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The purpose is to evaluate feasibility and efficacy of Remote Ischemic Conditioning(RIC) as adjuvant therapy for Parkinson's Disease(PD). Sixty patients will be randomized into 2groups: RIC group receiving Remote Ischemic Conditioning except conventional therapy(n=30)and control group with conventional therapy (n=30).
Remote ischaemic conditioning (RIC) is a procedure whereby ischaemia is induced to a limb for short periods of time by inflating pressure cuffs around arms to above systolic pressures (mmHg). This procedure induce neurohormonal, systemic or vascular changes in the body. Such changes often result in improved collateralisation of blood supply to various areas of the body, as well as improved efficiencies of cellular metabolism. RIC has been shown to improve outcomes in patients with heart attacks, strokes, but is not investigated for PD. We argue that RIC may exert neuroprotective effect on PD due to its multiple mechanisms. The aim of the study is to evaluate the impact of RIC on long term outcomes in patients with PD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| remote ischemic conditioning | Experimental | remote ischemic conditioning is a physical strategy performed by an electric auto-control device with cuffs placed on bilateral arms: five cycles of 5-min inflation and 5-min deflation one or two times per day. The duration of the treatment is six months. |
|
| conventional therapy | Active Comparator | conventional therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote ischaemic conditioning | Device | 5 cycles of 5 minutes of upper limb ischaemia followed by 5 minutes of reperfusion. This will be delivered using a manual sphygmomanometer applied to the upper arm and activated to go through 5 such cycles automatically. The blood pressure cuff in the active treatment arm will inflate to 200 mmHg. RIC will be completed 1-2 times per day for six months. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Unified Parkinson's disease Rating Scale - Session III | The Unified Parkinson´s Disease Rating Scale Part Ⅲ is an accepted and validated scale for the assessment of motor function in Parkinson´s disease. Each of the 27 sub-items in the UPDRS III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. The total scores therefore ranges from 0 (Best score possible) to 108 (Worst score possible). | 24weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Unified Parkinson's disease Rating Scale - Session III | The Unified Parkinson´s Disease Rating Scale Part Ⅲ is an accepted and validated scale for the assessment of motor function in Parkinson´s disease. Each of the 27 sub-items in the UPDRS III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. The total scores therefore ranges from 0 (Best score possible) to 108 (Worst score possible). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chen Hui-Sheng | General Hospital of Shenyang Military Region | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of Northern Theater Command | Shenyang | 110840 | China |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Prospective randomized clinical trial
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a single-blind (outcomes assessor)
|
| conventional therapy | Other | conventional therapy |
|
| 12 weeks, 48 weeks |
| Changes on Depression | Assessment with Beck's depression inventory (BDI) . | 12 weeks, 24weeks, 48 weeks |
| Changes on Cognitive function | Rating with Montreal Cognitive Assessment (MOCA) | 12 weeks, 24weeks, 48 weeks |
| Changes on quality of life | It will be evaluated through the Parkinson Disease Questionnaire (PDQ-39). | 12 weeks, 24weeks, 48 weeks |
| Levodopa Equivalent Dose | Assessment with Research Team | 12 weeks, 24weeks, 48 weeks |
| frequency of adverse events | Adverse events to evaluate the safety and tolerability of Remote ischaemic conditioning | From screening up to 48 weeks |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |