Clinical trial NCT04878679: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Università degli studi di Roma Foro Italico
Sponsor class: OTHER
Collaborators: name: Giuseppe Calcagno
name: Giovanni Fiorilli
name: Andrea Buonsenso
name: Marco Centorbi
First posted: 2021-05-07
Enrollment: 36
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: REPETITIONS NUMBER CHANGE
timeFrame: 14 Weeks
measure: REPETITIONS NUMBER CHANGE
timeFrame: 14 Weeks
measure: TIME(S) CHANGE
timeFrame: 14 Weeks
measure: TIME(S) CHANGE
timeFrame: 14 Weeks
measure: DISTANCE (M) CHANGE
timeFrame: 14 Weeks
measure: UPPER LIMB STRENGHT CHANGE
timeFrame: 14 Weeks
measure: LOWER BODY FLEXIBILITY
timeFrame: 14 Weeks
measure: BALANCE AND STABILITY TEST CHANGE
timeFrame: 14 Weeks
measure: NUMBER OF ERRORS CHANGE
timeFrame: 14 Weeks
measure: NUMBER OF ERRORS CHANGE
timeFrame: 14 Weeks
measure: TIME(S) CHANGE
timeFrame: 14 Weeks
measure: TIME(S) CHANGE
timeFrame: 14 Weeks
measure: NEUROTROPHIC FACTORS CHANGE
timeFrame: 14 Weeks
measure: ALPHA-SYNUCLEIN CHANGE
timeFrame: 14 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Campobasso
country: Italy
facility: Università degli Studi del Molise
Study officials:
affiliation: Università degli studi di Roma Foro Italico
name: Alessandra di Cagno
role: PRINCIPAL_INVESTIGATOR
References: