Chronic Obstructive Pulmonary Disease SevereNCT04533516
Additional Manual Therapy Over Inspiratory Muscle Training in COPD
A study testing Manual therapy technics and Inspiratory Muscle Training in people with Chronic Obstructive Pulmonary Disease Severe and Muscle Weakness, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
The benefits of inspiratory muscle training(IMT) in patients with chronic obstructive pulmonary disease(COPD) were reported.But in severe COPD patients, benefit from IMT may be limited.There is need for further research in new and complementary modalities to improve IMT efficiency in severe COPD patients.Manual… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease Severe, Muscle Weakness
- What is being tested?
- Manual therapy technics and Inspiratory Muscle Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Aug 2020to 12 Apr 2021
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of chronic obstructive pulmonary disease
- Being clinically stable
- Having FEV1/FVC ratio of ≤ 50% of the predicted value after bronchodilator drugs.
Who cannot join
- Having an acute bronchitis,
- Having a pneumonia,
- Having an exacerbation of COPD,
- Having thoracic spinal scoliosis,
- Having substantial chest wall deformity, or acute rib or vertebral fracture.
- Unable to perform the pulmonary function test because of cognitive or physical impairments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of 12-Weeks Inspiratory Muscle Training With Manual Therapy in Patients With COPD: Randomized Controlled Study
The benefits of inspiratory muscle training(IMT) in patients with chronic obstructive pulmonary disease(COPD) were reported.But in severe COPD patients, benefit from IMT may be limited.There is need for further research in new and complementary modalities to improve IMT efficiency in severe COPD patients.Manual therapy(MT) additional over IMT may be such a new approach that has not yet been investigated in COPD.
Aims: To investigate effects of MT additional over IMT on functional capacity,respiratory muscle strength,pulmonary function,dyspnea, fatigue and quality of life in severe COPD patients.
Methods: It was a prospective single-blind randomized trial. 40 patients with COPD in Global Initiative for Chronic Obstructive Lung Disease(GOLD) stage III-IV were included. Patients were randomly assigned to receive either MT additional over IMT at 40% of maximal inspiratory pressure(MIP)(n= 20) or only IMT(n= 20) for 12 weeks. MT group received MT during 12 weeks for 40 minutes additional to IMT. Pulmonary function using spirometry, respiratory muscle strength using mouth pressure device, functional capacity using six minute walk test, dyspnea using Modified Medical Research Council(MMRC) dyspnea scale, fatigue using fatigue severity scale and quality of life using St. George's Respiratory Questionnaire(SGRQ) were evaluated.
- Being tested
- Manual therapy technics, Inspiratory Muscle Training
- Keywords
- copd, manual therapy, inspiratory muscle therapy
- Medical subject headings
- Muscle Weakness, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual therapy technicsOther
Manual therapy technics
Inspiratory Muscle TrainingOther
Inspiratory Muscle Training
| Study group | Role | What they receive |
|---|---|---|
| Manual Therapy additional over Inspiratory muscle training | Experimental | Participants receive manual therapy protocol session three times a week for 12 weeks. The manual therapy protocol session lasts 30 minutes and included of the following manual therapy techniques: suboccipital decompression, gliding of the cervical vertebral articulations in the anterior/posterior direction, myofascial release of sternocleidomastoid and trapezius muscles, gliding of sternoclavicular joint in the anterior/posterior direction, myofascial release of intercostal muscles and paravertebral muscles, diaphragmatic release, rib raising, mobilization of scapulothoracic joint, and gliding of the thoracic vertebral articulations in the anterior/posterior direction. And all participants receive inspiratory muscle training. Receives: Other: Manual therapy technics; Other: Inspiratory Muscle Training |
| Inspiratory Muscle Training | Active comparator | Participants receive only inspiratory muscle training by using Threshold Inspiratory Muscle Training device. Training load is 40% of the measured maximum inspiratory pressure, weekly. Participants receive inspiratory muscle training session for 30 min-per day, 7 days per week, for 12 weeks. Receives: Other: Inspiratory Muscle Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Function Test
Before the pulmonary function test, all subjects rested to avoid fatigue. The lung function test including forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), and vital capacity (VC) was performed in a seated position using a portable spirometer according to the American Thoracic Society guidelines.
Measured: 12 weeks
respiratory muscle strength
For respiratory muscle strength, maximal inspiratory pressure (MIP), and maximal expiratory pressure (MEP) were evaluated using an electronic pressure transducer. MIP was measured at residual volume, and MEP was measured from total lung capacity.
Measured: 12 weeks
6 minute walk test
6 minute walk test (6MWT) was applied to measure exercise capacity. The patient's heart rate, breathing frequency, and oxygen saturation were monitored with the pulse oximeter, and the values were recorded before and after the test. The distance was expressed both as metres.
Measured: 12 weeks
Dyspnea perception
Dyspnea perception was assessed using the modified Medical Research Council (MMRC) dyspnea scale, Levels of dyspnea are graded 0 (absence of dyspnea during strenuous exercise), to 4 (dyspnea during daily activities).
Measured: 12 weeks
Fatigue perception
Fatigue perception was assessed with Turkish version of Fatigue Severity Scale. A high score indicates increased fatigue intensity and the maximum score of the scale is 63.
Measured: 12 weeks
St.George Respiratory Questionnaire
Quality of life was measured using the Turkish version of St.George Respiratory Questionnaire (SGRQ). It is a specific quality of life questionnaire for respiratory diseases. SGRQ consists of three subscale and 50 items; symptoms (8 items), activities (16 items), effects of the disease (26 items). Each subscale is scored ranging from 0 to 100 points. High scores indicate that worsened the quality of life.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start29 Aug 2020
- Primary completion5 Jan 2021
- Study completion12 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease SevereStudies of the same condition, open and under way.
- More trials run by Istinye 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Çırak, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04533516
- Sponsor's protocol ID
- Manual therapy in COPD
- Status last verified
- Jul 2021
- First submitted
- 25 Aug 2020
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of 12-Weeks Inspiratory Muscle Training With Manual Therapy in Patients With COPD: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04533516
- Acronym / sponsor ID
- Manual therapy in COPD
- Keywords
- copd, manual therapy, inspiratory muscle therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 29 Aug 2020 (actual)
- Primary completion
- 5 Jan 2021 (actual)
- Study completion
- 12 Apr 2021 (actual)
- First posted
- 31 Aug 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.
The benefits of inspiratory muscle training(IMT) in patients with chronic obstructive pulmonary disease(COPD) were reported.But in severe COPD patients, benefit from IMT may be limited.There is need for further research in new and complementary modalities to improve IMT efficiency in severe COPD patients.Manual therapy(MT) additional over IMT may be such a new approach that has not yet been investigated in COPD.
Aims: To investigate effects of MT additional over IMT on functional capacity,respiratory muscle strength,pulmonary function,dyspnea, fatigue and quality of life in severe COPD patients.
Methods: It was a prospective single-blind randomized trial. 40 patients with COPD in Global Initiative for Chronic Obstructive Lung Disease(GOLD) stage III-IV were included. Patients were randomly assigned to receive either MT additional over IMT at 40% of maximal inspiratory pressure(MIP)(n= 20) or only IMT(n= 20) for 12 weeks. MT group received MT during 12 weeks for 40 minutes additional to IMT. Pulmonary function using spirometry, respiratory muscle strength using mouth pressure device, functional capacity using six minute walk test, dyspnea using Modified Medical Research Council(MMRC) dyspnea scale, fatigue using fatigue severity scale and quality of life using St. George's Respiratory Questionnaire(SGRQ) were evaluated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual Therapy additional over Inspiratory muscle training | Experimental | Other: Manual therapy technics, Other: Inspiratory Muscle TrainingParticipants receive manual therapy protocol session three times a week for 12 weeks. The manual therapy protocol session lasts 30 minutes and included of the following manual therapy techniques: suboccipital decompression, gliding of the cervical vertebral articulations in the anterior/posterior direction, myofascial release of sternocleidomastoid and trapezius muscles, gliding of sternoclavicular joint in the anterior/posterior direction, myofascial release of intercostal muscles and paravertebral muscles, diaphragmatic release, rib raising, mobilization of scapulothoracic joint, and gliding of the thoracic vertebral articulations in the anterior/posterior direction. And all participants receive inspiratory muscle training. |
| Inspiratory Muscle Training | Active comparator | Other: Inspiratory Muscle TrainingParticipants receive only inspiratory muscle training by using Threshold Inspiratory Muscle Training device. Training load is 40% of the measured maximum inspiratory pressure, weekly. Participants receive inspiratory muscle training session for 30 min-per day, 7 days per week, for 12 weeks. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of chronic obstructive pulmonary disease
- Being clinically stable
- Having FEV1/FVC ratio of ≤ 50% of the predicted value after bronchodilator drugs.
Key exclusion criteria (6 listed)
- Having an acute bronchitis,
- Having a pneumonia,
- Having an exacerbation of COPD,
- Having thoracic spinal scoliosis,
- Having substantial chest wall deformity, or acute rib or vertebral fracture.
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 technicsManual therapy technics | Other | Manual Therapy additional over Inspiratory muscle training |
| Inspiratory Muscle TrainingInspiratory Muscle Training | Other | Inspiratory Muscle Training, Manual Therapy additional over Inspiratory muscle training |
Primary outcome
Pulmonary Function Test
Time frame: 12 weeks
Before the pulmonary function test, all subjects rested to avoid fatigue. The lung function test including forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), and vital capacity (VC) was performed in a seated position using a portable spirometer according to the American Thoracic Society guidelines.
respiratory muscle strength
Time frame: 12 weeks
For respiratory muscle strength, maximal inspiratory pressure (MIP), and maximal expiratory pressure (MEP) were evaluated using an electronic pressure transducer. MIP was measured at residual volume, and MEP was measured from total lung capacity.
6 minute walk test
Time frame: 12 weeks
6 minute walk test (6MWT) was applied to measure exercise capacity. The patient's heart rate, breathing frequency, and oxygen saturation were monitored with the pulse oximeter, and the values were recorded before and after the test. The distance was expressed both as metres.
Dyspnea perception
Time frame: 12 weeks
Dyspnea perception was assessed using the modified Medical Research Council (MMRC) dyspnea scale, Levels of dyspnea are graded 0 (absence of dyspnea during strenuous exercise), to 4 (dyspnea during daily activities).
Fatigue perception
Time frame: 12 weeks
Fatigue perception was assessed with Turkish version of Fatigue Severity Scale. A high score indicates increased fatigue intensity and the maximum score of the scale is 63.
St.George Respiratory Questionnaire
Time frame: 12 weeks
Quality of life was measured using the Turkish version of St.George Respiratory Questionnaire (SGRQ). It is a specific quality of life questionnaire for respiratory diseases. SGRQ consists of three subscale and 50 items; symptoms (8 items), activities (16 items), effects of the disease (26 items). Each subscale is scored ranging from 0 to 100 points. High scores indicate that worsened the quality of life.
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 8 Jul 2021.
- Individual participant dataSharing planned: Undecided
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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 technics and Inspiratory Muscle Training in people with Chronic Obstructive Pulmonary Disease Severe and Muscle Weakness, run by Istinye 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 3 inclusion and 6 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 8 Jul 2021. 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?
Pulmonary Function Test (time frame: 12 weeks). The study lists 6 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 8 Jul 2021.