Cardiovascular Effects of Exercise in Patients With Parkinson's Disease

NCT03343574 | Active Not Recruiting

• 1 other identifier: HSREB109386
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease; Orthostatic Hypotension

Keywords

Parkinson's Disease; Neurogenic orthostatic hypotension; Orthostatic intolerance; Exercise; Abdominal binder; Autonomic dysfunction; Dizziness; Physical Therapy; Blood pressure; Heart rate; Autonomic function testing; Neurology; Falls risk; Autonomic Nervous System; Autonomic reflex screening; Cerebral blood flow; Cerebral perfusion; Activities of Daily Living

Outcome Measures

Primary Outcomes (1)

• Blood Pressure

  Continuous non-invasive monitoring using a finger cuff. Blood Pressure will be measured in millimetres of Mercury (mmHg).

  up to 3 hours for each visit. A total of 2 visits are expected for each participant.

Secondary Outcomes (8)

• Heart Rate

  up to 3 hours for each visit. A total of 2 visits are expected for each participant.

• Composite Autonomic Severity Score

  Up to one hour for autonomic reflex testing for each visit. A total of 2 visits are expected for each participant.

• Middle Cerebral Artery flow velocity

  Up to three hours for each visit. A total of 2 visits are expected for each participant.

• Changes in the ratio between oxy- and deoxy-hemoglobin

  Up to three hours for each visit. A total of 2 visits are expected for each participant.

• The Composite Autonomic Symptom Scale (COMPASS)

  20 minutes

Study Arms (2)

Abdominal Strengthening Exercise

EXPERIMENTAL

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

Routine Care

NO INTERVENTION

All participants in this group shall continue to obtain routine care for the management of Parkinson's Disease.

Interventions

Abdominal Strengthening Exercise OTHER

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.

Also known as: Abdominal Exercise

Abdominal Strengthening Exercise

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of Parkinson's Disease;
• Between stages 2 and 4 of Hoehn and Yahr classification of Parkinson's Disease;
• Male or female; and
• Age 40-90 years.

You may not qualify if:

• Therapy with anticholinergic, alpha- and beta-adrenergic antagonists or other medication, which could interfere with the regulation of blood pressure and heart rate. These medications are commonly used to treat conditions such as irregular heartbeats, high blood pressure, heart failure, urinary incontinence and other medical conditions (e.g. Alprazolam (Xanax), Amantadine (Symmetrel), Baclofen, Cimetidine, Codeine. Doxazosin, Prazosin, Atenolol (Tenormin), Bisoprolol (Zebeta, also sold as Ziac), Carvedilol (Coreg), Propranolol (Inderal, Inderal LA);
• Clinically significant coronary artery disease;
• Presence of nerve damage in the peripheral nervous system;
• Pregnant or breast feeding females; and
• The presence of failure of other organ systems or diseases that can affect autonomic function or the participant's ability to cooperate. These include dementia, specific tumors, heart failure, hypertension, renal or hepatic disease, severe anemia, alcoholism, hypothyroidism, surgical procedures where the nerves of the sympathetic nervous system have been cut, or cerebrovascular disease.

Sponsors & Collaborators

• Faizan Ahmed: lead

Study Sites (1)

University Hospital

London, Ontario, N6A 5A5, Canada

Location

Related Publications (7)

• Dubow JS. Autonomic dysfunction in Parkinson's disease. Dis Mon. 2007 May;53(5):265-74. doi: 10.1016/j.disamonth.2007.02.004. No abstract available.

  PMID: 17656188 BACKGROUND

• Ziemssen T, Reichmann H. Cardiovascular autonomic dysfunction in Parkinson's disease. J Neurol Sci. 2010 Feb 15;289(1-2):74-80. doi: 10.1016/j.jns.2009.08.031. Epub 2009 Sep 8.

  PMID: 19740484 BACKGROUND

• Diop M, St Lawrence K. Improving the depth sensitivity of time-resolved measurements by extracting the distribution of times-of-flight. Biomed Opt Express. 2013 Mar 1;4(3):447-59. doi: 10.1364/BOE.4.000447. Epub 2013 Feb 15.

  PMID: 23504445 BACKGROUND

• Karvonen J, Vuorimaa T. Heart rate and exercise intensity during sports activities. Practical application. Sports Med. 1988 May;5(5):303-11. doi: 10.2165/00007256-198805050-00002.

  PMID: 3387734 BACKGROUND

• Pina IL, Balady GJ, Hanson P, Labovitz AJ, Madonna DW, Myers J. Guidelines for clinical exercise testing laboratories. A statement for healthcare professionals from the Committee on Exercise and Cardiac Rehabilitation, American Heart Association. Circulation. 1995 Feb 1;91(3):912-21. doi: 10.1161/01.cir.91.3.912. No abstract available.

  PMID: 7828326 BACKGROUND

• Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

  PMID: 38588457 DERIVED

• Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

  PMID: 36602886 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Hypotension, Orthostatic; Orthostatic Intolerance; Motor Activity; Primary Dysautonomias; Dizziness

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Autonomic Nervous System Diseases; Hypotension; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Sensation Disorders

Study Officials

• Mandar Jog, MD

  Western University, London, ON

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study coordinator

Study Record Dates

• First Submitted: November 10, 2017
• First Posted: November 17, 2017
• Study Start: December 1, 2017
• Primary Completion: August 30, 2020
• Study Completion: November 28, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Locations

CA (1)