Parkinson DiseaseNCT04291027
Aquatic Group Exercise for People With Parkinson Disease
A study testing Land Based Exercise and Aquatic Exercise in people with Parkinson Disease, run by Ithaca College at 1 site in United States.
Trial summary
This study will investigate the impact of land based or aquatic based group exercise on the balance, walking, balance confidence, and quality of life of people with idiopathic Parkinson disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Land Based Exercise and Aquatic Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2020to 10 Mar 2020
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults over the age of 18 who have been diagnosed with idiopathic Parkinson disease.
- stable dose of levadopa medication for 30 days prior to study initiation
- able to walk 20 feet without physical assistance
- a referral from a physician to participate in physical therapy
Who cannot join
- individuals with:
- uncontrolled cardiovascular or pulmonary conditions
- deep vein thrombosis in the last 6 months
- the use of breathing tube or feeding tube
- those with an extreme fear of exercising in the water
- an active dermatological condition (including eczema, psoriasis, or open wound) -any other neurological condition other than Parkinson disease
- a musculoskeletal condition that would impact their ability to participate in the exercise group
- cognitive impairment (a score of less than 24/30 on the Mini Mental Status Examination)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Aquatic and Land-based Group Exercise for Individuals With Parkinson Disease
This study will investigate the impact of land based or aquatic based group exercise on the balance, walking, balance confidence, and quality of life of people with idiopathic Parkinson disease. Participants will be randomized to participate in a land based or aquatic based group exercise program 2 times per week for 12 weeks. Prior to and after participation, balance, walking, quality of life, and balance confidence will be measured by a blinded examiner.
- Conditions
- Parkinson Disease
- Being tested
- Land Based Exercise, Aquatic 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.
Land Based ExerciseOther
Group exercise intervention will be held 2 times per week for 12 weeks and will include balance training, strengthening, gait training, and cardiovascular training.
Aquatic ExerciseOther
Group exercise intervention will be held 2 times per week for 12 weeks and will include balance training, strengthening, gait training, and cardiovascular training.
| Study group | Role | What they receive |
|---|---|---|
| Aquatic Group Exercise | Experimental | Not described Receives: Other: Aquatic Exercise |
| Land Based Group Exercise | Active comparator | Not described Receives: Other: Land Based Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mini-BESTest Score
The Mini-BESTest examines postural control. A higher scores means less balance impairment.
Measured: Prior to intervention, after 12 week intervention
Change in Movement Disorder Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS): Part III
The Movement Disorders Society-Unified Parkinson Disease Rating Scale examines motor function for people with Parkinson disease. A higher score indicates higher motor impairment related to Parkinson disease.
Measured: Prior to intervention, after 12 week intervention
Change in Gait Speed
The 10 meter walk test will be examined at self selected and fast speeds to examine gait speed.
Measured: Prior to intervention, after 12 week intervention
Secondary outcomes (2)
Change in Parkinson Disease Questionnaire-39 (PDQ-39)
The Parkinson disease questionnaire-39 measures quality of life for people with Parkinson disease. A higher score means more quality of life limitations related to Parkinson disease.
Measured: Prior to intervention, after 12 week intervention
Change in Falls Efficacy Scale-International.
The Falls Efficacy Scale-International measures a person's balance confidence. A higher score is related to worse balance confidence.
Measured: Prior to intervention, after 12 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start28 Feb 2020
- Primary completion10 Mar 2020
- Study completion10 Mar 2020
Why it stopped: The study needed to be stopped due to the COVID-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ithaca College
- Sponsor type
- University, hospital or other
- Collaborators
- Parkinson's Foundation
- Responsible party
- Principal investigator, Sarah Fishel, Ithaca College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04291027
- Sponsor's protocol ID
- 711
- Status last verified
- Mar 2021
- First submitted
- 26 Feb 2020
- Last updated
- 5 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
PubMed 38588457Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
PubMed 36602886
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Aquatic and Land-based Group Exercise for Individuals With Parkinson Disease
- ClinicalTrials.gov ID
- NCT04291027
- Acronym / sponsor ID
- 711
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study needed to be stopped due to the COVID-19 pandemic.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Ithaca CollegeUniversity, hospital or other
- Collaborators
- Parkinson's Foundation
- Study start
- 28 Feb 2020 (actual)
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 10 Mar 2020 (actual)
- First posted
- 2 Mar 2020 (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.
This study will investigate the impact of land based or aquatic based group exercise on the balance, walking, balance confidence, and quality of life of people with idiopathic Parkinson disease. Participants will be randomized to participate in a land based or aquatic based group exercise program 2 times per week for 12 weeks. Prior to and after participation, balance, walking, quality of life, and balance confidence will be measured by a blinded examiner.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aquatic Group Exercise | Experimental | Other: Aquatic Exercise |
| Land Based Group Exercise | Active comparator | Other: Land Based Exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adults over the age of 18 who have been diagnosed with idiopathic Parkinson disease.
- stable dose of levadopa medication for 30 days prior to study initiation
- able to walk 20 feet without physical assistance
- a referral from a physician to participate in physical therapy
Key exclusion criteria (8 listed)
- uncontrolled cardiovascular or pulmonary conditions
- deep vein thrombosis in the last 6 months
- the use of breathing tube or feeding tube
- those with an extreme fear of exercising in the water
- an active dermatological condition (including eczema, psoriasis, or open wound) -any other neurological condition other than Parkinson disease
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 |
|---|---|---|
| Land Based ExerciseGroup exercise intervention will be held 2 times per week for 12 weeks and will include balance training, strengthening, gait training, and cardiovascular training. | Other | Land Based Group Exercise |
| Aquatic ExerciseGroup exercise intervention will be held 2 times per week for 12 weeks and will include balance training, strengthening, gait training, and cardiovascular training. | Other | Aquatic Group Exercise |
Primary outcome
Change in Mini-BESTest Score
Time frame: Prior to intervention, after 12 week intervention
The Mini-BESTest examines postural control. A higher scores means less balance impairment.
Change in Movement Disorder Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS): Part III
Time frame: Prior to intervention, after 12 week intervention
The Movement Disorders Society-Unified Parkinson Disease Rating Scale examines motor function for people with Parkinson disease. A higher score indicates higher motor impairment related to Parkinson disease.
Change in Gait Speed
Time frame: Prior to intervention, after 12 week intervention
The 10 meter walk test will be examined at self selected and fast speeds to examine gait speed.
2 secondary outcomes
Change in Parkinson Disease Questionnaire-39 (PDQ-39)
Time frame: Prior to intervention, after 12 week intervention
Change in Falls Efficacy Scale-International.
Time frame: Prior to intervention, after 12 week intervention
Results and safety
The study was stopped early (reason given: The study needed to be stopped due to the COVID-19 pandemic.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2021.
- Derived from this study: PubMed 38588457Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
- Derived from this study: PubMed 36602886Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Land Based Exercise and Aquatic Exercise in people with Parkinson Disease, run by Ithaca College 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 4 inclusion and 8 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: stopped early, as of the sponsor's last update on 5 Apr 2021. 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 was stopped early (reason given: The study needed to be stopped due to the COVID-19 pandemic.). 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?
Change in Mini-BESTest Score (time frame: Prior to intervention, after 12 week intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04291027, which also lists 2 linked publications.
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 5 Apr 2021.