Tailoring Upper Limb Exercise Advice for People With Parkinson Disease

Not yet recruiting

• Conditions: Upper Limb; Parkinson Disease; Aerobic Exercise
• Interventions: Behavioral: Exercise Intervention

• Registration Number: NCT06472843
• Lead Sponsor: University of British Columbia

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.

Detailed Description

The purpose of this study is to examine the effects of hand cycling, an upper limb aerobic exercise, on hand function in individuals with Parkinson's Disease (PD).

Parkinson's Disease affects motor skills, including hand dexterity, which can impede daily activities. While aerobic exercise is known to have benefits for people with PD, the specific impact of upper limb exercises like hand cycling on hand function is less studied. Previous research suggests aerobic exercises can improve symptoms and motor function in PD. This study aims to fill the gap in understanding how hand cycling affects hand dexterity in PD. There is no placebo involved in this study as it compares two active intervention types: steady-state and high-intensity interval hand cycling.

This is a block randomized parallel group clinical trial involving a single session of exercise intervention. Participants will be randomly assigned to one of two groups: steady-state or high-intensity interval hand cycling. The study includes baseline assessments, the exercise intervention, and post-intervention assessments to evaluate changes in hand function.

The primary endpoint is the time to complete the 9-hole pegboard test with the clinically more affected hand. Secondary endpoints include changes in motor examination scores, finger tapping speed, and subjective measures of exercise perception. Analysis of covariance will be used to compare the primary outcome between groups, accounting for baseline performance and clinical characteristics. The planned sample size is 20 people with PD, aiming to capture varied clinical expressions of the disease.

Study Timeline

• Study First Submitted: 2024-04-23
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-18
• Last Update Submitted: 2024-06-18
• Study First Posted: 2024-06-25
• Last Update Posted: 2024-06-25
• Study Start: 2024-07-01
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Adults over 19 with a clinical diagnosis of PD.

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Exclusion Criteria

• 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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Interval	Exercise Intervention	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.
Steady State	Exercise Intervention	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.

Primary Outcome Measures

Name	Time	Method
9-hole pegboard test	Through study completion, an average of 9 months	Time to complete the 9-hole pegboard test with the clinically more affected hand.

Secondary Outcome Measures

Name	Time	Method
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS III) score	Through study completion, an average of 9 months	Motor subscale of the movement disorders society revised unified Parkinson Disease Rating Scale
Positive Affect	Through study completion, an average of 9 months	Self-reported positive-activated affect (PAA) two-dimensional likert scale
Finger tapping speed	Through study completion, an average of 9 months	Number of alternate finger taps completed in a 30 second period in each hand
Enjoyment	Through study completion, an average of 9 months	Exercise Enjoyment (Likert scale)
Perceived exertion	Through study completion, an average of 9 months	Borg Category Ratio (CR)10 rating of perceived exertion (RPE) scale