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Impact of Customized Respiratory Training on Cardiopulmonary Function in Parkison's Disease

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
inspiratory muscle training
Sponsored by
University of St. Augustine for Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

30 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • physician's diagnosis of Parkinson's disease

Exclusion Criteria:

  • people who are actively smoking, have a pacemaker, recent diagnosis of chronic obstructive pulmonary disease, bronchial asthma, active pulmonary disease within 1 month, or hospitalization within 2 months of time of study

Sites / Locations

  • University of St. Augustine for Health SciencesRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Inspiratory Muscle Training

Arm Description

involves the intervention portion of the study to improve strength of the cardiopulmonary system

Outcomes

Primary Outcome Measures

maximum expiratory pressure
measure of the maximum expiratory cardiopulmonary pressure
maximum inspiratory pressure
measure of the maximum inspiratory cardiopulmonary pressure
6 minute walk test
distance walked in 6 minutes
Fatigue Impact Scale
measure of a person's self report fatigue, ranges from 0-36 and higher score indicates greater impact of fatigue
heart rate
heart beats per minutes
respiratory rate
breaths per minute
blood pressure
measure of rest blood pressure

Secondary Outcome Measures

Full Information

First Posted
March 10, 2022
Last Updated
May 8, 2023
Sponsor
University of St. Augustine for Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05287243
Brief Title
Impact of Customized Respiratory Training on Cardiopulmonary Function in Parkison's Disease
Official Title
The Impact of a Customized Respiratory Muscle Training and Maintenance Program on Cardiopulmonary Function in People With Parkinson's Disease.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of St. Augustine for Health Sciences

4. Oversight

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

5. Study Description

Brief Summary
People with PD have lower cardiopulmonary function than their age matched peers. This decline can further impair a person's ability to participate in exercise and daily activities. Furthermore, the limitations in cardiopulmonary function can have a severe impact on mortality. There is evidence indicating the positive changes IMT can have on cardiopulmonary function in people with PD. Through intensive daily exercise people with PD have shown improvements in maximum inspiratory pressure and maximum expiratory pressure though detraining does occur when the intervention is not continued. The purpose of the proposed study is to determine if improvements in expiratory muscle strength can be maintained with a maintenance inspiratory muscle training program. The hypothesis is that there will be a significant change from baseline at the three and six month follow ups.
Detailed Description
Testers will complete the following outcome measures at the pretest: height, weight, maximum inspiratory pressure, maximum expiratory pressure, heart rate, blood pressure, respiratory rate, six-minute walk test, and Fatigue Impact Scale in person.17,18 Participants, and caregivers if necessary, will be educated on how to complete the intensive IMT program. The dosage will be IMT 3 times/day for 20 repetitions each with resistance set at 30% of baseline maximum for 12 weeks. This training will occur at home. Participants will record daily their completion of the intensive IMT. Investigators will contact participants weekly for follow-up of compliance and questions. Participants will be contacted either through email, text, or phone call, depending on their preference. After 12 weeks of intensive IMT training, the investigators will complete the first posttest which will include the following assessments: maximum inspiratory pressure, maximum expiratory pressure, heart rate, blood pressure, respiratory rate, six-minute walk test, and fatiguability scale in person. Participants, and caregivers if necessary, will be educated on the maintenance IMT program. The dosage for the maintenance program will be 33% of their intensive IMT program, which will result in IMT 1 time/day for 20 repetitions with resistance set at 30% of baseline maximum at the first posttest. The participants will continue the maintenance program for 12 more weeks. Participants will record daily their completion of the maintenance IMT program. Investigators will contact participants weekly for follow-up of compliance and questions. Participants will be contacted either through email, text, or phone call, depending on their preference. After the 12 weeks of maintenance IMT, the investigators will complete the second posttest which will include the following assessments: maximum inspiratory pressure, maximum expiratory pressure, heart rate, blood pressure, respiratory rate, six-minute walk test, and fatiguability scale in person. The participants will receive a $50 Amazon gift card upon the completion of second posttest. The participants will also be allowed to keep their IMT devices for continued use.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Inspiratory Muscle Training
Arm Type
Other
Arm Description
involves the intervention portion of the study to improve strength of the cardiopulmonary system
Intervention Type
Other
Intervention Name(s)
inspiratory muscle training
Intervention Description
Participants will complete inspiratory muscle training daily in their homes for 12 weeks. The dosage will depend on their initial maximum pressure. At the end of the 12 week intensive period, participants will reduce the inspiratory resistance by a third and continue a maintenance training for an additional 12 weeks.
Primary Outcome Measure Information:
Title
maximum expiratory pressure
Description
measure of the maximum expiratory cardiopulmonary pressure
Time Frame
5 minutes
Title
maximum inspiratory pressure
Description
measure of the maximum inspiratory cardiopulmonary pressure
Time Frame
5 minutes
Title
6 minute walk test
Description
distance walked in 6 minutes
Time Frame
8 minutes
Title
Fatigue Impact Scale
Description
measure of a person's self report fatigue, ranges from 0-36 and higher score indicates greater impact of fatigue
Time Frame
10 minutes
Title
heart rate
Description
heart beats per minutes
Time Frame
1 minute
Title
respiratory rate
Description
breaths per minute
Time Frame
1 minute
Title
blood pressure
Description
measure of rest blood pressure
Time Frame
1 minute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: physician's diagnosis of Parkinson's disease Exclusion Criteria: people who are actively smoking, have a pacemaker, recent diagnosis of chronic obstructive pulmonary disease, bronchial asthma, active pulmonary disease within 1 month, or hospitalization within 2 months of time of study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristen Barta, DPT, PhD
Phone
737-202-3341
Email
kbarta@usa.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Ardolino, PT, PhD
Phone
737-202-3343
Email
eardolino@usa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristen Barta, PT, PhD
Organizational Affiliation
The University of St. Augustine for Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of St. Augustine for Health Sciences
City
Austin
State/Province
Texas
ZIP/Postal Code
78739
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristen Barta, DPT, PhD
Phone
737-202-3341
Email
kbarta@usa.edu
First Name & Middle Initial & Last Name & Degree
Germaine Ferreira, DPT
Phone
737-202-3356
Email
gferreira@usa.edu
First Name & Middle Initial & Last Name & Degree
Nicole Borman, PT, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Impact of Customized Respiratory Training on Cardiopulmonary Function in Parkison's Disease

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