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

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04194762
• Other study ID #: P.I.: 154/18
• Status: Recruiting
• Phase: N/A
• Start date: September 9, 2019
• Est. completion date: July 1, 2020

Study information

• Verified date: December 2019
• Source: Puerta de Hierro University Hospital
• Contact: Sabela Novo, MD
• Phone: +34 911 91 60 00
• Email: sabela.novo[@]salud.madrid.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: July 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• Non pharmacological therapy
treadmill training and cycling training in equal intensity exercise.

Locations

Country	Name	City	State
Spain	Hospital Universitario Puerta de Hierro	Majadahonda	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Puerta de Hierro University Hospital

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Movement Disorders Society- Unified Parkinson´s Disease Rating Scale II. (MDS-UPDRS II)	Motor functional status through the MDS-UPDRS II Scale before and after the intervention.	Ten months
Other	MDS-UPDRS III	Motor examination status through the MDS UPDRS III Scale before and after the intervention	Ten months
Other	The 39-item Parkinson´s Disease Questionnaire (PDQ-39)	Quality of life through the PDQ 39 Scale before and after the intervention.,	Ten months
Primary	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
Primary	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
Secondary	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