NCT05565300

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2022

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 4, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

May 24, 2024

Status Verified

May 1, 2024

Enrollment Period

1.2 years

First QC Date

September 29, 2022

Last Update Submit

May 23, 2024

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (4)

  • Timed Up and Go

    Dynamic balance

    Change from Baseline Timed Up and Go at 12 weeks

  • Sit to Stand test

    Lower limbs strength

    Change from Baseline Sit to Stand Test at 12 weeks

  • Movement Disorder Society - Unified Parkinson's Disease Rating Scale

    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

    Quality of life

    Change from Baseline Parkinson's Disease Questionnaire - 39 at 12 weeks (0-100, better lower values)

Secondary Outcomes (2)

  • Trail Making Test A & B

    Change from Baseline Trail Making Test A & B at 12 weeks

  • Stroop test

    Change from Baseline Stroop Test at 12 weeks

Study Arms (2)

Cycling combined with cognitive tasks

EXPERIMENTAL
Other: Cycling exerciseOther: Cognitive tasks

Cycling

ACTIVE COMPARATOR
Other: Cycling exercise

Interventions

Cycling exerciseOTHER

30 minutes of cycling (90 rpm).

CyclingCycling combined with cognitive tasks
Cognitive tasksOTHER

30 minutes of cognitive tasks based on the different domains of the Mini Mental Scale.

Cycling combined with cognitive tasks

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Parkinson disease
  • Hoehn and Yahr 1 and 2

You may not qualify if:

  • Hoehn and Yahr \>2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Vigo

Pontevedra, 36005, Spain

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 29, 2022

First Posted

October 4, 2022

Study Start

September 15, 2022

Primary Completion

December 15, 2023

Study Completion

December 15, 2023

Last Updated

May 24, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)