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

Parkinson Disease Clinical Trial

Official title:

The Impact of a Customized Respiratory Muscle Training and Maintenance Program on Cardiopulmonary Function in People With Parkinson's Disease.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05287243
• Other study ID #: PT-0928-306
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: May 2023
• Source: University of St. Augustine for Health Sciences
• Contact: Kristen Barta, DPT, PhD
• Phone: 737-202-3341
• Email: kbarta[@]usa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• inspiratory muscle training
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.

Locations

Country	Name	City	State
United States	University of St. Augustine for Health Sciences	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of St. Augustine for Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maximum expiratory pressure	measure of the maximum expiratory cardiopulmonary pressure	5 minutes
Primary	maximum inspiratory pressure	measure of the maximum inspiratory cardiopulmonary pressure	5 minutes
Primary	6 minute walk test	distance walked in 6 minutes	8 minutes
Primary	Fatigue Impact Scale	measure of a person's self report fatigue, ranges from 0-36 and higher score indicates greater impact of fatigue	10 minutes
Primary	heart rate	heart beats per minutes	1 minute
Primary	respiratory rate	breaths per minute	1 minute
Primary	blood pressure	measure of rest blood pressure	1 minute