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

NCT04194762 | Unknown DMC

• 1 other identifier: P.I.: 154/18
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Rating Scale for Gait Evaluation in Parkinson's disease ( RSGE- PD scale )

  Ten months

Other Outcomes (3)

• Movement Disorders Society- Unified Parkinson´s Disease Rating Scale II. (MDS-UPDRS II)

  Ten months

• MDS-UPDRS III

  Ten months

• The 39-item Parkinson´s Disease Questionnaire (PDQ-39)

  Ten months

Study Arms (2)

treadmill training

EXPERIMENTAL

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

Cycling

ACTIVE COMPARATOR

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

Interventions

Non pharmacological therapy OTHER

treadmill training and cycling training in equal intensity exercise.

Cycling; treadmill training

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Puerta de Hierro University Hospital: lead

Study Sites (1)

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

RECRUITING

Related Publications (2)

• Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

  PMID: 38588457 DERIVED

• Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

  PMID: 36602886 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Sabela Novo, MD

CONTACT

+34 911 91 60 00; sabela.novo@salud.madrid.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Intervention arm for each patient is masked for the raters
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: non pharmacological, randomised, double arm intervention. Treadmill training vs cycling training in equal intensity of exercise conditions.

Study Record Dates

• First Submitted: October 13, 2019
• First Posted: December 11, 2019
• Study Start: September 9, 2019
• Primary Completion: June 1, 2020
• Study Completion: July 1, 2020
• Last Updated: December 11, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)