Parkinson DiseaseNCT05287243
Impact of Customized Respiratory Training on Cardiopulmonary Function in Parkison's Disease
A study testing inspiratory muscle training in people with Parkinson Disease, run by University of St. Augustine for Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 30 to 99 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- inspiratory muscle training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2022to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- physician's diagnosis of Parkinson's disease
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of St. Augustine for Health Sciences
Austin, Texas, 78739
Kristen Barta, DPT, PhD, 737-202-3341, kbarta@usa.edu
Germaine Ferreira, DPT, 737-202-3356, gferreira@usa.edu
About this study
Official title: The Impact of a Customized Respiratory Muscle Training and Maintenance Program on Cardiopulmonary Function in People With Parkinson's Disease.
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- inspiratory muscle training
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory Muscle Training | Other | involves the intervention portion of the study to improve strength of the cardiopulmonary system Receives: Other: inspiratory muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum expiratory pressure
measure of the maximum expiratory cardiopulmonary pressure
Measured: 5 minutes
maximum inspiratory pressure
measure of the maximum inspiratory cardiopulmonary pressure
Measured: 5 minutes
6 minute walk test
distance walked in 6 minutes
Measured: 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
Measured: 10 minutes
heart rate
heart beats per minutes
Measured: 1 minute
respiratory rate
breaths per minute
Measured: 1 minute
blood pressure
measure of rest blood pressure
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start1 Nov 2022
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of St. Augustine for Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristen Barta, University of St. Augustine for Health Sciences
- Investigators
- Kristen Barta, PT, PhD, Principal investigator, The University of St. Augustine for Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05287243
- Sponsor's protocol ID
- PT-0928-306
- Status last verified
- May 2023
- First submitted
- 10 Mar 2022
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Customized Respiratory Muscle Training and Maintenance Program on Cardiopulmonary Function in People With Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT05287243
- Acronym / sponsor ID
- PT-0928-306
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of St. Augustine for Health SciencesUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 18 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inspiratory Muscle Training | Other | Other: inspiratory muscle traininginvolves the intervention portion of the study to improve strength of the cardiopulmonary system |
Who may qualify
- Ages
- 30 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- physician's diagnosis of Parkinson's disease
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inspiratory muscle trainingParticipants 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. | Other | Inspiratory Muscle Training |
Primary outcome
maximum expiratory pressure
Time frame: 5 minutes
measure of the maximum expiratory cardiopulmonary pressure
maximum inspiratory pressure
Time frame: 5 minutes
measure of the maximum inspiratory cardiopulmonary pressure
6 minute walk test
Time frame: 8 minutes
distance walked in 6 minutes
Fatigue Impact Scale
Time frame: 10 minutes
measure of a person's self report fatigue, ranges from 0-36 and higher score indicates greater impact of fatigue
heart rate
Time frame: 1 minute
heart beats per minutes
respiratory rate
Time frame: 1 minute
breaths per minute
blood pressure
Time frame: 1 minute
measure of rest blood pressure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristen Barta, PT, PhD principal investigator
The University of St. Augustine for Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inspiratory muscle training in people with Parkinson Disease, run by University of St. Augustine for Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kristen Barta, DPT, PhD (737-202-3341, kbarta@usa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximum expiratory pressure (time frame: 5 minutes). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.