Clinical trial NCT05330780: Breathing Room Intervention to Achieve Better Lung Health in Older Adults
Official title: Breathing Room Intervention to Achieve Better Lung Health in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breathing
Aging
Lead sponsor: University of Wisconsin, Milwaukee
Sponsor class: OTHER
First posted: 2022-04-15
Enrollment: 46
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in forced expiratory volume in one second (FEV1)
timeFrame: At baseline, after 2 weeks intervention, after 4 weeks intervention
measure: Change in inspiratory muscle strength
timeFrame: At baseline, after 2 weeks intervention, after 4 weeks intervention
measure: Change in functional capacity
timeFrame: At baseline, after 2 weeks intervention, after 4 weeks intervention
measure: Change in grip Strength
timeFrame: At baseline, after 2 weeks intervention, after 4 weeks intervention
measure: Chane in kyphosis index
timeFrame: At baseline, after 2 weeks intervention, after 4 weeks intervention
measure: Change in forced vital capacity (FVC)
timeFrame: At baseline, after 2 weeks intervention, after 4 weeks intervention
measure: Change in forced expiratory volume in one second/forced vital capacity (FEV1/FVC) ratio
timeFrame: At baseline, after 2 weeks intervention, after 4 weeks intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Ovation Communities (Jewish Home/Chai Point)
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Milwaukee
name: Murad H Taani, PhD
role: PRINCIPAL_INVESTIGATOR
References: