Parkinson DiseaseNCT04194762
PARK-FIT. Treadmill vs Cycling in Parkinson´s Disease. Definition of the Most Effective Model in Gait Reeducation
A study testing Non pharmacological therapy in people with Parkinson Disease, run by Puerta de Hierro University Hospital at 1 site in Spain.
Trial summary
PARK-FIT Treadmill vs Cycling in Parkinson´s Disease Rehabilitation. Non-pharmacological Clinical Trial for the Definition of the Most Effective Model in Gait Reeducation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Non pharmacological therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSpain
- Study dates
- 9 Sep 2019to 1 Jul 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient is diagnosed with idiopathic Parkinson's disease according to criteria from the United Kingdom Parkinson's Disease Society Brain Bank (UK-PDSBB)
- H\&Y less than or equal to 2
- Stable drug treatment in the six weeks prior to the start of training and during the study.
- Signature of informed consent.
Who cannot join
- Diagnosis of other neuro-degenerative disease
- Cardiovascular disease or other systemic condition that contraindicates the moderate physical exercise
- Need for ambulation support
- Frequent freezing of gait events.
- Mni- Mental State Examination (MMSE) <26
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222
Sabela Novo Ponte, MD, sabela.novo@salud.madrid.org
About this study
Official title: Treadmill vs Cycling in Parkinson´s Disease Rehabilitation. Non-pharmacological, Randomized, Blind Rater, Clinical Trial for the Definition of the Most Effective Model in Gait Reeducation
PARK-FIT Treadmill vs Cycling in Parkinson´s Disease Rehabilitation. Non-pharmacological Clinical Trial for the Definition of the Most Effective Model in Gait Reeducation.
Read the detailed description
Treadmill vs Cycling in Parkinson´s Disease Rehabilitation. Non-pharmacological Clinical Trial for the Definition of the Most Effective Model in Gait Reeducation.
- Conditions
- Parkinson Disease
- Being tested
- Non pharmacological therapy
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non pharmacological therapyOther
treadmill training and cycling training in equal intensity exercise.
| Study group | Role | What they receive |
|---|---|---|
| treadmill training | Experimental | Three training sessions per week for two months of treadmill. The intensity of exercise is monitored through the heart rate (HR). Patients ought to maintain a HR between 40 and 50% of the reserve HR Receives: Other: Non pharmacological therapy |
| Cycling | Active comparator | Three training sessions per week for two months of cycling. The intensity of exercise is monitored through the heart rate (HR). Patients ought to maintain a HR between 40 and 50% of the reserve HR Receives: Other: Non pharmacological therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in step length after treadmill training or cycling.
Highlight changes in the length of the step after training in treadmill or cycling in patients with Parkinson´s disease.
Measured: Ten months
Changes in step length after treadmill training. Discussion of its specificity to Parkinson´s disease
A description of step length and cadence for different velocities of gait after treadmill training.
Measured: Ten months
Secondary outcomes (1)
Rating Scale for Gait Evaluation in Parkinson's disease ( RSGE- PD scale )
Gait status through the RSGE-PD Scale before and after the intervention.
Measured: Ten months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start9 Sep 2019
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Parallel groups
- Model description
- non pharmacological, randomised, double arm intervention. Treadmill training vs cycling training in equal intensity of exercise conditions.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Puerta de Hierro University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabela Novo Ponte, Puerta de Hierro University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04194762
- Sponsor's protocol ID
- P.I.: 154/18
- Status last verified
- Dec 2019
- First submitted
- 13 Oct 2019
- Last updated
- 11 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 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. 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 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treadmill vs Cycling in Parkinson´s Disease Rehabilitation. Non-pharmacological, Randomized, Blind Rater, Clinical Trial for the Definition of the Most Effective Model in Gait Reeducation
- ClinicalTrials.gov ID
- NCT04194762
- Acronym / sponsor ID
- P.I.: 154/18
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Puerta de Hierro University HospitalUniversity, hospital or other
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 11 Dec 2019 (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.
PARK-FIT Treadmill vs Cycling in Parkinson´s Disease Rehabilitation. Non-pharmacological Clinical Trial for the Definition of the Most Effective Model in Gait Reeducation.
Detailed description
Treadmill vs Cycling in Parkinson´s Disease Rehabilitation. Non-pharmacological Clinical Trial for the Definition of the Most Effective Model in Gait Reeducation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- non pharmacological, randomised, double arm intervention. Treadmill training vs cycling training in equal intensity of exercise conditions.
| Arm | Type | Receives |
|---|---|---|
| treadmill training | Experimental | Other: Non pharmacological therapyThree training sessions per week for two months of treadmill. The intensity of exercise is monitored through the heart rate (HR). Patients ought to maintain a HR between 40 and 50% of the reserve HR |
| Cycling | Active comparator | Other: Non pharmacological therapyThree training sessions per week for two months of cycling. The intensity of exercise is monitored through the heart rate (HR). Patients ought to maintain a HR between 40 and 50% of the reserve HR |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is diagnosed with idiopathic Parkinson's disease according to criteria from the United Kingdom Parkinson's Disease Society Brain Bank (UK-PDSBB)
- H\&Y less than or equal to 2
- Stable drug treatment in the six weeks prior to the start of training and during the study.
- Signature of informed consent.
Key exclusion criteria (5 listed)
- Diagnosis of other neuro-degenerative disease
- Cardiovascular disease or other systemic condition that contraindicates the moderate physical exercise
- Need for ambulation support
- Frequent freezing of gait events.
- Mni- Mental State Examination (MMSE) <26
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 |
|---|---|---|
| Non pharmacological therapytreadmill training and cycling training in equal intensity exercise. | Other | Cycling, treadmill training |
Primary outcome
Changes in step length after treadmill training or cycling.
Time frame: Ten months
Highlight changes in the length of the step after training in treadmill or cycling in patients with Parkinson´s disease.
Changes in step length after treadmill training. Discussion of its specificity to Parkinson´s disease
Time frame: Ten months
A description of step length and cadence for different velocities of gait after treadmill training.
1 secondary outcome
Rating Scale for Gait Evaluation in Parkinson's disease ( RSGE- PD scale )
Time frame: Ten months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2019.
- 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 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: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non pharmacological therapy in people with Parkinson Disease, run by Puerta de Hierro University Hospital at 1 site in Spain.
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 4 inclusion and 5 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 Dec 2019. 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 Spain. 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?
Contact Sabela Novo, MD (+34 911 91 60 00, sabela.novo@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in step length after treadmill training or cycling. (time frame: Ten months). The study lists 2 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 NCT04194762, which also lists 2 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 Dec 2019.