Cardiovascular Effects of Exercise in Patients With Parkinson's Disease
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|ClinicalTrials.gov Identifier: NCT03343574|
Recruitment Status : Active, not recruiting
First Posted : November 17, 2017
Last Update Posted : February 21, 2021
Abnormalities in the regulation of cardiovascular system due to autonomic nervous system (ANS) dysfunction may lead to a sudden decline in blood pressure (BP) upon standing, sitting or performing activities/exercises in patients with Parkinson's Disease (PD). This sudden decline in BP is known as 'orthostatic hypotension' (OH). OH may cause dizziness and/or black-outs, which may increase the risk of falls. As falls are potentially dangerous and disabling, it is important to prevent their occurrence. Keeping BP within normal range upon change of posture or with activities is therefore of great significance. Pooling of blood in the abdominal blood vessels may be one of the reasons for OH to happen. This research focuses on strengthening the weak abdominal muscles of the participants so that the compressive action of these muscles can help decrease such pooling. Therefore, the researchers hypothesize that strengthening the abdominal muscles shall prove to be helpful in controlling orthostatic hypotension by preventing a sudden decline in blood pressure of the participants upon assumption of upright posture. The secondary hypothesis is that there exists a significant difference in the response of the cardiovascular system to a variety of postures/activities/exercises when patients of PD having cardiovascular autonomic dysfunction are compared with patients of PD with normal ANS function.
This study has two parts - stage 1 and stage 2. Only stage 2 is a randomized controlled trial. Stage 1 involves testing the functional integrity of the autonomic nervous system, and observation of the cardiovascular responses of the participants to different postures/activities/exercises and to the use of an abdominal binder (which is a compressive garment worn around the abdomen). Findings of stage 1 shall help the researchers better understand the cardiovascular abnormalities present in such patients at rest and with activity. Stage 2 involves strength training for the abdominal muscles that is to be done by the participant at her/his residence for a period of 3 months followed by a second round of autonomic function testing and observation of the cardiovascular responses to the use of abdominal binder. Findings of stage 2 shall help the researchers determine if strength training of the abdominal muscles can be a useful strategy to counter the cardiovascular abnormalities found in the participants during the testing in stage 1.
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease Orthostatic Hypotension||Other: Abdominal Strengthening Exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Exercise and Its Cardiovascular Effects in Patients of Parkinson's Disease With Cardiovascular Autonomic Dysfunction|
|Actual Study Start Date :||December 1, 2017|
|Actual Primary Completion Date :||August 30, 2020|
|Estimated Study Completion Date :||November 28, 2021|
Experimental: Abdominal Strengthening Exercise
All participants in this arm shall perform exercises for the strengthening of abdominal muscles for a period of three months in addition to the routine care provided to them for the management of Parkinson's Disease. The exercises are structured and need to be performed on a routine basis.
Other: Abdominal Strengthening Exercise
Abdominal strengthening exercises involve the muscles of the abdomen. These exercises are to be done in different positions like lying down (recumbent) position, sitting and standing positions. The person performing the exercise contracts the abdominal muscles for a predetermined number of times (up to 10 times), holds the contracted position for up to 10 seconds and then releases the contraction to relax and return to the original state. These exercises are done for three times everyday.
Other Name: Abdominal Exercise
No Intervention: Routine Care
All participants in this group shall continue to obtain routine care for the management of Parkinson's Disease.
- Blood Pressure [ Time Frame: up to 3 hours for each visit. A total of 2 visits are expected for each participant. ]Continuous non-invasive monitoring using a finger cuff. Blood Pressure will be measured in millimetres of Mercury (mmHg).
- Heart Rate [ Time Frame: up to 3 hours for each visit. A total of 2 visits are expected for each participant. ]Continuous non-invasive monitoring of rate and rhythm of the beating of the heart. It will be measured in beats per minute.
- Composite Autonomic Severity Score [ Time Frame: Up to one hour for autonomic reflex testing for each visit. A total of 2 visits are expected for each participant. ]This score is the result of the autonomic reflex testing. It combines the sweat volume (in micro-litres), heart rate and blood pressure findings from the autonomic reflex test to provide a discrete numerical value.
- Middle Cerebral Artery flow velocity [ Time Frame: Up to three hours for each visit. A total of 2 visits are expected for each participant. ]Continuous monitoring and periodical recording of blood flow velocity in the Middle Cerebral Artery of the brain. It is based on ultrasound technology and is measured on both sides of the head of the participant (left and right sides). The blood flow velocity is expressed in centimetres per second.
- Changes in the ratio between oxy- and deoxy-hemoglobin [ Time Frame: Up to three hours for each visit. A total of 2 visits are expected for each participant. ]This score is obtained using the Functional Near-Infrared Spectroscopy. This is expressed as a numerical value which has no unit of measurement.
- The Composite Autonomic Symptom Scale (COMPASS) [ Time Frame: 20 minutes ]The Autonomic Symptom Profile Questionnaire uses the COMPASS scale to generates a score that is obtained using the Autonomic Symptom Profile questionnaire (which is a paper-based self-completed (complete by the patient) questionnaire containing 169 items). The results are expressed in numerical values. The questionnaire evaluates 10 domains related to the functioning of the autonomic nervous system. Higher scores indicate more or worse symptoms. The maximum score for men can be 200 and for women it can be 170, in addition to the 12 questions pertaining to psychosomatic problems where each question carries a maximum score of 10. The autonomic symptom profile questionnaire is used to determine the severity of the symptoms of autonomic nervous system dysfunction.
- Orthostatic Discriminant and Severity Scores [ Time Frame: 10 minutes ]These scores are obtained using the Orthostatic Discriminant and Severity Scale (ODSS). They are expressed in numerical values. ODSS scale will be used to quantify and discriminate orthostatic symptoms (i.e. symptoms manifested due to low blood pressure upon standing up) from non-orthostatic symptoms (i.e. symptoms which are not caused by low blood pressure upon standing up). ODSS questionnaire is a self-completed instrument and contains 33 questions. There are two types of questions - those that target orthostatic symptoms and others that target non-orthostatic symptoms, thus generating a numerical 'orthostatic score' and a numerical 'non-orthostatic score', respectively. The maximum and minimum orthostatic scores can be 107 and 7, respectively. The maximum and minimum non-orthostatic scores can be 72 and 7, respectively. Higher scores indicate more or worse affected condition of the research participant.
- Orthostatic Hypotension Questionnaire Score [ Time Frame: 5 minutes ]This score is obtained using the Orthostatic Hypotension Questionnaire. It is expressed in numerical values. The maximum score can be 100 and the minimum score can be zero. This questionnaire is self-completed by the research participant and it is used to determine how low blood pressure symptoms affect the research participants daily life. Higher scores indicate more or worse affected condition of the research participant.
- Dizziness Handicap Inventory score [ Time Frame: 5 minutes ]This score is obtained using the Dizziness Handicap Inventory. It is expressed in numerical values. The Dizziness Handicap Inventory is a self-completed instrument designed to determine the difficulties the research participant may be facing because of his/her problem of dizziness. It has two parts. The first part has 25 questions divided into 3 domains. The maximum score for part 1 can be 100 and the minimum score can be zero. Part 2 of this instrument has one question with six possible answers. The maximum score for part 2 can 5 and the minimum score can be zero. Higher scores indicate that the research participant is facing greater difficulties in his/her daily life due to the presence of dizziness.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03343574
|London, Ontario, Canada, N6A 5A5|
|Principal Investigator:||Mandar Jog, MD||Western University, London, ON|