Effects of Cycling Dual-task in Parkinson's Disease.

May 23, 2024 updated by: Iris Machado de Oliveira, University of Vigo

Effects of a Forced Cycling Program With Cognitive Stimulation on Symptomatology, Physical Condition, and Cognition in People Diagnosed With Parkinson's Disease.

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)

44

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, 36005
        • 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

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
30 minutes of cycling (90 rpm).
Other: Cognitive tasks
30 minutes of cognitive tasks based on the different domains of the Mini Mental Scale.
Active Comparator: Cycling
Other: Cycling exercise
30 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 12 weeks
Dynamic balance
Change from Baseline Timed Up and Go at 12 weeks
Sit to Stand test
Time Frame: Change from Baseline Sit to Stand Test at 12 weeks
Lower limbs strength
Change from Baseline Sit to Stand Test at 12 weeks
Movement Disorder Society - Unified Parkinson's Disease Rating Scale
Time Frame: Change from Baseline Unified Parkinson's Disease Rating Scale at 12 weeks (0-159, better lower values)
Parkinson's Disease rating
Change from Baseline Unified Parkinson's Disease Rating Scale at 12 weeks (0-159, better lower values)
Parkinson's Disease Questionnaire - 39
Time Frame: Change from Baseline Parkinson's Disease Questionnaire - 39 at 12 weeks (0-100, better lower values)
Quality of life
Change from Baseline Parkinson's Disease Questionnaire - 39 at 12 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 12 weeks
Attention, visual screening ability and processing speed
Change from Baseline Trail Making Test A & B at 12 weeks
Stroop test
Time Frame: Change from Baseline Stroop Test at 12 weeks
Ability to inhibit cognitive interference
Change from Baseline Stroop Test at 12 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)

September 15, 2022

Primary Completion (Actual)

December 15, 2023

Study Completion (Actual)

December 15, 2023

Study Registration Dates

First Submitted

September 29, 2022

First Submitted That Met QC Criteria

September 29, 2022

First Posted (Actual)

October 4, 2022

Study Record Updates

Last Update Posted (Actual)

May 24, 2024

Last Update Submitted That Met QC Criteria

May 23, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 205-2022-2/2nd

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.

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