NCT05287243

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 18, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

May 9, 2023

Status Verified

May 1, 2023

Enrollment Period

1.1 years

First QC Date

March 10, 2022

Last Update Submit

May 8, 2023

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (7)

  • maximum expiratory pressure

    measure of the maximum expiratory cardiopulmonary pressure

    5 minutes

  • maximum inspiratory pressure

    measure of the maximum inspiratory cardiopulmonary pressure

    5 minutes

  • 6 minute walk test

    distance walked in 6 minutes

    8 minutes

  • 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

  • heart rate

    heart beats per minutes

    1 minute

  • respiratory rate

    breaths per minute

    1 minute

  • blood pressure

    measure of rest blood pressure

    1 minute

Study Arms (1)

Inspiratory Muscle Training

OTHER

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

Other: inspiratory muscle training

Interventions

inspiratory muscle trainingOTHER

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.

Inspiratory Muscle Training

Eligibility Criteria

Age30 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • physician's diagnosis of Parkinson's disease

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of St. Augustine for Health Sciences

Austin, Texas, 78739, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Kristen Barta, PT, PhD

    The University of St. Augustine for Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristen Barta, DPT, PhD

CONTACT

737-202-3341kbarta@usa.edu

Elizabeth Ardolino, PT, PhD

CONTACT

737-202-3343eardolino@usa.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 10, 2022

First Posted

March 18, 2022

Study Start

November 1, 2022

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

May 9, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)