Parkinson Disease
Conditions
Brief 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.
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.
Interventions
OTHERNon pharmacological therapy
treadmill training and cycling training in equal intensity exercise.
Sponsors
Puerta de Hierro University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Intervention arm for each patient is masked for the raters
Intervention model description
non pharmacological, randomised, double arm intervention. Treadmill training vs cycling training in equal intensity of exercise conditions.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in step length after treadmill training or cycling. | 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 | Ten months | A description of step length and cadence for different velocities of gait after treadmill training. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rating Scale for Gait Evaluation in Parkinson's disease ( RSGE- PD scale ) | Ten months | Gait status through the RSGE-PD Scale before and after the intervention. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Movement Disorders Society- Unified Parkinson´s Disease Rating Scale II. (MDS-UPDRS II) | Ten months | Motor functional status through the MDS-UPDRS II Scale before and after the intervention. |
| MDS-UPDRS III | Ten months | Motor examination status through the MDS UPDRS III Scale before and after the intervention |
| The 39-item Parkinson´s Disease Questionnaire (PDQ-39) | Ten months | Quality of life through the PDQ 39 Scale before and after the intervention., |
Countries
Spain
Contacts
Primary ContactSabela Novo, MD
Outcome results
None listed