Effect of WB-EMS on Parkinson's Disease

Not Applicable

• Conditions: Parkinson Disease
• Interventions: Other: Strenght training combined with WB-EMS; Other: Control group; Other: Cardiovascular training with WB-EMS

• Registration Number: NCT04878679
• Lead Sponsor: Università degli studi di Roma Foro Italico

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-15
• Study First Submitted: 2021-04-21
• Study First Submitted QC: 2021-05-05
• Study First Posted: 2021-05-07
• Primary Completion: 2022-09-23
• Study Completion: 2023-04-30
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-10
• Last Update Posted: 2023-05-11

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
"Strength training + WB-EMS"	Strenght training combined with WB-EMS	Strength training combined with WB-EMS : 2 times/week for 20 minutes
Control group	Control group	No physical activity
Cardiovascular training + WB-EMS	Cardiovascular training with WB-EMS	Cardiovascular training, using rowing machine, combined with WB-EMS : 2 times/week for 20 minutes

Primary Outcome Measures

Name	Time	Method
ALPHA-SYNUCLEIN CHANGE	14 Weeks	BLOOD DRAW
REPETITIONS NUMBER CHANGE	14 Weeks	30S SIT TO STAND TEST;
TIME(S) CHANGE	14 Weeks	TRAIL MAKING TEST CHANGE
DISTANCE (M) CHANGE	14 Weeks	6 MINUTE WALKING TEST
UPPER LIMB STRENGHT CHANGE	14 Weeks	HAND GRIP TEST
LOWER BODY FLEXIBILITY	14 Weeks	CHAIR SIT AND REACH TEST
BALANCE AND STABILITY TEST CHANGE	14 Weeks	TINETTI BALANCE AND GAIT EVALUATION TEST
NUMBER OF ERRORS CHANGE	14 Weeks	REY AUDITORY VERBAL LEARNING TEST
NEUROTROPHIC FACTORS CHANGE	14 Weeks	BLOOD DRAW

Trial Locations

Locations (1)

Università degli Studi del Molise; 🇮🇹 Campobasso, Italy