive Pulmonary Diseases
- ClinicalTrials.gov ID
- NCT05723302
- Acronym / sponsor ID
- IstanbulMUH_1999
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Collaborators
- Mehmet Akif Ersoy Canakkale State Hospital, Çanakkale Onsekiz Mart University
- Study start
- 20 Jan 2017 (actual)
- Primary completion
- 17 Mar 2019 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 10 Feb 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.
To investigate the effects of resistant proprioceptive neuromuscular facilitation exercises on physical fitness, respiratory muscle strength, walking distance and quality of life in chronic obstructive pulmonary patients.
Detailed description
The study was carried out between January 2017 and January 2019, with patients followed up with the diagnosis of COPD in Çanakkale Mehmet Akif Ersoy State Hospital and Çanakkale Onsekiz Mart University Medical Faculty Hospital, Department of Chest Diseases. It was approved by Istanbul Medipol University Non-Interventional Clinical Research Ethics Committee (Date: 30.12.2016, Decision No. 573) and was done in accordance with the Declaration of Helsinki. All participants were informed about the purpose of the study, the total duration of treatment and the applications to be made, and a consent form was signed. The study was conducted as a prospective and randomized controlled study, and inclusion and exclusion criteria were determined.
Thirty-five patients diagnosed with COPD were referred to the study, four patients were excluded because they did not meet the inclusion criteria, and the study was conducted with a total of 31 participants.
The 31 patients included in the study were randomized after their initial evaluation and divided into two groups as experimental and control groups. Patients meeting the inclusion criteria were divided into 2 groups. Randomized by ordering by date of application.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maximal Inspiratory Pressure | Experimental | Diagnostic Test: MIP/MEPMIP Maximal Inspiratory Pressure |
| Maximal Expiratory Pressure | Experimental | Diagnostic Test: MIP/MEPMEP Maximal Expiratory Pressure |
Who may qualify
- Ages
- 38 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- To be diagnosed with stage 1, stage 2 and stage 3 COPD according to GOLD (Global Initiative for Obstructive Lung Diseases) criteria
- Having FEV1/FVC <70% according to pulmonary function test
- Being clinically stable
- Being over 18 years old
- Volunteer to participate in the program
Key exclusion criteria (5 listed)
- Having a COPD exacerbation in the last 8 weeks
- To have participated in a regular exercise training program in the last 1 year
- Having a musculoskeletal disease and neuromuscular disease that may prevent exercise
- Inability to cooperate for pulmonary function test and respiratory muscle strength measurement
- Being on long-term oxygen therapy
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 |
|---|---|---|
| MIP/MEPMIP/MEP | Diagnostic test | Maximal Expiratory Pressure, Maximal Inspiratory Pressure |
Primary outcome
HADS
Time frame: 10 minutes
Hospital Anxiety Depression Scale
1 secondary outcome
SGRQ
Time frame: 15 minutes
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 Feb 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIP/MEP in people with Chronic Obstructive Pulmonary Disease, run by Istanbul Medipol University Hospital at 2 sites 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 5 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 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
HADS (time frame: 10 minutes). 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 Feb 2023.