Parkinson DiseaseICEBERGNCT06472843
Tailoring Upper Limb Exercise Advice for People With Parkinson Disease
An observational study of Parkinson Disease and Upper Limb, run by University of British Columbia.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Parkinson Disease, Upper Limb, Aerobic Exercise
- What is being tested?
- Exercise Intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with Parkinson Disease that are medically fit to perform a brief session of aerobic exercise.
Who may be able to join
- Adults over 19 with a clinical diagnosis of PD.
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Parkinson Disease, Upper Limb, Aerobic Exercise
- Being tested
- Exercise Intervention
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise InterventionBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Exercise Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
9-hole pegboard test
Time to complete the 9-hole pegboard test with the clinically more affected hand.
Measured: Through study completion, an average of 9 months
Secondary outcomes (5)
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
Measured: 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
Measured: Through study completion, an average of 9 months
Perceived exertion
Borg Category Ratio (CR)10 rating of perceived exertion (RPE) scale
Measured: Through study completion, an average of 9 months
Positive Affect
Self-reported positive-activated affect (PAA) two-dimensional likert scale
Measured: Through study completion, an average of 9 months
Enjoyment
Exercise Enjoyment (Likert scale)
Measured: Through study completion, an average of 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daryl Wile, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06472843
- Sponsor's protocol ID
- 001
- Acronym
- ICEBERG
- Status last verified
- Jun 2024
- First submitted
- 23 Apr 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailoring Upper Limb Exercise Advice for People With Parkinson Disease
- ClinicalTrials.gov ID
- NCT06472843
- Acronym / sponsor ID
- ICEBERG / 001
- Conditions
- Parkinson Disease, Upper Limb, Aerobic Exercise
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interval | – | Behavioral: Exercise InterventionParticipants 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 | – | Behavioral: Exercise InterventionParticipants 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with Parkinson Disease that are medically fit to perform a brief session of aerobic exercise.
Key inclusion criteria (1 listed)
- Adults over 19 with a clinical diagnosis of PD.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise InterventionThe 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). | Behavioural | Interval, Steady State |
Primary outcome
9-hole pegboard test
Time frame: Through study completion, an average of 9 months
Time to complete the 9-hole pegboard test with the clinically more affected hand.
5 secondary outcomes
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS III) score
Time frame: Through study completion, an average of 9 months
Finger tapping speed
Time frame: Through study completion, an average of 9 months
Perceived exertion
Time frame: Through study completion, an average of 9 months
Positive Affect
Time frame: Through study completion, an average of 9 months
Enjoyment
Time frame: Through study completion, an average of 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Upper Limb, run by University of British Columbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
9-hole pegboard test (time frame: Through study completion, an average of 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2024.