Cystic FibrosisNCT03375684
Effects of Inspiratory Muscle Training on Postural Stability, Balance, Pulmonary Function and Functional Capacity in Children With Cystic Fibrosis
A study testing Conventional chest physiotherapy and Inspiratory muscle training in people with Cystic Fibrosis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
It is extensively reported in the literature that patients with chronic obstructive lung disease may have impairments in balance and postural control which further increase the disease burden. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Conventional chest physiotherapy and Inspiratory muscle training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2018to 21 May 2018
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Cystic fibrosis diagnosis
- Stable clinical condition (no exacerbation in last 4 weeks)
Who cannot join
- Documented diagnosis of vestibular, neurological or orthopedic disorders which may affect balance and mobility
- Subjects previously involved in exercise training or physiotherapy programs
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakif Universitesi, Department of Physiotherapy and Rehabilitation
Istanbul, Eyup, 34060
About this study
It is extensively reported in the literature that patients with chronic obstructive lung disease may have impairments in balance and postural control which further increase the disease burden. Mechanisms related to these impairments include, but are not limited to increased work of breathing, diaphragm weakness, peripheral muscle weakness and systemic inflammation. Since the similar symptoms are reported for the children with cystic fibrosis, it is hypothesized that balance and postural control may also be compromised in these patients. Inspiratory muscle training (IMT) is shown to improve diaphragm strength and pulmonary function. Considering the relation between diaphragm which is one of the core muscles, and balance, IMT may also have an impact on postural control and balance alongside the standard clinical parameters such as respiratory muscle strength, pulmonary function and functional capacity in these patients. Thus, the aim of this study was to investigate the effects of inspiratory muscle training and conventional chest physiotherapy on postural stability, balance, pulmonary function and functional capacity in children with cystic fibrosis.
- Conditions
- Cystic Fibrosis
- Being tested
- Conventional chest physiotherapy, Inspiratory muscle training
- Keywords
- Cystic Fibrosis, Inspiratory Muscle Training, Chest Physiotherapy, Balance, Postural Stability, Pulmonary Function Test, 6-Minute Walk Test
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional chest physiotherapyOther
Programme will include diaphragmatic breathing exercise, thoracic expansion exercises, incentive spirometer exercise (Triflo), oscillatory PEP (Flutter), postural drainage and coughing tecniques.
Inspiratory muscle trainingOther
Threshold IMT device will be used for the training. Training intensity will set at 30% of the maximum inspiratory pressure.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Patients in this group will receive conventional chest physiotherapy, two times a day, 7 days a week for 8 weeks. One exercise session will be supervised in a clinic per week, other sessions will be performed at home. Receives: Other: Conventional chest physiotherapy |
| Training Group | Experimental | In addition to conventional chest physiotherapy programme, patients in this group will also receive inspiratory muscle training for 15 minutes, twice a day, 7 days a week for 8 weeks. One exercise session will be supervised in a clinic per week, other sessions will be performed at home. Receives: Other: Conventional chest physiotherapy; Other: Inspiratory muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline postural stability test score in Biodex Balance System SD at 8 weeks
Measured: Eight weeks
Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks
Measured: Eight weeks
Change from baseline sensory integriation and balance test score in Biodex Balance System SD at 8 weeks
Measured: Eight weeks
Change from baseline Forced Vital Capacity (FVC) at 8 weeks
Measured: Eight weeks
Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks
Measured: Eight weeks
Change from baseline Peak Expiratory Flow (PEF) at 8 weeks
Measured: Eight weeks
Change from baseline maximum inspiratory pressure at 8 weeks
Measured: Eight weeks
Change from baseline maximum expiratory pressure at 8 weeks
Measured: Eight weeks
Change from baseline distance covered in six-minute walk test at 8 weeks
Measured: Eight weeks
Secondary outcomes (1)
Change from baseline m. quadriceps strength at 8 weeks
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start2 Jan 2018
- Primary completion2 May 2018
- Study completion21 May 2018
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 Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melih Zeren, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03375684
- Sponsor's protocol ID
- bvumzeren01
- Status last verified
- May 2018
- First submitted
- 6 Dec 2017
- Last updated
- 23 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zeren M, Cakir E, Gurses HN. Effects of inspiratory muscle training on postural stability, pulmonary function and functional capacity in children with cystic fibrosis: A randomised controlled trial. Respir Med. 2019 Mar;148:24-30. doi: 10.1016/j.rmed.2019.01.013. Epub 2019 Jan 28.
PubMed 30827470
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inspiratory Muscle Training on Postural Stability, Balance, Pulmonary Function and Functional Capacity in Children With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT03375684
- Acronym / sponsor ID
- bvumzeren01
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, Inspiratory Muscle Training, Chest Physiotherapy, Balance, Postural Stability, Pulmonary Function Test, 6-Minute Walk Test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 2 May 2018 (actual)
- Study completion
- 21 May 2018 (actual)
- First posted
- 18 Dec 2017 (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.
It is extensively reported in the literature that patients with chronic obstructive lung disease may have impairments in balance and postural control which further increase the disease burden. Mechanisms related to these impairments include, but are not limited to increased work of breathing, diaphragm weakness, peripheral muscle weakness and systemic inflammation. Since the similar symptoms are reported for the children with cystic fibrosis, it is hypothesized that balance and postural control may also be compromised in these patients. Inspiratory muscle training (IMT) is shown to improve diaphragm strength and pulmonary function. Considering the relation between diaphragm which is one of the core muscles, and balance, IMT may also have an impact on postural control and balance alongside the standard clinical parameters such as respiratory muscle strength, pulmonary function and functional capacity in these patients. Thus, the aim of this study was to investigate the effects of inspiratory muscle training and conventional chest physiotherapy on postural stability, balance, pulmonary function and functional capacity in children with cystic fibrosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Conventional chest physiotherapyPatients in this group will receive conventional chest physiotherapy, two times a day, 7 days a week for 8 weeks. One exercise session will be supervised in a clinic per week, other sessions will be performed at home. |
| Training Group | Experimental | Other: Conventional chest physiotherapy, Other: Inspiratory muscle trainingIn addition to conventional chest physiotherapy programme, patients in this group will also receive inspiratory muscle training for 15 minutes, twice a day, 7 days a week for 8 weeks. One exercise session will be supervised in a clinic per week, other sessions will be performed at home. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Cystic fibrosis diagnosis
- Stable clinical condition (no exacerbation in last 4 weeks)
Key exclusion criteria (2 listed)
- Documented diagnosis of vestibular, neurological or orthopedic disorders which may affect balance and mobility
- Subjects previously involved in exercise training or physiotherapy programs
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 |
|---|---|---|
| Conventional chest physiotherapyProgramme will include diaphragmatic breathing exercise, thoracic expansion exercises, incentive spirometer exercise (Triflo), oscillatory PEP (Flutter), postural drainage and coughing tecniques. | Other | Control Group, Training Group |
| Inspiratory muscle trainingThreshold IMT device will be used for the training. Training intensity will set at 30% of the maximum inspiratory pressure. | Other | Training Group |
Primary outcome
Change from baseline postural stability test score in Biodex Balance System SD at 8 weeks
Time frame: Eight weeks
Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks
Time frame: Eight weeks
Change from baseline sensory integriation and balance test score in Biodex Balance System SD at 8 weeks
Time frame: Eight weeks
Change from baseline Forced Vital Capacity (FVC) at 8 weeks
Time frame: Eight weeks
Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks
Time frame: Eight weeks
Change from baseline Peak Expiratory Flow (PEF) at 8 weeks
Time frame: Eight weeks
Change from baseline maximum inspiratory pressure at 8 weeks
Time frame: Eight weeks
Change from baseline maximum expiratory pressure at 8 weeks
Time frame: Eight weeks
Change from baseline distance covered in six-minute walk test at 8 weeks
Time frame: Eight weeks
1 secondary outcome
Change from baseline m. quadriceps strength at 8 weeks
Time frame: Eight 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 23 May 2018.
- Derived from this study: PubMed 30827470Zeren M, Cakir E, Gurses HN. Effects of inspiratory muscle training on postural stability, pulmonary function and functional capacity in children with cystic fibrosis: A randomised controlled trial. Respir Med. 2019 Mar;148:24-30. doi: 10.1016/j.rmed.2019.01.013. Epub 2019 Jan 28.
- 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 Conventional chest physiotherapy and Inspiratory muscle training in people with Cystic Fibrosis, run by Bezmialem Vakif 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 2 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 23 May 2018. 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 postural stability test score in Biodex Balance System SD at 8 weeks (time frame: Eight weeks). The study lists 9 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 NCT03375684, 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 23 May 2018.