Exercise and Its Cardiovascular Effects in Patients of Parkinson's Disease With Cardiovascular Autonomic Dysfunction
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Blood Pressure
研究概览
简要总结
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.
详细描述
Parkinson's Disease (PD) is associated with abnormal control of the cardiovascular system in up to 50% of patients. The cardiovascular autonomic dysfunction is a result of abnormal regulation of the cardiovascular system by the autonomic nervous system (ANS). It manifests as orthostatic hypotension, supine hypertension, and may possibly involve abnormal heart rate and rhythm, as well as abnormal haemodynamic responses to exercise. Orthostatic hypotension is a sudden decline in the blood pressure (BP) as a result of assumption of more upright posture like standing up and may present as a generalized weakness, light-headedness, mental "clouding" up to syncope. Moreover, the stress of exercise may worsen the manifestation of an asymptomatic cardiovascular autonomic dysfunction, resulting in decreased balance control which may render the patient unable to exercise and/or predispose the patient to a higher risk of falls, decreased ability in activities of daily living (ADLs) and confusion. Falls in elderly patients, which constitute the majority of patients with PD, are potentially dangerous and disabling. However, the response of the cardiovascular system to neither the routinely prescribed physiotherapeutic exercises nor the routine physical activities of the patients of PD are known. Thus, due to lack of any research data on the effects of these exercises/activities it cannot be determined whether certain components of the routine physiotherapy treatment are appropriate and safe for the patient with regard to the development or worsening of cardiovascular autonomic dysfunction. The same is true for some of the patient's ADLs that may trigger signs and symptoms of cardiovascular autonomic dysfunction. The researchers, therefore, intend to investigate the same.
This research has two parts - stage 1 and stage 2. Only stage 2 is a randomized controlled trial. The specific objectives pertaining to each stage are:
Stage 1 - To analyze the spectrum of cardiovascular dysfunction in patients with PD -
- As determined by the autonomic reflex screening; and
- In response to the different postures/activities/exercises and to wearing an abdominal binder.
Stage 2 - To investigate whether strengthening of the abdominal muscles can be an effective strategy to improve cardiovascular system's ability to counter the development of OH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Abdominal Strengthening Exercise (Other)
Routine Care
All participants in this group shall continue to obtain routine care for the management of Parkinson's Disease.
结局指标
主要结局
Blood Pressure
时间窗: 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).
次要结局
- Heart Rate(up to 3 hours for each visit. A total of 2 visits are expected for each participant.)
- Orthostatic Discriminant and Severity Scores(10 minutes)
- 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.)
- 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.)
- The Composite Autonomic Symptom Scale (COMPASS)(20 minutes)
- Dizziness Handicap Inventory score(5 minutes)
- Orthostatic Hypotension Questionnaire Score(5 minutes)
研究者
Faizan Ahmed
Study coordinator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's