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

Primary Purpose

Parkinson Disease

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Non pharmacological therapy
Sponsored by
Puerta de Hierro University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universitario Puerta de HierroRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

treadmill training

Cycling

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Rating Scale for Gait Evaluation in Parkinson's disease ( RSGE- PD scale )
Gait status through the RSGE-PD Scale before and after the intervention.

Full Information

First Posted
October 13, 2019
Last Updated
December 10, 2019
Sponsor
Puerta de Hierro University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04194762
Brief Title
PARK-FIT. Treadmill vs Cycling in Parkinson´s Disease. Definition of the Most Effective Model in Gait Reeducation
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 9, 2019 (Actual)
Primary Completion Date
June 1, 2020 (Anticipated)
Study Completion Date
July 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Puerta de Hierro University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
non pharmacological, randomised, double arm intervention. Treadmill training vs cycling training in equal intensity of exercise conditions.
Masking
InvestigatorOutcomes Assessor
Masking Description
Intervention arm for each patient is masked for the raters
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treadmill training
Arm Type
Experimental
Arm Description
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
Arm Title
Cycling
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Non pharmacological therapy
Intervention Description
treadmill training and cycling training in equal intensity exercise.
Primary Outcome Measure Information:
Title
Changes in step length after treadmill training or cycling.
Description
Highlight changes in the length of the step after training in treadmill or cycling in patients with Parkinson´s disease.
Time Frame
Ten months
Title
Changes in step length after treadmill training. Discussion of its specificity to Parkinson´s disease
Description
A description of step length and cadence for different velocities of gait after treadmill training.
Time Frame
Ten months
Secondary Outcome Measure Information:
Title
Rating Scale for Gait Evaluation in Parkinson's disease ( RSGE- PD scale )
Description
Gait status through the RSGE-PD Scale before and after the intervention.
Time Frame
Ten months
Other Pre-specified Outcome Measures:
Title
Movement Disorders Society- Unified Parkinson´s Disease Rating Scale II. (MDS-UPDRS II)
Description
Motor functional status through the MDS-UPDRS II Scale before and after the intervention.
Time Frame
Ten months
Title
MDS-UPDRS III
Description
Motor examination status through the MDS UPDRS III Scale before and after the intervention
Time Frame
Ten months
Title
The 39-item Parkinson´s Disease Questionnaire (PDQ-39)
Description
Quality of life through the PDQ 39 Scale before and after the intervention.,
Time Frame
Ten months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sabela Novo, MD
Phone
+34 911 91 60 00
Email
sabela.novo@salud.madrid.org
Facility Information:
Facility Name
Hospital Universitario Puerta de Hierro
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabela Novo Ponte, MD
Email
sabela.novo@salud.madrid.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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