Breathing Room Intervention to Achieve Better Lung Health in Older Adults

NCT ID: NCT05330780

Last Updated: 2023-12-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-22
• Study Completion Date: 2023-11-29

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.

Conditions

Breathing; Aging

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

All participants

The study will be single arm with intervention provided to all participants

Group Type: EXPERIMENTAL

Breathing Room

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Wisconsin, Milwaukee

OTHER

Sponsor Role: lead

Responsible Party

Murad Taani

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Murad H Taani, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Milwaukee

Locations

Ovation Communities (Jewish Home/Chai Point)

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

20.135

Identifier Type: -

Identifier Source: org_study_id