Effect of WB-EMS on Parkinson's Disease

May 10, 2023 updated by: Alessandra di Cagno, Università degli studi di Roma Foro Italico

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Campobasso, Italy, 86100
        • Università degli studi del molise

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli studi di Roma Foro Italico

Collaborators

Giuseppe Calcagno
Giovanni Fiorilli
Andrea Buonsenso
Marco Centorbi

Investigators

  • Principal Investigator: Alessandra di Cagno, Università degli studi di Roma Foro Italico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2021

Primary Completion (Actual)

September 23, 2022

Study Completion (Anticipated)

April 30, 2023

Study Registration Dates

First Submitted

April 21, 2021

First Submitted That Met QC Criteria

May 5, 2021

First Posted (Actual)

May 7, 2021

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 10, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ForoItalico1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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