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

NCT ID: NCT05287243

Last Updated: 2023-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2023-12-01

Brief Summary

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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

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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.

Conditions

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Parkinson Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Inspiratory Muscle Training

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

Group Type OTHER

inspiratory muscle training

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of St. Augustine for Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Kristen Barta

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kristen Barta, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of St. Augustine for Health Sciences

Locations

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University of St. Augustine for Health Sciences

Austin, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kristen Barta, DPT, PhD

Role: CONTACT

737-202-3341

Elizabeth Ardolino, PT, PhD

Role: CONTACT

737-202-3343

Facility Contacts

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Kristen Barta, DPT, PhD

Role: primary

737-202-3341

Germaine Ferreira, DPT

Role: backup

737-202-3356

Other Identifiers

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PT-0928-306

Identifier Type: -

Identifier Source: org_study_id

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