ParkinsonNCT05737992
The Effect of Exercise in Water on Functional Fitness in People With Parkinson's Disease
A study testing Exercise in water in people with Parkinson and Parkinson Disease, run by Pardis Specialized Wellness Institute at 1 site in Iran.
Trial summary
The goal of this clinical trial study is to learn about the effect of aquatic exercise in parkinson's patients. The main questions it aims to answer are: What is the effect of exercise in water on balance in parkinson's patients? What is the effect of exercise in water on muscle strength in parkinson's patients? What… Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Parkinson, Parkinson Disease, Neurologic Disorder
- What is being tested?
- Exercise in water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteIran
- Study dates
- 10 Apr 2022to 5 Jul 2022
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of idiopathic PD, from mild to moderate stages (severity from 1 to 4), according to the original version of the Hoehn \& Yahr scale (HY)17, assessed by the neurologist
- Having medical certificate for performing physical activities and attending heated pools
Who cannot join
- Having another neurological pathology
- Having limiting orthopedic or heart associated conditions
- changing physical activities or L-dopa-based drug intake parameters
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of of High Intensity Interval Training in Water on Functional Fitness in People With Parkinson's Disease: A Randomized Controlled Trial
The goal of this clinical trial study is to learn about the effect of aquatic exercise in parkinson's patients. The main questions it aims to answer are:
- What is the effect of exercise in water on balance in parkinson's patients?
- What is the effect of exercise in water on muscle strength in parkinson's patients?
- What is the effect of exercise in water on flexibility in parkinson's patients? Parkinson's patients in this study will do some functional tests. One group of them will do exercises in water 3 times weekly for 8 weeks.
Read the detailed description
Parkinson's disease (PD) is a progressive, neurodegenerative movement disorder characterised by the motor symptoms bradykinesia, tremor, rigidity, and postural instability. These are commonly associated with non-motor disturbances, neurobehavioural symptoms and reduced quality of life.
Exercise is currently recommended as an additional strategy to manage PD-induced disability and is a key component of rehabilitation programs for people with PD.
Aquatic exercise is another form of non-conventional exercise that has been growing in popularity in the context of neurorehabilitation.16 The aquatic setting offers specific mechanical advantages due to the hydrostatic and hydrodynamic principles of buoyancy, viscosity and drag.
Due to its ability to enhance functional mobility whilst also being enjoyable,aquatic exercise has become a very popular form of physical training in the management of neurodegenerative disorders.
Recent studies suggest that high-intensity interval training (HIIT) is promising for promoting neuroplasticity in human PD, with short training time and reduced burden. Biomarkers for neuroplasticity such as brain-derived neurotrophic factor (BDNF) and neurodegeneration (including neurofilament light chain ((NfL) and α-synuclein) may play a role, but their response to HIIT is not well-investigated.
The aims of this study are to investigate the effects of HIIT exercises in water on balance, muscle strength, flexibility and gait speed in PD patients.
- Conditions
- Parkinson, Parkinson Disease, Neurologic Disorder
- Being tested
- Exercise in water
- Keywords
- Parkinson Disease, Aqua Therapy, Balance, Neurological Disorders
- Medical subject headings
- Parkinson Disease, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise in waterOther
Participants will do some exercises in water for 30-60 minutes. Exercises will be performed at a moderate exercise intensity (12-14 on the Borg Rate of Perceived (RPE) Scale).
All protocols are tailor-made based on each individual's needs and physical abilities.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | Patients in the intervention group will do high intensity interval training (HIIT) in water. In this study, HIIT training will be short intervals (30 seconds) of movements and 15 seconds of rest.Exercises will be done in a floating position in the deep part. The intervention will be done 3 sessions weekly. The length will be 8 weeks. Receives: Other: Exercise in water |
| Control group | No intervention | The patients will continue their usual medication and their usual physical activity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of changes of Balance
Balance will be assessed by Berg Balance Scale test
Measured: Pre test and posttest (after 8 weeks)
Rate of changes of Flexibility
Balance will be assessed by Sit \& Reach test
Measured: Pre test and posttest (after 8 weeks)
Rate of changes of Muscle Strength
Balance will be assessed by 30 s Sit to Stand test and Arm Curl test
Measured: Pre test and posttest (after 8 weeks)
Rate of changes of Gait Speed
Balance will be assessed by 4-meters gait speed test
Measured: Pre test and posttest (after 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start10 Apr 2022
- Primary completion27 Jun 2022
- Study completion5 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ParkinsonStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly allocate to intervention group or control group and will be examined in the same way
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pardis Specialized Wellness Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MohammadAli Tabibi, Study director, Head of Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05737992
- Sponsor's protocol ID
- PA21PD-2-02
- Status last verified
- Feb 2023
- First submitted
- 10 Feb 2023
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the published article, after deidentification are to be shared.
Publications
Methajarunon P, Eitivipart C, Diver CJ, Foongchomcheay A. Systematic review of published studies on aquatic exercise for balance in patients with multiple sclerosis, Parkinson's disease, and hemiplegia. Hong Kong Physiother J. 2016 Jul 7;35:12-20. doi: 10.1016/j.hkpj.2016.03.002. eCollection 2016 Dec.
PubMed 30931029Hughes AJ, Daniel SE, Lees AJ. Improved accuracy of clinical diagnosis of Lewy body Parkinson's disease. Neurology. 2001 Oct 23;57(8):1497-9. doi: 10.1212/wnl.57.8.1497.
PubMed 11673599Cugusi L, Cadeddu C, Nocco S, Orru F, Bandino S, Deidda M, Caria A, Bassareo PP, Piras A, Cabras S, Mercuro G. Effects of an aquatic-based exercise program to improve cardiometabolic profile, quality of life, and physical activity levels in men with type 2 diabetes mellitus. PM R. 2015 Feb;7(2):141-8; quiz 148. doi: 10.1016/j.pmrj.2014.09.004. Epub 2014 Sep 10.
PubMed 25217820Jimenez-Maldonado A, Renteria I, Garcia-Suarez PC, Moncada-Jimenez J, Freire-Royes LF. The Impact of High-Intensity Interval Training on Brain Derived Neurotrophic Factor in Brain: A Mini-Review. Front Neurosci. 2018 Nov 14;12:839. doi: 10.3389/fnins.2018.00839. eCollection 2018.
PubMed 30487731Hirsch MA, van Wegen EEH, Newman MA, Heyn PC. Exercise-induced increase in brain-derived neurotrophic factor in human Parkinson's disease: a systematic review and meta-analysis. Transl Neurodegener. 2018 Mar 20;7:7. doi: 10.1186/s40035-018-0112-1. eCollection 2018.
PubMed 29568518
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of of High Intensity Interval Training in Water on Functional Fitness in People With Parkinson's Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05737992
- Acronym / sponsor ID
- PA21PD-2-02
- Conditions
- Parkinson, Parkinson Disease, Neurologic Disorder
- Keywords
- Parkinson Disease, Aqua Therapy, Balance, Neurological Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Pardis Specialized Wellness InstituteUniversity, hospital or other
- Study start
- 10 Apr 2022 (actual)
- Primary completion
- 27 Jun 2022 (actual)
- Study completion
- 5 Jul 2022 (actual)
- First posted
- 21 Feb 2023 (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 goal of this clinical trial study is to learn about the effect of aquatic exercise in parkinson's patients. The main questions it aims to answer are:
- What is the effect of exercise in water on balance in parkinson's patients?
- What is the effect of exercise in water on muscle strength in parkinson's patients?
- What is the effect of exercise in water on flexibility in parkinson's patients? Parkinson's patients in this study will do some functional tests. One group of them will do exercises in water 3 times weekly for 8 weeks.
Detailed description
Parkinson's disease (PD) is a progressive, neurodegenerative movement disorder characterised by the motor symptoms bradykinesia, tremor, rigidity, and postural instability. These are commonly associated with non-motor disturbances, neurobehavioural symptoms and reduced quality of life.
Exercise is currently recommended as an additional strategy to manage PD-induced disability and is a key component of rehabilitation programs for people with PD.
Aquatic exercise is another form of non-conventional exercise that has been growing in popularity in the context of neurorehabilitation.16 The aquatic setting offers specific mechanical advantages due to the hydrostatic and hydrodynamic principles of buoyancy, viscosity and drag.
Due to its ability to enhance functional mobility whilst also being enjoyable,aquatic exercise has become a very popular form of physical training in the management of neurodegenerative disorders.
Recent studies suggest that high-intensity interval training (HIIT) is promising for promoting neuroplasticity in human PD, with short training time and reduced burden. Biomarkers for neuroplasticity such as brain-derived neurotrophic factor (BDNF) and neurodegeneration (including neurofilament light chain ((NfL) and α-synuclein) may play a role, but their response to HIIT is not well-investigated.
The aims of this study are to investigate the effects of HIIT exercises in water on balance, muscle strength, flexibility and gait speed in PD patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly allocate to intervention group or control group and will be examined in the same way
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: Exercise in waterPatients in the intervention group will do high intensity interval training (HIIT) in water. In this study, HIIT training will be short intervals (30 seconds) of movements and 15 seconds of rest.Exercises will be done in a floating position in the deep part. The intervention will be done 3 sessions weekly. The length will be 8 weeks. |
| Control group | No intervention | –The patients will continue their usual medication and their usual physical activity. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- clinical diagnosis of idiopathic PD, from mild to moderate stages (severity from 1 to 4), according to the original version of the Hoehn \& Yahr scale (HY)17, assessed by the neurologist
- Having medical certificate for performing physical activities and attending heated pools
Key exclusion criteria (3 listed)
- Having another neurological pathology
- Having limiting orthopedic or heart associated conditions
- changing physical activities or L-dopa-based drug intake parameters
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 in waterParticipants will do some exercises in water for 30-60 minutes. Exercises will be performed at a moderate exercise intensity (12-14 on the Borg Rate of Perceived (RPE) Scale). All protocols are tailor-made based on each individual's needs and physical abilities. | Other | Exercise group |
Primary outcome
Rate of changes of Balance
Time frame: Pre test and posttest (after 8 weeks)
Balance will be assessed by Berg Balance Scale test
Rate of changes of Flexibility
Time frame: Pre test and posttest (after 8 weeks)
Balance will be assessed by Sit \& Reach test
Rate of changes of Muscle Strength
Time frame: Pre test and posttest (after 8 weeks)
Balance will be assessed by 30 s Sit to Stand test and Arm Curl test
Rate of changes of Gait Speed
Time frame: Pre test and posttest (after 8 weeks)
Balance will be assessed by 4-meters gait speed test
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 24 Feb 2023.
- Results publication: PubMed 30931029Methajarunon P, Eitivipart C, Diver CJ, Foongchomcheay A. Systematic review of published studies on aquatic exercise for balance in patients with multiple sclerosis, Parkinson's disease, and hemiplegia. Hong Kong Physiother J. 2016 Jul 7;35:12-20. doi: 10.1016/j.hkpj.2016.03.002. eCollection 2016 Dec.
- Results publication: PubMed 11673599Hughes AJ, Daniel SE, Lees AJ. Improved accuracy of clinical diagnosis of Lewy body Parkinson's disease. Neurology. 2001 Oct 23;57(8):1497-9. doi: 10.1212/wnl.57.8.1497.
- Results publication: PubMed 25217820Cugusi L, Cadeddu C, Nocco S, Orru F, Bandino S, Deidda M, Caria A, Bassareo PP, Piras A, Cabras S, Mercuro G. Effects of an aquatic-based exercise program to improve cardiometabolic profile, quality of life, and physical activity levels in men with type 2 diabetes mellitus. PM R. 2015 Feb;7(2):141-8; quiz 148. doi: 10.1016/j.pmrj.2014.09.004. Epub 2014 Sep 10.
- Results publication: PubMed 30487731Jimenez-Maldonado A, Renteria I, Garcia-Suarez PC, Moncada-Jimenez J, Freire-Royes LF. The Impact of High-Intensity Interval Training on Brain Derived Neurotrophic Factor in Brain: A Mini-Review. Front Neurosci. 2018 Nov 14;12:839. doi: 10.3389/fnins.2018.00839. eCollection 2018.
- Results publication: PubMed 29568518Hirsch MA, van Wegen EEH, Newman MA, Heyn PC. Exercise-induced increase in brain-derived neurotrophic factor in human Parkinson's disease: a systematic review and meta-analysis. Transl Neurodegener. 2018 Mar 20;7:7. doi: 10.1186/s40035-018-0112-1. eCollection 2018.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the published article, after deidentification are to be shared.
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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.
MohammadAli Tabibi study director
Head of Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in water in people with Parkinson and Parkinson Disease, run by Pardis Specialized Wellness Institute at 1 site in Iran.
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 2 inclusion and 3 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 24 Feb 2023. 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 Iran. 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?
Rate of changes of Balance (time frame: Pre test and posttest (after 8 weeks)). The study lists 4 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 NCT05737992, which also lists 5 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 24 Feb 2023.