Effect of WB-EMS on Parkinson's Disease
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
1 other identifier
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable parkinson-disease
Started Apr 2021
Typical duration for not_applicable parkinson-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 15, 2021
CompletedFirst Submitted
Initial submission to the registry
April 21, 2021
CompletedFirst Posted
Study publicly available on registry
May 7, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 23, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2023
CompletedMay 11, 2023
May 1, 2023
1.4 years
April 21, 2021
May 10, 2023
Conditions
Outcome Measures
Primary Outcomes (14)
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
Study Arms (3)
"Strength training + WB-EMS"
EXPERIMENTALStrength training combined with WB-EMS : 2 times/week for 20 minutes
Cardiovascular training + WB-EMS
EXPERIMENTALCardiovascular training, using rowing machine, combined with WB-EMS : 2 times/week for 20 minutes
Control group
ACTIVE COMPARATORNo physical activity
Interventions
Bodyweight exercise training combined with WB-EMS (2 times/week) with a 85Hz electrical impulse
Cardiovascular training , using the rowing machine, combined with WB-EMS (2 times/week) with a 7Hz electrical impulse
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Università degli studi di Roma Foro Italicolead
- Giuseppe Calcagnocollaborator
- Giovanni Fiorillicollaborator
- Andrea Buonsensocollaborator
- Marco Centorbicollaborator
Study Sites (1)
Università degli Studi del Molise
Campobasso, 86100, Italy
Related Publications (3)
Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
PMID: 38588457DERIVEDdi Cagno A, Buonsenso A, Centorbi M, Manni L, Di Costanzo A, Casazza G, Parisi A, Guerra G, Calcagno G, Iuliano E, Soligo M, Fiorilli G; WB-EMS Parkinson's Group. Whole body-electromyostimulation effects on serum biomarkers, physical performances and fatigue in Parkinson's patients: A randomized controlled trial. Front Aging Neurosci. 2023 Feb 9;15:1086487. doi: 10.3389/fnagi.2023.1086487. eCollection 2023.
PMID: 36845654DERIVEDErnst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
PMID: 36602886DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alessandra di Cagno
Università degli studi di Roma Foro Italico
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Alessandra di Cagno
Study Record Dates
First Submitted
April 21, 2021
First Posted
May 7, 2021
Study Start
April 15, 2021
Primary Completion
September 23, 2022
Study Completion
April 30, 2023
Last Updated
May 11, 2023
Record last verified: 2023-05