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Effect of WB-EMS on Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Strenght training combined with WB-EMS
Cardiovascular training with WB-EMS
Control group
Sponsored by
Università degli studi di Roma Foro Italico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Università degli Studi del Molise

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

"Strength training + WB-EMS"

Cardiovascular training + WB-EMS

Control group

Arm Description

Strength training combined with WB-EMS : 2 times/week for 20 minutes

Cardiovascular training, using rowing machine, combined with WB-EMS : 2 times/week for 20 minutes

No physical activity

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 21, 2021
Last Updated
May 10, 2023
Sponsor
Università degli studi di Roma Foro Italico
Collaborators
Giuseppe Calcagno, Giovanni Fiorilli, Andrea Buonsenso, Marco Centorbi
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1. Study Identification

Unique Protocol Identification Number
NCT04878679
Brief Title
Effect of WB-EMS on Parkinson's Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 15, 2021 (Actual)
Primary Completion Date
September 23, 2022 (Actual)
Study Completion Date
April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università degli studi di Roma Foro Italico
Collaborators
Giuseppe Calcagno, Giovanni Fiorilli, Andrea Buonsenso, Marco Centorbi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
"Strength training + WB-EMS"
Arm Type
Experimental
Arm Description
Strength training combined with WB-EMS : 2 times/week for 20 minutes
Arm Title
Cardiovascular training + WB-EMS
Arm Type
Experimental
Arm Description
Cardiovascular training, using rowing machine, combined with WB-EMS : 2 times/week for 20 minutes
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
No physical activity
Intervention Type
Other
Intervention Name(s)
Strenght training combined with WB-EMS
Intervention Description
Bodyweight exercise training combined with WB-EMS (2 times/week) with a 85Hz electrical impulse
Intervention Type
Other
Intervention Name(s)
Cardiovascular training with WB-EMS
Intervention Description
Cardiovascular training , using the rowing machine, combined with WB-EMS (2 times/week) with a 7Hz electrical impulse
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
No physical activity
Primary Outcome Measure Information:
Title
REPETITIONS NUMBER CHANGE
Description
30S ARM CURL TEST
Time Frame
14 Weeks
Title
REPETITIONS NUMBER CHANGE
Description
30S SIT TO STAND TEST;
Time Frame
14 Weeks
Title
TIME(S) CHANGE
Description
SODA POP TEST ;
Time Frame
14 Weeks
Title
TIME(S) CHANGE
Description
8 FEET UP AND GO TEST ;
Time Frame
14 Weeks
Title
DISTANCE (M) CHANGE
Description
6 MINUTE WALKING TEST
Time Frame
14 Weeks
Title
UPPER LIMB STRENGHT CHANGE
Description
HAND GRIP TEST
Time Frame
14 Weeks
Title
LOWER BODY FLEXIBILITY
Description
CHAIR SIT AND REACH TEST
Time Frame
14 Weeks
Title
BALANCE AND STABILITY TEST CHANGE
Description
TINETTI BALANCE AND GAIT EVALUATION TEST
Time Frame
14 Weeks
Title
NUMBER OF ERRORS CHANGE
Description
STROOP TEST;
Time Frame
14 Weeks
Title
NUMBER OF ERRORS CHANGE
Description
REY AUDITORY VERBAL LEARNING TEST
Time Frame
14 Weeks
Title
TIME(S) CHANGE
Description
STROOP TEST
Time Frame
14 Weeks
Title
TIME(S) CHANGE
Description
TRAIL MAKING TEST CHANGE
Time Frame
14 Weeks
Title
NEUROTROPHIC FACTORS CHANGE
Description
BLOOD DRAW
Time Frame
14 Weeks
Title
ALPHA-SYNUCLEIN CHANGE
Description
BLOOD DRAW
Time Frame
14 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessandra di Cagno
Organizational Affiliation
Università degli studi di Roma Foro Italico
Official's Role
Principal Investigator
Facility Information:
Facility Name
Università degli Studi del Molise
City
Campobasso
ZIP/Postal Code
86100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effect of WB-EMS on Parkinson's Disease

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