Cycling Dual-task in Parkinson's Disease

May 17, 2022 updated by: Iris Machado de Oliveira, University of Vigo

Effects of a Cycling Dual-task Intervention on Cognition and Functionality in Parkinson's Disease: a Pilot Randomized Clinical Trial

Taking into account the process of functional and cognitive evolution that patients with Parkinson's disease experience throughout the evolution of the pathology, the objective of this study is to evaluate the effect of a dual-task program combining cognitive tasks and forced cycling on the functional and cognitive capacity of these patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Pontevedra, Spain, 36004
        • University of Vigo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Parkinson disease
  • Hoehn and Yahr 1 and 2

Exclusion Criteria:

  • Hoehn and Yahr >2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cycling combined with cognitive tasks
Other: Cycling exercise
20 minutes of cycling (90 rpm).
Other: Cognitive tasks
20 minutes of cognitive tasks based on the different domains of the UPDRS scale.
Active Comparator: Cycling
Other: Cycling exercise
20 minutes of cycling (90 rpm).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed Up and Go
Time Frame: Change from Baseline Timed Up and Go at 7 weeks
Dynamic balance
Change from Baseline Timed Up and Go at 7 weeks
Sit to Stand test
Time Frame: Change from Baseline Sit to Stan Test at 7 weeks
Lower limbs strength
Change from Baseline Sit to Stan Test at 7 weeks
Movement Disorder Society - Unified Parkinson's Disease Rating Scale
Time Frame: Change from Baseline Unified Parkinson's Disease Rating Scale at 7 weeks (0-159, better lower values)
Parkinson's Disease rating
Change from Baseline Unified Parkinson's Disease Rating Scale at 7 weeks (0-159, better lower values)
Parkinson's Disease Questionnaire - 39
Time Frame: Change from Baseline Parkinson's Disease Questionnaire - 39 at 7 weeks (0-100, better lower values)
Quality of life
Change from Baseline Parkinson's Disease Questionnaire - 39 at 7 weeks (0-100, better lower values)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trail Making Test A & B
Time Frame: Change from Baseline Trail Making Test A & B at 7 weeks
Attention, visual screening ability and processing speed
Change from Baseline Trail Making Test A & B at 7 weeks
Stroop test
Time Frame: Change from Baseline Stroop Test at 7 weeks
Ability to inhibit cognitive interference
Change from Baseline Stroop Test at 7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Vigo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2021

Primary Completion (Actual)

October 28, 2021

Study Completion (Actual)

January 31, 2022

Study Registration Dates

First Submitted

November 26, 2021

First Submitted That Met QC Criteria

January 7, 2022

First Posted (Actual)

January 11, 2022

Study Record Updates

Last Update Posted (Actual)

May 25, 2022

Last Update Submitted That Met QC Criteria

May 17, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020/057

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson Disease

Clinical Trials on Cycling exercise

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United States

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe