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

M

Majadahonda Iron Gate University

Status

Unknown

Conditions

Parkinson Disease

Treatments

Other: Non pharmacological therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04194762
P.I.: 154/18

Details and patient eligibility

About

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.

Full description

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

Enrollment

48 estimated patients

Sex

All

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

48 participants in 2 patient groups

treadmill training
Experimental group
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
Treatment:
Other: Non pharmacological therapy
Cycling
Active Comparator group
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
Treatment:
Other: Non pharmacological therapy

Trial contacts and locations

1

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Central trial contact

Sabela Novo, MD

Data sourced from clinicaltrials.gov

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