Parkinson DiseaseNCT04878679
Effect of WB-EMS on Parkinson's Disease
A study testing Strenght training combined with WB-EMS and Cardiovascular training with WB-EMS in people with Parkinson Disease, run by Università degli studi di Roma Foro Italico at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Strenght training combined with WB-EMS and Cardiovascular training with WB-EMS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- 15 Apr 2021to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Parkinson Disease
- Being tested
- Strenght training combined with WB-EMS, Cardiovascular training with WB-EMS, Control group
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strenght training combined with WB-EMSOther
Bodyweight exercise training combined with WB-EMS (2 times/week) with a 85Hz electrical impulse
Cardiovascular training with WB-EMSOther
Cardiovascular training , using the rowing machine, combined with WB-EMS (2 times/week) with a 7Hz electrical impulse
Control groupOther
No physical activity
| Study group | Role | What they receive |
|---|---|---|
| "Strength training + WB-EMS" | Experimental | Strength training combined with WB-EMS : 2 times/week for 20 minutes Receives: Other: Strenght training combined with WB-EMS |
| Cardiovascular training + WB-EMS | Experimental | Cardiovascular training, using rowing machine, combined with WB-EMS : 2 times/week for 20 minutes Receives: Other: Cardiovascular training with WB-EMS |
| Control group | Active comparator | No physical activity Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
REPETITIONS NUMBER CHANGE
30S ARM CURL TEST
Measured: 14 Weeks
REPETITIONS NUMBER CHANGE
30S SIT TO STAND TEST;
Measured: 14 Weeks
TIME(S) CHANGE
SODA POP TEST ;
Measured: 14 Weeks
TIME(S) CHANGE
8 FEET UP AND GO TEST ;
Measured: 14 Weeks
DISTANCE (M) CHANGE
6 MINUTE WALKING TEST
Measured: 14 Weeks
UPPER LIMB STRENGHT CHANGE
HAND GRIP TEST
Measured: 14 Weeks
LOWER BODY FLEXIBILITY
CHAIR SIT AND REACH TEST
Measured: 14 Weeks
BALANCE AND STABILITY TEST CHANGE
TINETTI BALANCE AND GAIT EVALUATION TEST
Measured: 14 Weeks
NUMBER OF ERRORS CHANGE
STROOP TEST;
Measured: 14 Weeks
NUMBER OF ERRORS CHANGE
REY AUDITORY VERBAL LEARNING TEST
Measured: 14 Weeks
TIME(S) CHANGE
STROOP TEST
Measured: 14 Weeks
TIME(S) CHANGE
TRAIL MAKING TEST CHANGE
Measured: 14 Weeks
NEUROTROPHIC FACTORS CHANGE
BLOOD DRAW
Measured: 14 Weeks
ALPHA-SYNUCLEIN CHANGE
BLOOD DRAW
Measured: 14 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start15 Apr 2021
- Primary completion23 Sep 2022
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli studi di Roma Foro Italico
- Sponsor type
- University, hospital or other
- Collaborators
- Giuseppe Calcagno, Giovanni Fiorilli, Andrea Buonsenso, Marco Centorbi
- Responsible party
- Principal investigator, Alessandra di Cagno, Università degli studi di Roma Foro Italico
- Investigators
- Alessandra di Cagno, Principal investigator, Università degli studi di Roma Foro Italico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04878679
- Sponsor's protocol ID
- ForoItalico1
- Status last verified
- May 2023
- First submitted
- 21 Apr 2021
- Last updated
- 11 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38588457di 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.
PubMed 36845654Ernst 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.
PubMed 36602886
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04878679
- Acronym / sponsor ID
- ForoItalico1
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Università degli studi di Roma Foro ItalicoUniversity, hospital or other
- Collaborators
- Giuseppe Calcagno, Giovanni Fiorilli, Andrea Buonsenso, Marco Centorbi
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 23 Sep 2022 (actual)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 7 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| "Strength training + WB-EMS" | Experimental | Other: Strenght training combined with WB-EMSStrength training combined with WB-EMS : 2 times/week for 20 minutes |
| Cardiovascular training + WB-EMS | Experimental | Other: Cardiovascular training with WB-EMSCardiovascular training, using rowing machine, combined with WB-EMS : 2 times/week for 20 minutes |
| Control group | Active comparator | Other: Control groupNo physical activity |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strenght training combined with WB-EMSBodyweight exercise training combined with WB-EMS (2 times/week) with a 85Hz electrical impulse | Other | "Strength training + WB-EMS" |
| Cardiovascular training with WB-EMSCardiovascular training , using the rowing machine, combined with WB-EMS (2 times/week) with a 7Hz electrical impulse | Other | Cardiovascular training + WB-EMS |
| Control groupNo physical activity | Other | Control group |
Primary outcome
REPETITIONS NUMBER CHANGE
Time frame: 14 Weeks
30S ARM CURL TEST
REPETITIONS NUMBER CHANGE
Time frame: 14 Weeks
30S SIT TO STAND TEST;
TIME(S) CHANGE
Time frame: 14 Weeks
SODA POP TEST ;
TIME(S) CHANGE
Time frame: 14 Weeks
8 FEET UP AND GO TEST ;
DISTANCE (M) CHANGE
Time frame: 14 Weeks
6 MINUTE WALKING TEST
UPPER LIMB STRENGHT CHANGE
Time frame: 14 Weeks
HAND GRIP TEST
LOWER BODY FLEXIBILITY
Time frame: 14 Weeks
CHAIR SIT AND REACH TEST
BALANCE AND STABILITY TEST CHANGE
Time frame: 14 Weeks
TINETTI BALANCE AND GAIT EVALUATION TEST
NUMBER OF ERRORS CHANGE
Time frame: 14 Weeks
STROOP TEST;
NUMBER OF ERRORS CHANGE
Time frame: 14 Weeks
REY AUDITORY VERBAL LEARNING TEST
TIME(S) CHANGE
Time frame: 14 Weeks
STROOP TEST
TIME(S) CHANGE
Time frame: 14 Weeks
TRAIL MAKING TEST CHANGE
NEUROTROPHIC FACTORS CHANGE
Time frame: 14 Weeks
BLOOD DRAW
ALPHA-SYNUCLEIN CHANGE
Time frame: 14 Weeks
BLOOD DRAW
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Derived from this study: PubMed 38588457Ernst 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.
- Derived from this study: PubMed 36845654di 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.
- Derived from this study: PubMed 36602886Ernst 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessandra di Cagno principal investigator
Università degli studi di Roma Foro Italico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strenght training combined with WB-EMS and Cardiovascular training with WB-EMS in people with Parkinson Disease, run by Università degli studi di Roma Foro Italico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
REPETITIONS NUMBER CHANGE (time frame: 14 Weeks). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04878679, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.