Effect of WB-EMS on Parkinson's Disease

Study Overview
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Brief Summary
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The aim is to establish adequate and suitable protocols for PD patients and to determine the WB-EMS effects on muscle strength, balance, walking, cognitive functions,neurotrophic factors and alpha-synuclein. Thirty-six PD patients, aged from 50 to 80 years, will be recruited and randomly assigned to two experimental groups (EGs and EGc) and one control group (CG), in order to perform dynamic movements with WB-EMS. EGs will undergo to 12-20 minutes of progressive supervised WB-EMS (4 sec. 85 HZ and 4 sec. rests) combined to light dynamic movements, two-time per week for 12/24 weeks. EGe will undergo to 12-20 minutes of progressive supervised WB-EMS 7 Hz) combined with cardiovascular training with rowing machine. CG will not perform any type of physical activity. Pre and post intervention assessment will be carried out on the following areas: physical assessment, neurocognitive, neurotrophic factors and alpha-synuclein assesments. A 3 months follow-up will be performed.

Official Title
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Effects of Combined Whole Body Electromiostimulation (WB-EMS) and Dynamic Movements on Motor and Cognitive Performance, Neurotrophic Factors and Alpha-synuclein in Parkinson's Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Other: Strenght training combined with WB-EMS
* Other: Cardiovascular training with WB-EMS
* Other: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age from 50 to 80 years old clinical diagnosis of parkinson's disease from 1 to 3 of Hoehn and Yahr Scale no partecipation to other physical activity program Exclusion Criteria: MMSE values < 24 inability to walk 6 minutes without assistance use of medications and other things that may affect cognitive and motor functions presence of contraindications in the use of WB-EMS

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Strength training + WB-EMS<br>Strength training combined with WB-EMS : 2 times/week for 20 minutes | Other: Strenght training combined with WB-EMS<br>* Bodyweight exercise training combined with WB-EMS (2 times/week) with a 85Hz electrical impulse<br>|
| Experimental: Cardiovascular training + WB-EMS<br>Cardiovascular training, using rowing machine, combined with WB-EMS : 2 times/week for 20 minutes | Other: Cardiovascular training with WB-EMS<br>* Cardiovascular training , using the rowing machine, combined with WB-EMS (2 times/week) with a 7Hz electrical impulse<br>|
| Active Comparator: Control group<br>No physical activity | Other: Control group<br>* No physical activity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| REPETITIONS NUMBER CHANGE | 30S ARM CURL TEST | 14 Weeks | 
| REPETITIONS NUMBER CHANGE | 30S SIT TO STAND TEST; | 14 Weeks | 
| TIME(S) CHANGE | SODA POP TEST ; | 14 Weeks | 
| TIME(S) CHANGE | 8 FEET UP AND GO TEST ; | 14 Weeks | 
| DISTANCE (M) CHANGE | 6 MINUTE WALKING TEST | 14 Weeks | 
| UPPER LIMB STRENGHT CHANGE | HAND GRIP TEST | 14 Weeks | 
| LOWER BODY FLEXIBILITY | CHAIR SIT AND REACH TEST | 14 Weeks | 
| BALANCE AND STABILITY TEST CHANGE | TINETTI BALANCE AND GAIT EVALUATION TEST | 14 Weeks | 
| NUMBER OF ERRORS CHANGE | STROOP TEST; | 14 Weeks | 
| NUMBER OF ERRORS CHANGE | REY AUDITORY VERBAL LEARNING TEST | 14 Weeks | 
| TIME(S) CHANGE | STROOP TEST | 14 Weeks | 
| TIME(S) CHANGE | TRAIL MAKING TEST CHANGE | 14 Weeks | 
| NEUROTROPHIC FACTORS CHANGE | BLOOD DRAW | 14 Weeks | 
| ALPHA-SYNUCLEIN CHANGE | BLOOD DRAW | 14 Weeks |