Parkinson DiseaseNCT02547506
Comparison of Cardiorespiratory Fitness Among Regular Exercisers With and Without Parkinson Disease and Across Different Modes of Group Exercise
An observational study of Parkinson Disease, run by University of Indianapolis at 1 site in United States.
Trial summary
The central goal of the proposed study is to generate essential pilot data necessary to support an established line of research leading to future extramural grant submissions. The aims of the current study are two-fold: 1) to compare cardiorespiratory fitness (CRF) and gait endurance across three groups of people: (1)… Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Jun 2017
- 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 55 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 45 individuals will be enrolled in this cross-sectional study. Three groups will each consist of 15 individuals (individuals with Parkinson Disease that participate in boxing, individuals with Parkinson disease that participate in group exercise other than boxing, and individuals without disability that participate in group exercise other than boxing).
Who may be able to join
- All participants included in this study must be between the ages of 55 and 75
- Be able to ambulate independently without physical assistance, assistive device, or lower extremity orthosis
- Be able to follow at least 3-step verbal commands
- Participate in a community-based group exercise program
- Be classified as regular exercisers by participating in 120 minutes per week for at least 3 months
- And have a physician's consent to undergo a graded exercise test (GXT).
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- Furthermore, only participants that are identified as low or moderate risk for cardiovascular disease based on ACSM's risk stratification guidelines will be included in the study.
- Participants for the two PD groups must have a diagnosis of idiopathic PD
- Have a Hoehn-Yahr score of 1, 2, or 3
- And either participate regularly in boxing training at Rock Steady Boxing or participate in another community-based group exercise program on a regular basis, classified as 120 minutes per week for at least 3 months.
Who cannot join
- Participants may not be included in the study if they have had any surgery in the past 6 months
- Current musculoskeletal or complications from other health issues that influence walking.
- The participants without disability cannot be involved in the study if they have any preexisting neurological conditions.
- Participants with PD cannot be involved in the study if they have preexisting neurological conditions other than idiopathic PD (e.g. no diagnosis of Parkinson Plus syndrome), past brain surgery or implantation of a deep brain stimulator.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Indianapolis
Indianapolis, Indiana, 46227
About this study
The central goal of the proposed study is to generate essential pilot data necessary to support an established line of research leading to future extramural grant submissions. The aims of the current study are two-fold: 1) to compare cardiorespiratory fitness (CRF) and gait endurance across three groups of people: (1) individuals with Parkinson Disease (PD) who participate in boxing on a regular basis, (2) individuals with PD who participate in exercise other than boxing on a regular basis and (3) healthy controls of the same age who exercise on a regular basis and 2) to examine the relationship between CRF and motor symptoms of PD (bradykinesia, tremor and postural instability). Forty-five participants (15 for each group) who participate in exercise on a regular basis (at least 120 minutes of exercise per week for the past 3 months) will be recruited for this cross-sectional study. In a single testing session, participants will perform the following tests: (1) clinical performance measures and (2) a CRF assessment. A one-way ANOVA with appropriate post hoc tests will be used to examine differences in dependent variables across the three exercise groups. Relationships between CRF and clinical performance measures will be evaluated with Pearson's correlation coefficients.
- Conditions
- Parkinson Disease
- Keywords
- cardiorespiratory fitness, group exercise
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson Disease (Boxing) | Individuals with Parkinson Disease who participate in boxing on a regular basis | |
| Parkinson Disease (Group Exercise) | Individuals with Parkinson Disease who participate in group exercise other than boxing on a regular basis | |
| Healthy Controls | Individuals without disability who participate in group exercise other than boxing on a regular basis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory Fitness
Aerobic capacity determined via VO2max protocol
Measured: 1 day
Secondary outcomes (3)
Six Minute Walk Test
Gait endurance will be determined by having participants walk as far as they can on a pre-determined, fixed distance course of 30 meters one way, in six minutes, resting if needed.
Measured: 1 day
Unified Parkinson's Disease Rating Scale
The MDS-UPDRS is a revision of the original UPDRS, and is a used to assess impairments related to PD. The inventory consists of multiple questions self-assessing an individual's activities of daily living (ADLs), as well as, an assessed examination of the motor symptoms associated with PD.
Measured: 1 day
StepWatch Activity Monitor
Home and community stepping activity will be assessed using a StepWatch Activity Monitor (SAM) worn by the patient.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionJun 2017
- Study completionJun 2017
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.
- 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Indianapolis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie Miller, University of Indianapolis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02547506
- Sponsor's protocol ID
- 0726
- Status last verified
- Oct 2019
- First submitted
- 9 Sep 2015
- Last updated
- 9 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cardiorespiratory Fitness Among Regular Exercisers With and Without Parkinson Disease and Across Different Modes of Group Exercise
- ClinicalTrials.gov ID
- NCT02547506
- Acronym / sponsor ID
- 0726
- Conditions
- Parkinson Disease
- Keywords
- cardiorespiratory fitness, group exercise
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of IndianapolisUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 11 Sep 2015 (estimated)
- 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 central goal of the proposed study is to generate essential pilot data necessary to support an established line of research leading to future extramural grant submissions. The aims of the current study are two-fold: 1) to compare cardiorespiratory fitness (CRF) and gait endurance across three groups of people: (1) individuals with Parkinson Disease (PD) who participate in boxing on a regular basis, (2) individuals with PD who participate in exercise other than boxing on a regular basis and (3) healthy controls of the same age who exercise on a regular basis and 2) to examine the relationship between CRF and motor symptoms of PD (bradykinesia, tremor and postural instability). Forty-five participants (15 for each group) who participate in exercise on a regular basis (at least 120 minutes of exercise per week for the past 3 months) will be recruited for this cross-sectional study. In a single testing session, participants will perform the following tests: (1) clinical performance measures and (2) a CRF assessment. A one-way ANOVA with appropriate post hoc tests will be used to examine differences in dependent variables across the three exercise groups. Relationships between CRF and clinical performance measures will be evaluated with Pearson's correlation coefficients.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Parkinson Disease (Boxing) | – | –Individuals with Parkinson Disease who participate in boxing on a regular basis |
| Parkinson Disease (Group Exercise) | – | –Individuals with Parkinson Disease who participate in group exercise other than boxing on a regular basis |
| Healthy Controls | – | –Individuals without disability who participate in group exercise other than boxing on a regular basis |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 45 individuals will be enrolled in this cross-sectional study. Three groups will each consist of 15 individuals (individuals with Parkinson Disease that participate in boxing, individuals with Parkinson disease that participate in group exercise other than boxing, and individuals without disability that participate in group exercise other than boxing).
Key inclusion criteria (10 listed)
- All participants included in this study must be between the ages of 55 and 75
- Be able to ambulate independently without physical assistance, assistive device, or lower extremity orthosis
- Be able to follow at least 3-step verbal commands
- Participate in a community-based group exercise program
- Be classified as regular exercisers by participating in 120 minutes per week for at least 3 months
Key exclusion criteria (4 listed)
- Participants may not be included in the study if they have had any surgery in the past 6 months
- Current musculoskeletal or complications from other health issues that influence walking.
- The participants without disability cannot be involved in the study if they have any preexisting neurological conditions.
- Participants with PD cannot be involved in the study if they have preexisting neurological conditions other than idiopathic PD (e.g. no diagnosis of Parkinson Plus syndrome), past brain surgery or implantation of a deep brain stimulator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiorespiratory Fitness
Time frame: 1 day
Aerobic capacity determined via VO2max protocol
3 secondary outcomes
Six Minute Walk Test
Time frame: 1 day
Unified Parkinson's Disease Rating Scale
Time frame: 1 day
StepWatch Activity Monitor
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by University of Indianapolis at 1 site in United States.
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 10 inclusion and 4 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: finished, as of the sponsor's last update on 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cardiorespiratory Fitness (time frame: 1 day). 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 9 Oct 2019.