PARK-FIT. Treadmill vs Cycling in Parkinson´s Disease. Definition of the Most Effective Model in Gait Reeducation

Study Overview
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Brief Summary
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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
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Treadmill vs Cycling in Parkinson´s Disease Rehabilitation. Non-pharmacological Clinical Trial for the Definition of the Most Effective Model in Gait Reeducation.

Official Title
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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

Conditions
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Parkinson Disease

Intervention / Treatment
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* Other: Non pharmacological therapy


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: non pharmacological, randomised, double arm intervention. Treadmill training vs cycling training in equal intensity of exercise conditions.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treadmill training<br>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 | Other: Non pharmacological therapy<br>* treadmill training and cycling training in equal intensity exercise.<br>|
| Active Comparator: Cycling<br>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 | Other: Non pharmacological therapy<br>* treadmill training and cycling training in equal intensity exercise.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Ten months | 
| 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. | Ten months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rating Scale for Gait Evaluation in Parkinson's disease ( RSGE- PD scale ) | Gait status through the RSGE-PD Scale before and after the intervention. | Ten months |