An interventional study of Breathing Room in Breathing and Aging, sponsored by University of Wisconsin, Milwaukee. Completed at 1 site in United States. Open to participants aged 45 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-01.
Sponsored by University of Wisconsin, Milwaukee · Not applicable, Interventional, and Other
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.
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.
University of Wisconsin, Milwaukee is the lead sponsor of 33 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study will be single arm with intervention provided to all participants
Other: Breathing Room
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
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: At baseline, after 2 weeks intervention, after 4 weeks intervention
Ran from Feb 2022 to primary completion in Nov 2023, 21 months.
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University of Wisconsin, Milwaukee