COPD Postural Control IMTNCT03790410
The Effect of Inspiratory Muscle Training on Postural Control in Chronic Obstructive Pulmonary Disease
A study testing Complex pulmonary rehabilitation and Inspiratory muscle training in people with COPD Postural Control IMT, run by Szeged University at 1 site in Hungary.
Trial summary
Deficits in postural control are increasingly recognized among the important secondary impairments in patients with chronic obstructive pulmonary disease (COPD). There are conflicting results regarding the effect of inspiratory muscle training in improvement of inspiratory muscle strength, endurance, and dyspnea in… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COPD Postural Control IMT
- What is being tested?
- Complex pulmonary rehabilitation and Inspiratory muscle training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteHungary
- Study dates
- 1 Jul 2017to 28 Feb 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Stable COPD
- Do not take part in other treatment
- Be able to learn the usage of inspiratory muscle trainer
Who cannot join
- Acute exacerbation
- Balance problems with neurological cause
- The patient unable to cooperate
- Participation in pulmonary rehabilitation 3 months before the study
- IMT use in the 3 months before the study
Trial locations and contacts
1 site in 1 country.
About this study
Deficits in postural control are increasingly recognized among the important secondary impairments in patients with chronic obstructive pulmonary disease (COPD). There are conflicting results regarding the effect of inspiratory muscle training in improvement of inspiratory muscle strength, endurance, and dyspnea in stable COPD patients. The main inspiratory muscle, the diaphragm has also a stabilizing function of the trunk. The aim of this study to enhance postural control of COPD patients with improving the stability of the trunk by using inspiratory muscle training.
Read the detailed description
The study is a randomized controlled trial in patients with stable COPD. The participants are divided into two groups. Patients in the inspiratory muscle training (IMT) group take part in a complex pulmonary rehabilitation program containing breathing exercises, bicycle ergometer conditionings, relaxations, strength and endurance trainings completed by inspiratory muscle training. The members of the IMT group use the POWERbreathe Medic device. The control group perform the complex pulmonary rehabilitation program without IMT. The program is divided into 3 weeks inpatient period and 3 weeks home period. Before, between and after the 3 weeks period all subjects are measured. 60 patients are planned to take part in the investigation. The inspiratory muscle strength is measured by POWERbreathe K1 device. Balance is assessed by functional balance tests: Timed Up and Go Test, Four Square Step Test, Modified Functional Reach Test, Modified Lateral Reach Test, Stand Up Test. Body Sway is measured by HR Mat VersaTek System. The diameter of the diaphragm muscle is assessed by B-mode ultrasound examination using Zonare Z. One Ultrasound System. Arterial stiffness parameters measured by Arteriograph.
- Conditions
- COPD Postural Control IMT
- Being tested
- Complex pulmonary rehabilitation, Inspiratory muscle training
- Keywords
- COPD Postural Control IMT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complex pulmonary rehabilitationOther
Complex pulmonary rehabilitation program containing breathing exercises, bicycle ergometer conditionings, relaxations, strength and endurance trainings.
Inspiratory muscle trainingOther
The training program contains strengthening exercises on the diaphragm muscle.
| Study group | Role | What they receive |
|---|---|---|
| Control group-Complex pulmonary rehab. | Active comparator | Complex pulmonary rehabilitation:
The complex pulmonary rehabilitation program containing breathing exercises, bicycle ergometer conditionings, relaxations, strength and endurance trainings. Receives: Other: Complex pulmonary rehabilitation |
| Inspiratory muscle training group | Active comparator | Complex pulmonary rehabilitation:
The complex pulmonary rehabilitation program containing breathing exercises, bicycle ergometer conditionings, relaxations, strength and endurance trainings.
Inspiratory muscle training
The training program contains strengthening exercises on the diaphragm muscle. Receives: Other: Complex pulmonary rehabilitation; Other: Inspiratory muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Inspiratory Pressure
The inspiratory pressure generated against a completely occluded airway; used to evaluate inspiratory respiratory muscle strength and readiness for weaning from A maximum inspiratory pressure is measured in H2Ocm. MIP is measured with POWERbreathe K1
Measured: 6 weeks
Timed Up and Go Test
Timed Up and Go: It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
Measured: 6 weeks
Four Square Step Test
Four Square Step Test:
The subject is required to sequentially step over four canes set-up in a cross configuration on the ground. The aim is to step as fast as possible into each square with both feet.
Measured: 6 weeks
Modified Functional Reach Test
Modified Functional Reach Test:
The MFRT assesses a patient's stability by measuring the maximum distance an individual can reach forward while sitting in a fixed position.
Measured: 6 weeks
Modified Lateral Reach Test
Modified Lateral Reach Test:
The MLRT assesses a patient's stability by measuring the maximum distance an individual can reach side direction while sitting in a fixed position.
Measured: 6 weeks
Stand Up Test
Stand Up Test:
Individual stand up from tailor sit from the floor as fast as possible.
Measured: 6 weeks
Secondary outcomes (9)
Sway analysis: COF area (cm2)
Sway is the oscillating movement of the body, while posture is the relative alignment and orientation of the segments of the body. Sway analysis is a systematic assessment of the readiness and stability of the human body to achieve and maintain equilibrium. Area and direction of sway, elliptical pattern of sway, distance and direction traveled by Center of Force (CoF) is measured with HR Mat VersaTek System.
Measured: 6 weeks
Sway analysis: COF distance (cm)
Sway is the oscillating movement of the body, while posture is the relative alignment and orientation of the segments of the body. Sway analysis is a systematic assessment of the readiness and stability of the human body to achieve and maintain equilibrium. Area and direction of sway, elliptical pattern of sway, distance and direction traveled by Center of Force (CoF) is measured with HR Mat VersaTek System.
Measured: 6 weeks
Sway analysis: COF variability (cm)
Sway is the oscillating movement of the body, while posture is the relative alignment and orientation of the segments of the body. Sway analysis is a systematic assessment of the readiness and stability of the human body to achieve and maintain equilibrium. Area and direction of sway, elliptical pattern of sway, distance and direction traveled by Center of Force (CoF) is measured with HR Mat VersaTek System.
Measured: 6 weeks
Sway analysis: COF A-P excursion (cm)
Sway is the oscillating movement of the body, while posture is the relative alignment and orientation of the segments of the body. Sway analysis is a systematic assessment of the readiness and stability of the human body to achieve and maintain equilibrium. Area and direction of sway, elliptical pattern of sway, distance and direction traveled by Center of Force (CoF) is measured with HR Mat VersaTek System.
Measured: 6 weeks
Sway analysis: COF L-R excursion (cm)
Sway is the oscillating movement of the body, while posture is the relative alignment and orientation of the segments of the body. Sway analysis is a systematic assessment of the readiness and stability of the human body to achieve and maintain equilibrium. Area and direction of sway, elliptical pattern of sway, distance and direction traveled by Center of Force (CoF) is measured with HR Mat VersaTek System.
Measured: 6 weeks
Thickness of the diaphragm muscle's belly
The diameter of the diaphragm muscle is assessed by B-mode ultrasound examination using Zonare Z. One Ultrasound System.
Measured: 6 weeks
Vibration Sense Testing
Tuning fork is used to evaluate the deep sensation.
Measured: 6 weeks
Pulse wave velocity
Pulse wave velocity is measured with Arteriograph.
Measured: 6 weeks
Augmentation index
Augmentation index is measured with Arteriograph
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2018
- Study start1 Jul 2017
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD Postural Control IMTStudies 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
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Szeged University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Levente Szilagyi, Szeged University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03790410
- Sponsor's protocol ID
- COPD IMT PC
- Status last verified
- Oct 2020
- First submitted
- 20 Dec 2018
- Last updated
- 2 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Inspiratory Muscle Training on Postural Control in Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT03790410
- Acronym / sponsor ID
- COPD IMT PC
- Conditions
- COPD Postural Control IMT
- Keywords
- COPD Postural Control IMT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Szeged UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 31 Dec 2018 (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.
Deficits in postural control are increasingly recognized among the important secondary impairments in patients with chronic obstructive pulmonary disease (COPD). There are conflicting results regarding the effect of inspiratory muscle training in improvement of inspiratory muscle strength, endurance, and dyspnea in stable COPD patients. The main inspiratory muscle, the diaphragm has also a stabilizing function of the trunk. The aim of this study to enhance postural control of COPD patients with improving the stability of the trunk by using inspiratory muscle training.
Detailed description
The study is a randomized controlled trial in patients with stable COPD. The participants are divided into two groups. Patients in the inspiratory muscle training (IMT) group take part in a complex pulmonary rehabilitation program containing breathing exercises, bicycle ergometer conditionings, relaxations, strength and endurance trainings completed by inspiratory muscle training. The members of the IMT group use the POWERbreathe Medic device. The control group perform the complex pulmonary rehabilitation program without IMT. The program is divided into 3 weeks inpatient period and 3 weeks home period. Before, between and after the 3 weeks period all subjects are measured. 60 patients are planned to take part in the investigation. The inspiratory muscle strength is measured by POWERbreathe K1 device. Balance is assessed by functional balance tests: Timed Up and Go Test, Four Square Step Test, Modified Functional Reach Test, Modified Lateral Reach Test, Stand Up Test. Body Sway is measured by HR Mat VersaTek System. The diameter of the diaphragm muscle is assessed by B-mode ultrasound examination using Zonare Z. One Ultrasound System. Arterial stiffness parameters measured by Arteriograph.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group-Complex pulmonary rehab. | Active comparator | Other: Complex pulmonary rehabilitationComplex pulmonary rehabilitation: The complex pulmonary rehabilitation program containing breathing exercises, bicycle ergometer conditionings, relaxations, strength and endurance trainings. |
| Inspiratory muscle training group | Active comparator | Other: Complex pulmonary rehabilitation, Other: Inspiratory muscle trainingComplex pulmonary rehabilitation: The complex pulmonary rehabilitation program containing breathing exercises, bicycle ergometer conditionings, relaxations, strength and endurance trainings. Inspiratory muscle training The training program contains strengthening exercises on the diaphragm muscle. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Stable COPD
- Do not take part in other treatment
- Be able to learn the usage of inspiratory muscle trainer
Key exclusion criteria (5 listed)
- Acute exacerbation
- Balance problems with neurological cause
- The patient unable to cooperate
- Participation in pulmonary rehabilitation 3 months before the study
- IMT use in the 3 months before the study
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 |
|---|---|---|
| Complex pulmonary rehabilitationComplex pulmonary rehabilitation program containing breathing exercises, bicycle ergometer conditionings, relaxations, strength and endurance trainings. | Other | Control group-Complex pulmonary rehab., Inspiratory muscle training group |
| Inspiratory muscle trainingThe training program contains strengthening exercises on the diaphragm muscle. | Other | Inspiratory muscle training group |
Primary outcome
Maximal Inspiratory Pressure
Time frame: 6 weeks
The inspiratory pressure generated against a completely occluded airway; used to evaluate inspiratory respiratory muscle strength and readiness for weaning from A maximum inspiratory pressure is measured in H2Ocm. MIP is measured with POWERbreathe K1
Timed Up and Go Test
Time frame: 6 weeks
Timed Up and Go: It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
Four Square Step Test
Time frame: 6 weeks
Four Square Step Test: The subject is required to sequentially step over four canes set-up in a cross configuration on the ground. The aim is to step as fast as possible into each square with both feet.
Modified Functional Reach Test
Time frame: 6 weeks
Modified Functional Reach Test: The MFRT assesses a patient's stability by measuring the maximum distance an individual can reach forward while sitting in a fixed position.
Modified Lateral Reach Test
Time frame: 6 weeks
Modified Lateral Reach Test: The MLRT assesses a patient's stability by measuring the maximum distance an individual can reach side direction while sitting in a fixed position.
Stand Up Test
Time frame: 6 weeks
Stand Up Test: Individual stand up from tailor sit from the floor as fast as possible.
9 secondary outcomes
Sway analysis: COF area (cm2)
Time frame: 6 weeks
Sway analysis: COF distance (cm)
Time frame: 6 weeks
Sway analysis: COF variability (cm)
Time frame: 6 weeks
Sway analysis: COF A-P excursion (cm)
Time frame: 6 weeks
Sway analysis: COF L-R excursion (cm)
Time frame: 6 weeks
Thickness of the diaphragm muscle's belly
Time frame: 6 weeks
Vibration Sense Testing
Time frame: 6 weeks
Pulse wave velocity
Time frame: 6 weeks
Augmentation index
Time frame: 6 weeks
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 2 Nov 2020.
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 Complex pulmonary rehabilitation and Inspiratory muscle training in people with COPD Postural Control IMT, run by Szeged University at 1 site in Hungary.
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 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 2 Nov 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 Hungary. 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?
Maximal Inspiratory Pressure (time frame: 6 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 2 Nov 2020.