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

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

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.

Study Overview

• Status: Unknown
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: Non pharmacological therapy

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 Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Recruiting
      • Hospital Universitario Puerta De Hierro
      • Contact: Sabela Novo Ponte, MD; Email: sabela.novo@salud.madrid.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: treadmill training; 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; treadmill training and cycling training in equal intensity exercise.
ACTIVE_COMPARATOR: Cycling; 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; treadmill training and cycling training in equal intensity exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
MDS-UPDRS III	Motor examination status through the MDS UPDRS III Scale before and after the intervention	Ten months
The 39-item Parkinson´s Disease Questionnaire (PDQ-39)	Quality of life through the PDQ 39 Scale before and after the intervention.,	Ten months

Collaborators and Investigators

• Sponsor: Puerta de Hierro University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 9, 2019
• Primary Completion (ANTICIPATED): June 1, 2020
• Study Completion (ANTICIPATED): July 1, 2020

Study Registration Dates

• First Submitted: October 13, 2019
• First Submitted That Met QC Criteria: December 10, 2019
• First Posted (ACTUAL): December 11, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 11, 2019
• Last Update Submitted That Met QC Criteria: December 10, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: P.I.: 154/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No