Breathing Room Intervention to Achieve Better Lung Health in Older Adults

NCT05330780 | Completed

• 1 other identifier: 20.135
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Breathing; Aging

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (1)

All participants

EXPERIMENTAL

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

Other: Breathing Room

Interventions

Breathing Room 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

All participants

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Milwaukee: lead

Study Sites (1)

Ovation Communities (Jewish Home/Chai Point)

Milwaukee, Wisconsin, 53202, United States

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Murad H Taani, PhD

  University of Wisconsin, Milwaukee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: April 15, 2022
• Study Start: February 22, 2022
• Primary Completion: November 29, 2023
• Study Completion: November 29, 2023
• Last Updated: December 1, 2023

Record last verified: 2023-11

Locations

US (1)