Respiratory Load Magnitude Estimation in PD

Aging Clinical Trial

Official title:

Magnitude Estimation of Respiratory Resistive Load in Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02202057
• Other study ID #: IRB201400183
• Status: Completed
• Phase: N/A
• First received: July 24, 2014
• Last updated: September 16, 2016
• Start date: September 2014
• Est. completion date: May 2016

Study information

• Verified date: September 2016
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine whether people with Parkinson's disease (PD) experience reduced perception of respiratory resistive loads versus healthy adults in the same age group. Further, the study will determine whether people with PD and trouble swallowing experience even more reduction of their perception of a respiratory resistive load.

Description:

Experimental design and procedures: This prospective experimental study will be completed in one study visit taking between 1 and 3 hours. Verbal and written informed consent will be obtained by qualified members of the investigative team. Following informed consent, all participants will complete a health history questionnaire to assess inclusion/exclusion criteria. For patients with PD the consenting investigator will review the electronic medical record to ensure inclusion/exclusion criteria are met.

The experimental protocol will consist of 1.) Baseline pulmonary function measures, 2.) Baseline measures of depression and apathy, 3.) Presentation of resistive inspiratory loads via respiratory equipment, and 4.) Rating the perceived magnitude of respiratory sensations as measured on a modified Borg scale (ranging from 6 - no breathing difficulty - to 20 - maximal difficulty). For patients with PD only, the investigators will also review results of the rehabilitation barium swallow study performed as part of their standard clinical care.

Baseline Pulmonary function measures: The forced expired volume in the first second (FEV1) of a forced vital capacity (FVC) exhalation will be measured for each participant. Maximum inspiratory pressure (PiMax) will be measured with a manometer. The PiMax test will be repeated until 3 measurements within 10% variation are obtained, with at least 1 minute rest between trials.

Baseline depression and apathy: There is a significant impact for emotion on respiratory perceptual ratings. As such, we will measure baseline depression and apathy scores using 2 validated scales, the Beck Depression Index (BDI) and Marin Apathy Index (MAI). These are not outcome measures, but will be used to determine exclusion criteria.

Should depression (17 or greater on BDI) be detected in a participant, that participant will be provided with contact information for the University of Florida (UF) psychiatry and psychology clinic and encouraged to seek further evaluation. In the case severe depression is detected (31 or greater on BDI) the participant will not continue with the study, and will be provided with contact information for the UF psychiatry and psychology clinic and encouraged to seek further evaluation.

Inspiratory resistive load presentation:

The participant will be seated in a chair, separated from the investigator and experimental apparatus. The participant will be instructed to "relax and breathe" through a facemask connected to a non-rebreathing valve in line with a differential pressure transducer. The inspiratory port of the valve will be connected to the resistive loading manifold. The manifold consists of 5 differential resistors ranging from 5 - 40 centimeters/water (cmH2O) of resistive pressure, separated by stoppered ports, as well as a no load condition. The load is applied by removing the stop for an entire inspiratory breath, and then replacing the port to continue resting tidal breathing. The pressure transducer will provide measures of mouth pressure and airflow, which will be digitized and recorded to a desk top computer using LabChart software. Following each loaded breath, the participant will provide an estimate of the perceived difficulty of breathing using a modified Borg scale.

Participants will be familiarized with the loads in a practice session prior to initiating the experimental protocol. During the experimental session, participants will listen to music of their choice in order to mask experimental sounds. The resistive loads will be applied in a randomized block design, with each loaded breath separated by at least three unloaded breaths. Two blocks will be completed with each load presented between 3 and 5 times within each block. Therefore, there will be a total of between 15 and 25 loaded breaths (3-5 loads x 5 presentations) per block. Participants will be instructed that when they see a small light flash briefly on the table in front of them (which they will be familiarized with prior to beginning the experiment) a resistive load will be applied to the next breath. Following the loaded breath, the participant will be asked to estimate the perceived difficulty of breathing on the Borg scale.

Rehabilitation barium swallow study: Participants with PD who are referred for a rehabilitation barium swallowing evaluation will be recruited for this study. Therefore, the swallowing evaluation is part of the normal clinical care of the patients and may vary based on the clinical necessity as judged by the treating speech-language pathologist. Generally, the standard clinical evaluation protocol consists of multiple swallows of thin liquid barium, pudding-thick barium, and a cracker or cookie coated with barium. For the purposes of this study, the researchers will review the most recently recorded swallow study and identify the worst observed penetration-aspiration (PA) score (ranging from 1-8, where 1 is no penetration or aspiration, and 8 is silent aspiration). The PA score will be recorded in order to determine whether the participant has trouble swallowing (scores of 3-8) or not (scores of 1 and 2).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 85 Years

Eligibility

Inclusion Criteria:

• Between the ages of 45 and 85

• Ability to provide informed consent

• Patient group: Diagnosis of PD, Hoehn and Yahr stages II - IV, by a UF Movement Disorders fellowship trained neurologist having completed a clinical assessment of each participant's PD severity and arriving at the diagnosis of PD by applying strict UF brain bank criteria.

• Healthy older adults: History of PD, or any other neurologic or neurodegenerative disease including stroke.

Exclusion Criteria:

• History of head and neck cancer, and radiation treatment to the head or neck

• History of breathing disorders or diseases (e.g. chronic obstructive pulmonary disease (COPD), asthma, lung cancer)

• History of smoking in the past 5 years, or for more than 5 years at any one time

• Severe cognitive deficits including dementia.

• Difficulty complying with protocol due to severe neuropsychological disorder (i.e., severe depression: 31 or greater on the BDI)

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aging
• Parkinson Disease
• Parkinson's Disease

Intervention

Other:
• Respiratory resistive load on inhalation
The participant will be seated in a chair, and will be instructed to "relax and breathe" through a facemask. Five respiratory resistive loads (5-40 cmH2O resistive pressure) will be applied between 3-5 times during inhalation. Following each loaded breath, participants will rate the perceived difficulty of breathing in.
• Fluoroscopic swallowing evaluation
Participants with PD only will receive a swallowing evaluation as part of their routine clinical care. Generally, the standard clinical evaluation protocol consists of multiple swallows of thin liquid barium, pudding-thick barium, and a cracker or cookie coated with barium. Results are reviewed by the treatment speech-language pathologist, and for the purposes of this study, the researchers will review the most recently recorded swallow study and identify the worst observed penetration-aspiration (PA) score.

Locations

Country	Name	City	State
United States	University of Florida Center for Movement Disorders and Neurorestoration	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Total amount of air that can be expired from the lungs	Spirometry will be used to determine the forced vital capacity, and forced expiratory volume in 1 second.	Baseline	No
Other	The maximum amount of inspiratory pressure	A manometer will be used to measure the maximum inspiratory pressure each participant can generate.	Baseline	No
Other	Feelings of sadness or depression	The Beck Depression Index (BDI) is a 21-item questionnaire that will be completed by each participant. Scores range from 1-10 (normal ups and downs) to over 40 (extreme depression).	Baseline	No
Other	Feeling apathetic, or indifferent.	The Marin apathy index (MAI) is a 14-item questionnaire with scores ranging from 0 (not at all) to 3 (a lot) for each item.	Baseline	No
Other	Ability to swallow liquids and solids without material entering the airway	The penetration-aspiration scale will be used by the investigators to determine whether material enters the airway during swallowing. This ranges from 1 (no penetration/aspiration) to 8 (silent aspiration).	Baseline	Yes
Primary	Perceived difficulty inhaling against each respiratory resistive load.	Participants will rate the level of difficulty when inhaling against different levels of resistive load. The Borg scale ranges from 6-20, where 6 is 'no difficulty' and 20 is 'maximal difficulty.'	Baseline	No
Secondary	The amount of pressure generated while inhaling against each resistive load	The mouth pressure will be measured while each participant is inhaling through the facemask, against each resistive load level. This will be measured in cmH2O	Baseline	No