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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05287243
Enrollment
40
Registered
2022-03-18
Start date
2022-11-01
Completion date
2023-12-01
Last updated
2023-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

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.

Interventions

OTHERinspiratory 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.

Sponsors

University of St. Augustine for Health Sciences
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
maximum expiratory pressure5 minutesmeasure of the maximum expiratory cardiopulmonary pressure
maximum inspiratory pressure5 minutesmeasure of the maximum inspiratory cardiopulmonary pressure
6 minute walk test8 minutesdistance walked in 6 minutes
Fatigue Impact Scale10 minutesmeasure of a person's self report fatigue, ranges from 0-36 and higher score indicates greater impact of fatigue
heart rate1 minuteheart beats per minutes
respiratory rate1 minutebreaths per minute
blood pressure1 minutemeasure of rest blood pressure

Countries

United States

Contacts

Primary ContactKristen Barta, DPT, PhD
kbarta@usa.edu737-202-3341
Backup ContactElizabeth Ardolino, PT, PhD
eardolino@usa.edu737-202-3343

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026