Cystic FibrosisNCT01266473
Study of Individualized Physiotherapy for Airway Clearance in Cystic Fibrosis.
A study testing Physiotherapy in people with Cystic Fibrosis, run by Oslo University Hospital.
Trial summary
The purpose of this study is to investigate individual efficacy in Physiotherapy for Airway Clearance, and to investigate user experience, i.e.utility value and preference. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to Apr 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis: CF
- Age >18 years
- Amount of sputum >5 ml/60 min
- Wet inhalation of saline/DNase/both
- Informed consent
Who cannot join
- Respiratory failure
- Hemoptysis
- Bacteriology (burkholderia cephacia, multi-resistent pseudomonas aeruginosa, atypical mycobacteria, MRSA).
- Ongoing intravenous medication
- Pregnancy
About this study
Official title: Efficacy Study of Physiotherapy for Airway Clearance in Cystic Fibrosis. Randomized Controlled Trials in Single Subjects (N of 1 RCT's).
The purpose of this study is to investigate individual efficacy in Physiotherapy for Airway Clearance, and to investigate user experience, i.e.utility value and preference.
- Conditions
- Cystic Fibrosis
- Being tested
- Physiotherapy
- Keywords
- Adults
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyOther
Physiotherapy for Airway Clearance
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy techniques | Experimental | Cough Technique vs Forced Expiration Technique Receives: Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expectorated sputum (gram)
Total amount of expectorated sputum (g) will be collected and weighed wet after each intervention for eight weeks, using a Mettler TOLEDO Weighing Balance (EL 202, accuracy: 0.01 g).
N of 1 trial design. Each trial consist of eight pairs (8 weeks) of treatment periods with two interventions each week (one with Cough Technique and one with Forced Expiration technique), 16 treatments for each participant. Outcome measure after each treatment.
Measured: 8 weeks
Secondary outcomes (1)
Patient's experience, i.e. perceived utility value and preference of technique.
Utility value: Measured by self-reported questionnaire after completion of each intervention in week 8.
Preference: Measured by three self-reported questions after both interventions in week 8.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2010 (estimated)
- Study startAug 2010
- Primary completionApr 2011
- Study completionApr 2011
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 Oslo University HospitalThe 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandra Gursli, PT, MSc, Principal investigator, Oslo University Hospital, National Centre for cystic fibrosis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01266473
- Sponsor's protocol ID
- 2010/802
- Status last verified
- Jan 2013
- First submitted
- 6 Sep 2010
- Last updated
- 11 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Gursli S, Quittner A, Jahnsen RB, Skrede B, Stuge B, Bakkeheim E. Airway clearance physiotherapy and health-related quality of life in cystic fibrosis. PLoS One. 2022 Oct 18;17(10):e0276310. doi: 10.1371/journal.pone.0276310. eCollection 2022.
PubMed 36256673
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Study of Physiotherapy for Airway Clearance in Cystic Fibrosis. Randomized Controlled Trials in Single Subjects (N of 1 RCT's).
- ClinicalTrials.gov ID
- NCT01266473
- Acronym / sponsor ID
- 2010/802
- Conditions
- Cystic Fibrosis
- Keywords
- Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 24 Dec 2010 (estimated)
- 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 purpose of this study is to investigate individual efficacy in Physiotherapy for Airway Clearance, and to investigate user experience, i.e.utility value and preference.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy techniques | Experimental | Other: PhysiotherapyCough Technique vs Forced Expiration Technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis: CF
- Age >18 years
- Amount of sputum >5 ml/60 min
- Wet inhalation of saline/DNase/both
- Informed consent
Key exclusion criteria (5 listed)
- Respiratory failure
- Hemoptysis
- Bacteriology (burkholderia cephacia, multi-resistent pseudomonas aeruginosa, atypical mycobacteria, MRSA).
- Ongoing intravenous medication
- Pregnancy
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 |
|---|---|---|
| PhysiotherapyPhysiotherapy for Airway Clearance | Other | Physiotherapy techniques |
Primary outcome
Expectorated sputum (gram)
Time frame: 8 weeks
Total amount of expectorated sputum (g) will be collected and weighed wet after each intervention for eight weeks, using a Mettler TOLEDO Weighing Balance (EL 202, accuracy: 0.01 g). N of 1 trial design. Each trial consist of eight pairs (8 weeks) of treatment periods with two interventions each week (one with Cough Technique and one with Forced Expiration technique), 16 treatments for each participant. Outcome measure after each treatment.
1 secondary outcome
Patient's experience, i.e. perceived utility value and preference of technique.
Time frame: 8 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 11 Jan 2013.
- Derived from this study: PubMed 36256673Gursli S, Quittner A, Jahnsen RB, Skrede B, Stuge B, Bakkeheim E. Airway clearance physiotherapy and health-related quality of life in cystic fibrosis. PLoS One. 2022 Oct 18;17(10):e0276310. doi: 10.1371/journal.pone.0276310. eCollection 2022.
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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.
Sandra Gursli, PT, MSc principal investigator
Oslo University Hospital, National Centre for cystic fibrosis
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy in people with Cystic Fibrosis, run by Oslo University Hospital.
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 11 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Expectorated sputum (gram) (time frame: 8 weeks). 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 NCT01266473, 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 11 Jan 2013.