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

• Sponsor: University of Vigo (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05565300
• Collaborator: (none)
• Enrollment: 44
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 8.5
• Patients Per Site Per Month: 5.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Other: Cycling exercise; Other: Cognitive tasks	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effects of a Forced Cycling Program With Cognitive Stimulation on Symptomatology, Physical Condition, and Cognition in People Diagnosed With Parkinson's Disease.
• Actual Study Start Date: Sep 15, 2022
• Anticipated Primary Completion Date: Apr 1, 2023
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

1. Timed Up and Go [Change from Baseline Timed Up and Go at 12 weeks]

   Dynamic balance

2. Sit to Stand test [Change from Baseline Sit to Stand Test at 12 weeks]

   Lower limbs strength

3. Movement Disorder Society - Unified Parkinson's Disease Rating Scale [Change from Baseline Unified Parkinson's Disease Rating Scale at 12 weeks (0-159, better lower values)]

   Parkinson's Disease rating

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

   Quality of life

Secondary Outcome Measures

1. Trail Making Test A & B [Change from Baseline Trail Making Test A & B at 12 weeks]

   Attention, visual screening ability and processing speed

2. Stroop test [Change from Baseline Stroop Test at 12 weeks]

   Ability to inhibit cognitive interference

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Parkinson disease

• Hoehn and Yahr 1 and 2

Exclusion Criteria:

• Hoehn and Yahr >2

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Vigo	Pontevedra		Spain	36005

Sponsors and Collaborators

• University of Vigo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Iris Machado de Oliveira, Principal Investigator, University of Vigo
• ClinicalTrials.gov Identifier: NCT05565300
• Other Study ID Numbers: 205-2022-2/2nd
• First Posted: Oct 4, 2022
• Last Update Posted: Oct 4, 2022
• Last Verified: Sep 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Parkinson Disease

Study Results

No Results Posted as of Oct 4, 2022