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Breathing Room Intervention to Achieve Better Lung Health in Older Adults

Primary Purpose

Breathing, Aging

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Breathing Room
Sponsored by
University of Wisconsin, Milwaukee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breathing

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ovation Communities (Jewish Home/Chai Point)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All participants

Arm Description

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

Outcomes

Primary Outcome Measures

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
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.
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.
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.
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.
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
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

Secondary Outcome Measures

Full Information

First Posted
March 7, 2022
Last Updated
May 9, 2023
Sponsor
University of Wisconsin, Milwaukee
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1. Study Identification

Unique Protocol Identification Number
NCT05330780
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2022 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Wisconsin, Milwaukee

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breathing, Aging

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
All participants
Arm Type
Experimental
Arm Description
The study will be single arm with intervention provided to all participants
Intervention Type
Other
Intervention Name(s)
Breathing Room
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in forced expiratory volume in one second (FEV1)
Description
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
Title
Change in inspiratory muscle strength
Description
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
Title
Change in functional capacity
Description
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
Title
Change in grip Strength
Description
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
Title
Chane in kyphosis index
Description
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
Title
Change in forced vital capacity (FVC)
Description
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
Title
Change in forced expiratory volume in one second/forced vital capacity (FEV1/FVC) ratio
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Murad Taani, PhD
Phone
575-571-5945
Email
mhtaani@uwm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kimberly Bassindale, DPT
Phone
262-391-1184
Email
kdembinski@ovation.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murad H Taani, PhD
Organizational Affiliation
University of Wisconsin, Milwaukee
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ovation Communities (Jewish Home/Chai Point)
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Murad Taani, PhD
Phone
575-571-5945
Email
mhtaani@uwm.edu
First Name & Middle Initial & Last Name & Degree
Kimberly Bassindale, DPT
Phone
262-391-1184
Email
kdembinski@ovation.org

12. IPD Sharing Statement

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Breathing Room Intervention to Achieve Better Lung Health in Older Adults

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