BreathingNCT05330780
Breathing Room Intervention to Achieve Better Lung Health in Older Adults
A study testing Breathing Room in people with Breathing and Aging, run by University of Wisconsin, Milwaukee at 1 site in United States.
Trial summary
This proposed study will evaluate whether a novel nonpharmacological intervention, Breathing Room, can improve lung function in the target population of older adults. Therefore, the primary aim of this pilot is to examine the effect of Breathing Room on inspiratory muscle strength, spirometry confirmed ventilatory… Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- What is being tested?
- Breathing Room
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2022to 29 Nov 2023
- 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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- able to understand English
- baseline oxygen saturation level is above 85%
- spirometry-confirmed restrictive ventilatory pattern (forced vital capacity < 80% predicted, forced expiratory volume in 1 second/forced vital capacity ≥ 0.70
Who cannot join
- have lung disease classified as restrictive or obstructive
- have unstable angina/myocardial infarction, eye or lung surgery within the previous 8 weeks or aneurysm
- have had major orthopedic surgery in the last 12 weeks
- have been told they have heart failure, take a diuretic "water pill" and have been told to restrict their salt and fluid intake (symptoms that coincide with Stage C of heart failure based on the American College of Cardiology and the American Heart Association classification system
- score in the severely impaired range on the Short Orientation Memory Concentration Test
- history of spontaneous pneumothorax
Trial locations and contacts
1 site in 1 country.
United States1 site
Ovation Communities (Jewish Home/Chai Point)
Milwaukee, Wisconsin, 53202
About this study
This proposed study will evaluate whether a novel nonpharmacological intervention, Breathing Room, can improve lung function in the target population of older adults. Therefore, the primary aim of this pilot is to examine the effect of Breathing Room on inspiratory muscle strength, spirometry confirmed ventilatory function (Forced Expiratory Volume in one second (FEV1), Forced Vital Capacity (FVC) and FEV1/FVC), functional status, posture, physical activity, and lower respiratory infection rates.
Read the detailed description
Restrictive ventilatory patterns (RVPs) contribute to two prevalent problems in older adults: 1) the development of pneumonia and other lower respiratory infections; and 2) declining endurance for physical activity. The Breathing Room was developed as an exercise activity designed to open the thoracic cage, increase strength of the muscles of respiration with inspiratory muscle trainers, and optimize the breathing technique.
This will be a pretest-posttest design in which the outcomes are measured at baseline, and at two weeks and four weeks post start of Breathing Room intervention. Breathing Room classes will be held 3 times a week for 4 weeks (2 group classes, 1 individual reinforcement of Inspiratory Muscle Training [IMT] homework). The IMT homework includes 3 days 5 cycles of 5 breaths, each cycle followed by 2-minute rest. The IMT will be also utilized during the 2 group classes.
The group classes will be conducted with a maximum of 5 participants in each group. Data on inspiratory muscle strength, spirometry confirmed ventilatory function (Forced Expiratory Volume in one second (FEV1), Forced Vital Capacity (FVC) and FEV1/FVC), functional status, posture, and physical activity will be collected. Infection rate data for each resident for 4 months following completion of Breathing Room will be also collected.
- Being tested
- Breathing Room
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing RoomOther
8 total group classes performed twice a week over the course of 4 weeks, with IMTs utilized during the classes as well as 3 days outside of the class days at 5 sets of 5 breaths completed 5 times a day
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | The study will be single arm with intervention provided to all participants Receives: Other: Breathing Room |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in forced expiratory volume in one second (FEV1)
Spirometry testing will be performed using the MicroLoop battery operated portable spirometer to assess changes in forced expiratory volume in one second (FEV1) pre and post intervention
Measured: At baseline, after 2 weeks intervention, after 4 weeks intervention
Change in inspiratory muscle strength
MicroRPM Respiratory Pressure Meter will be used to assess changes in inspiratory muscle strength pre and post intervention. The sniff nasal inspiratory pressure (SNIP) scores will be recorded pre and post intervention.
Measured: At baseline, after 2 weeks intervention, after 4 weeks intervention
Change in functional capacity
The 6 Minute Walk Test will be used to assess the change in functional capacity and endurance pre and post intervention. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Measured: At baseline, after 2 weeks intervention, after 4 weeks intervention
Change in grip Strength
A JAMAR hand dynamometer will be used to assess changes in grip strength pre and post intervention. Measurements will be recorded using participants' dominant and non-dominant hand and repeated 3 times to determine maximum grip strength.
Measured: At baseline, after 2 weeks intervention, after 4 weeks intervention
Chane in kyphosis index
The flexicurve method will be used to measure the change in the kyphosis index pre and post intervention. To calculate the flexicurve kyphosis index, the apex kyphosis height (B) is divided by the length of the entire thoracic curve (X) and then multiplied by 100 (B/X × 100).
The flexicurve ruler, which is a malleable band of metal covered with plastic and approximately 60 cm in length, will be used. The ruler can be bent in only one plane and retains the shape to which it is bent. The subject will be instructed to stand up straight and as tall as possible, and the flexicurve ruler will be aligned to the spine from C7 to T12. The ruler will be then placed flat on paper and its outline will be traced.
Measured: At baseline, after 2 weeks intervention, after 4 weeks intervention
Change in forced vital capacity (FVC)
Spirometry testing will be performed using the MicroLoop battery operated portable spirometer to assess changes in forced vital capacity (FVC) pre and post intervention
Measured: At baseline, after 2 weeks intervention, after 4 weeks intervention
Change in forced expiratory volume in one second/forced vital capacity (FEV1/FVC) ratio
Spirometry testing will be performed using the MicroLoop battery operated portable spirometer to assess changes in forced expiratory volume in one second/forced vital capacity (FEV1/FVC) ratio pre and post intervention
Measured: At baseline, after 2 weeks intervention, after 4 weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start22 Feb 2022
- Primary completion29 Nov 2023
- Study completion29 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreathingStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Milwaukee
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murad Taani, University of Wisconsin, Milwaukee
- Investigators
- Murad H Taani, PhD, Principal investigator, University of Wisconsin, Milwaukee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05330780
- Sponsor's protocol ID
- 20.135
- Status last verified
- Nov 2023
- First submitted
- 7 Mar 2022
- Last updated
- 1 Dec 2023
- 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 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breathing Room Intervention to Achieve Better Lung Health in Older Adults
- ClinicalTrials.gov ID
- NCT05330780
- Acronym / sponsor ID
- 20.135
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of Wisconsin, MilwaukeeUniversity, hospital or other
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 29 Nov 2023 (actual)
- Study completion
- 29 Nov 2023 (actual)
- First posted
- 15 Apr 2022 (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.
This proposed study will evaluate whether a novel nonpharmacological intervention, Breathing Room, can improve lung function in the target population of older adults. Therefore, the primary aim of this pilot is to examine the effect of Breathing Room on inspiratory muscle strength, spirometry confirmed ventilatory function (Forced Expiratory Volume in one second (FEV1), Forced Vital Capacity (FVC) and FEV1/FVC), functional status, posture, physical activity, and lower respiratory infection rates.
Detailed description
Restrictive ventilatory patterns (RVPs) contribute to two prevalent problems in older adults: 1) the development of pneumonia and other lower respiratory infections; and 2) declining endurance for physical activity. The Breathing Room was developed as an exercise activity designed to open the thoracic cage, increase strength of the muscles of respiration with inspiratory muscle trainers, and optimize the breathing technique.
This will be a pretest-posttest design in which the outcomes are measured at baseline, and at two weeks and four weeks post start of Breathing Room intervention. Breathing Room classes will be held 3 times a week for 4 weeks (2 group classes, 1 individual reinforcement of Inspiratory Muscle Training [IMT] homework). The IMT homework includes 3 days 5 cycles of 5 breaths, each cycle followed by 2-minute rest. The IMT will be also utilized during the 2 group classes.
The group classes will be conducted with a maximum of 5 participants in each group. Data on inspiratory muscle strength, spirometry confirmed ventilatory function (Forced Expiratory Volume in one second (FEV1), Forced Vital Capacity (FVC) and FEV1/FVC), functional status, posture, and physical activity will be collected. Infection rate data for each resident for 4 months following completion of Breathing Room will be also collected.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Other: Breathing RoomThe study will be single arm with intervention provided to all participants |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- able to understand English
- baseline oxygen saturation level is above 85%
- spirometry-confirmed restrictive ventilatory pattern (forced vital capacity < 80% predicted, forced expiratory volume in 1 second/forced vital capacity ≥ 0.70
Key exclusion criteria (6 listed)
- have lung disease classified as restrictive or obstructive
- have unstable angina/myocardial infarction, eye or lung surgery within the previous 8 weeks or aneurysm
- have had major orthopedic surgery in the last 12 weeks
- have been told they have heart failure, take a diuretic "water pill" and have been told to restrict their salt and fluid intake (symptoms that coincide with Stage C of heart failure based on the American College of Cardiology and the American Heart Association classification system
- score in the severely impaired range on the Short Orientation Memory Concentration Test
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 |
|---|---|---|
| Breathing Room8 total group classes performed twice a week over the course of 4 weeks, with IMTs utilized during the classes as well as 3 days outside of the class days at 5 sets of 5 breaths completed 5 times a day | Other | All participants |
Primary outcome
Change in forced expiratory volume in one second (FEV1)
Time frame: At baseline, after 2 weeks intervention, after 4 weeks intervention
Spirometry testing will be performed using the MicroLoop battery operated portable spirometer to assess changes in forced expiratory volume in one second (FEV1) pre and post intervention
Change in inspiratory muscle strength
Time frame: At baseline, after 2 weeks intervention, after 4 weeks intervention
MicroRPM Respiratory Pressure Meter will be used to assess changes in inspiratory muscle strength pre and post intervention. The sniff nasal inspiratory pressure (SNIP) scores will be recorded pre and post intervention.
Change in functional capacity
Time frame: At baseline, after 2 weeks intervention, after 4 weeks intervention
The 6 Minute Walk Test will be used to assess the change in functional capacity and endurance pre and post intervention. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Change in grip Strength
Time frame: At baseline, after 2 weeks intervention, after 4 weeks intervention
A JAMAR hand dynamometer will be used to assess changes in grip strength pre and post intervention. Measurements will be recorded using participants' dominant and non-dominant hand and repeated 3 times to determine maximum grip strength.
Chane in kyphosis index
Time frame: At baseline, after 2 weeks intervention, after 4 weeks intervention
The flexicurve method will be used to measure the change in the kyphosis index pre and post intervention. To calculate the flexicurve kyphosis index, the apex kyphosis height (B) is divided by the length of the entire thoracic curve (X) and then multiplied by 100 (B/X × 100). The flexicurve ruler, which is a malleable band of metal covered with plastic and approximately 60 cm in length, will be used. The ruler can be bent in only one plane and retains the shape to which it is bent. The subject will be instructed to stand up straight and as tall as possible, and the flexicurve ruler will be aligned to the spine from C7 to T12. The ruler will be then placed flat on paper and its outline will be traced.
Change in forced vital capacity (FVC)
Time frame: At baseline, after 2 weeks intervention, after 4 weeks intervention
Spirometry testing will be performed using the MicroLoop battery operated portable spirometer to assess changes in forced vital capacity (FVC) pre and post intervention
Change in forced expiratory volume in one second/forced vital capacity (FEV1/FVC) ratio
Time frame: At baseline, after 2 weeks intervention, after 4 weeks intervention
Spirometry testing will be performed using the MicroLoop battery operated portable spirometer to assess changes in forced expiratory volume in one second/forced vital capacity (FEV1/FVC) ratio pre and post intervention
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 1 Dec 2023.
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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.
Murad H Taani, PhD principal investigator
University of Wisconsin, Milwaukee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing Room in people with Breathing and Aging, run by University of Wisconsin, Milwaukee at 1 site in United States.
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 1 Dec 2023. 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 United States. 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 in forced expiratory volume in one second (FEV1) (time frame: At baseline, after 2 weeks intervention, after 4 weeks intervention). The study lists 7 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 1 Dec 2023.