Effect of WB-EMS on Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04878679
• Other study ID #: ForoItalico1
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 15, 2021
• Est. completion date: April 30, 2023

Study information

• Verified date: May 2023
• Source: Università degli studi di Roma Foro Italico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 36
• Est. completion date: April 30, 2023
• Est. primary completion date: September 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• Strenght training combined with WB-EMS
Bodyweight exercise training combined with WB-EMS (2 times/week) with a 85Hz electrical impulse
• Cardiovascular training with WB-EMS
Cardiovascular training , using the rowing machine, combined with WB-EMS (2 times/week) with a 7Hz electrical impulse
• Control group
No physical activity

Locations

Country	Name	City	State
Italy	Università degli Studi del Molise	Campobasso

Sponsors (5)

Lead Sponsor	Collaborator
Università degli studi di Roma Foro Italico	Andrea Buonsenso, Giovanni Fiorilli, Giuseppe Calcagno, Marco Centorbi

Country where clinical trial is conducted

Italy, 

Outcome

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