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

Not Applicable

• Conditions: Parkinson Disease
• Interventions: Other: Non pharmacological therapy

• Registration Number: NCT04194762
• Lead Sponsor: Puerta de Hierro University Hospital

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.

Study Timeline

• Study Start: 2019-09-09
• Study First Submitted: 2019-10-13
• Status Verified: 2019-12
• Study First Submitted QC: 2019-12-10
• Last Update Submitted: 2019-12-10
• Study First Posted: 2019-12-11
• Last Update Posted: 2019-12-11
• Primary Completion: 2020-06-01
• Study Completion: 2020-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treadmill training	Non pharmacological therapy	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
Cycling	Non pharmacological therapy	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hospital Universitario Puerta de Hierro; 🇪🇸 Majadahonda, Madrid, Spain