Recruiting

Customized Respiratory Training

Sponsor:

University of St. Augustine for Health Sciences

Code:

NCT05287243

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

inspiratory muscle training

Study Details

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.

Conditions

Parkinson Disease

Study ID

NCT05287243

Start date

Nov 1, 2022

Status verified date

May, 2023

Completion date

Dec 1, 2023

Anticipated

Primary completion date

Dec 1, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Inspiratory Muscle Training

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

Interventions

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.

Primary outcome measure

  • maximum expiratory pressure [ Time Frame: 5 minutes ]
  • maximum inspiratory pressure [ Time Frame: 5 minutes ]
  • 6 minute walk test [ Time Frame: 8 minutes ]
  • Fatigue Impact Scale [ Time Frame: 10 minutes ]
  • heart rate [ Time Frame: 1 minute ]
  • respiratory rate [ Time Frame: 1 minute ]
  • blood pressure [ Time Frame: 1 minute ]

Central Contacts and Locations

Central contacts

Kristen Barta, DPT, PhD

737-202-3341kbarta@usa.edu

Elizabeth Ardolino, PT, PhD

737-202-3343eardolino@usa.edu

Locations

University of St. Augustine for Health Sciences

Recruiting

Austin, Texas, United States, 78739

Contacts

Kristen Barta, DPT, PhD

737-202-3341kbarta@usa.edu

Germaine Ferreira, DPT

737-202-3356gferreira@usa.edu

More Information

Sponsor

University of St. Augustine for Health Sciences

Last update posted

May 9, 2023

Last verified

May, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of St. Augustine for Health Sciences on 2023-05-09.