NCT06472843

Brief Summary

The investigators will explore the impact of hand cycling, on hand function in people with Parkinson's Disease (PD). The study will compare the effects of two different hand cycling approaches-steady-state and interval efforts-on improving hand dexterity in people with PD. Conducted as a clinical trial, it aims to understand if a single session of hand cycling can temporarily enhance hand function and if the nature of the exercise influences the benefit.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 25, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

June 25, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

April 23, 2024

Last Update Submit

June 18, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 9-hole pegboard test

    Time to complete the 9-hole pegboard test with the clinically more affected hand.

    Through study completion, an average of 9 months

Secondary Outcomes (5)

  • Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS III) score

    Through study completion, an average of 9 months

  • Finger tapping speed

    Through study completion, an average of 9 months

  • Perceived exertion

    Through study completion, an average of 9 months

  • Positive Affect

    Through study completion, an average of 9 months

  • Enjoyment

    Through study completion, an average of 9 months

Study Arms (2)

Interval

Participants in the interval condition will begin with a gradual one minute warm up effort with a ramp in the resistance gradually increasing from 0 watts to 60% of their peak power output (Wpeak) over 1 minute. They will then perform five sets of high intensity intervals with rest between these efforts. The intervals will be at 100% Wpeak for 15 seconds followed by 60% Wpeak for 45 seconds. During the work intervals participants will be encouraged to apply the highest cadence they can produce for the 15 second interval and resume a freely chosen cadence in the rest periods. After five interval repetitions (5 minutes) they will gradually warm-down from 60% Wpeak to 0 watts over 1 minute.

Behavioral: Exercise Intervention

Steady State

Participants in the steady state condition will begin the intervention with a gradual one minute warm up effort with a ramp in the resistance gradually increasing from 0 watts to 70% of their Wpeak over 1 minute. They will then continue at this resistance level at a freely chosen cadence for 5 minutes, after which they will gradually warm-down to 0 watts over 1 minute.

Behavioral: Exercise Intervention

Interventions

The exercise session is a fitness test using a hand bike, and you will be randomly assigned to one of two exercise sessions. The fitness test and exercise sessions are short (less than 10 minutes).

IntervalSteady State

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with Parkinson Disease that are medically fit to perform a brief session of aerobic exercise.

You may qualify if:

  • Adults over 19 with a clinical diagnosis of PD.

You may not qualify if:

  • Medical contraindication to aerobic exercise, such as unstable cardiovascular disease, or physical disability that precludes arm exercise.
  • Individuals will be excluded if, upon screening with the Canadian Society for Exercise Physiology (CSEP) Get Active Questionnaire and International Physical Activity Questionnaire Short Form (IPAQ-SF) a need for further evaluation before exercise is identified

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor, University of British Columbia Southern Medical Program

Study Record Dates

First Submitted

April 23, 2024

First Posted

June 25, 2024

Study Start

July 1, 2024

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

June 25, 2024

Record last verified: 2024-06