Tailoring Upper Limb Exercise Advice for People With Parkinson Disease (ICEBERG)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Parkinson Disease; Upper Limb; Aerobic Exercise
• Intervention / Treatment: Behavioral: Exercise Intervention

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 Type: Observational
• Enrollment (Estimated): 20

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• Adults over 19 with a clinical diagnosis of PD.

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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).
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; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of British Columbia

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: April 23, 2024
• First Submitted That Met QC Criteria: June 18, 2024
• First Posted (Actual): June 25, 2024

Study Record Updates

• Last Update Posted (Actual): June 25, 2024
• Last Update Submitted That Met QC Criteria: June 18, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 001 (Buy Pharma Ecza Deposu San. Tic. Ltd.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No