Breathing Room Intervention to Achieve Better Lung Health in Older Adults

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.

Study Overview

• Status: Completed
• Conditions: Aging; Breathing
• Intervention / Treatment: Other: Breathing Room

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 Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53202
      • Ovation Communities (Jewish Home/Chai Point)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All participants; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	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.	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.	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	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	At baseline, after 2 weeks intervention, after 4 weeks intervention

Collaborators and Investigators

• Sponsor: University of Wisconsin, Milwaukee
• Investigators: Principal Investigator: Murad H Taani, PhD, University of Wisconsin, Milwaukee

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2022
• Primary Completion (Actual): November 29, 2023
• Study Completion (Actual): November 29, 2023

Study Registration Dates

• First Submitted: March 7, 2022
• First Submitted That Met QC Criteria: April 14, 2022
• First Posted (Actual): April 15, 2022

Study Record Updates

• Last Update Posted (Actual): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: 20.135

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No