Parkinson Disease and HydrotherapyNCT04863118
Acute Effects of Strength Training and High Intensity Training on Functional and Biochemical Measurements of Individuals With Parkinson's Disease in Different Environments and Depths
A study testing Strength training in shallow water and dry land and High-intensity training in shallow and deep water in people with Parkinson Disease and Hydrotherapy, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
Trial summary
Introduction: Parkinson's disease (PD) is the second most common neurodegenerative disease in the elderly. Chronic and progressive, it includes loss of dopamine, a neurotransmitter involved in the regulation of movement. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease and Hydrotherapy
- What is being tested?
- Strength training in shallow water and dry land and High-intensity training in shallow and deep water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Nov 2021to 30 Apr 2024
- 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- GI (Individuals with Parkinson Disease):
- Individuals diagnosed with Parkinson's disease for at least 6 months;
- Age between 50 to 70 years;
- Classified on the Hoehn and Yahr scale from 1 to 3;
- Rigid-akinetic and/or tremor-dominant type;
- Individuals who have preserved their cognitive skills, assessed by means of the Mini Mental State Examination (MMSE) and who have a cut-off score of 23/24 (FOLSTEIN et al., 1975).
Show all 10Show fewer
- GC (Healthy individuals):
- Age between 50 to 70 years;
- Individuals who have preserved their cognitive skills (with the same cut-off score as the GI in the MMSE);
- Walk independently.
Who cannot join
- GI (Individuals with Parkinson Disease):
- Individuals who have other associated musculoskeletal and neurological disorders;
- Individuals with dementia installed;
- Individuals with pathologies and injuries associated with the skin that make it impossible to enter the aquatic environment;
- Individuals with hydrophobia.
- GC (Healthy individuals):
Show all 10Show fewer
- Individuals who have musculoskeletal and neurological pathologies;
- Individuals with dementia installed;
- Individuals with pathologies and injuries associated with the skin that make it impossible to enter the aquatic environment;
- Individuals with hydrophobia.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Fernanda Cechetti
Porto Alegre, Rio Grande do Sul, 90050-170
Fernanda Cechetti
About this study
Official title: Acute Effects of Strength Training in Shallow Water and Dry Land and High-intensity Training in Shallow and Deep Water, on Functional Measures and Biochemistries of Individuals With Parkinson's Disease
Introduction: Parkinson's disease (PD) is the second most common neurodegenerative disease in the elderly. Chronic and progressive, it includes loss of dopamine, a neurotransmitter involved in the regulation of movement. Thus, functional changes, such as postural disorders, trunk flexor pattern, muscle activation deficits, impairment of gait, balance, and mobility are common findings in this population. Once there is dopaminergic depletion, it is important to identify mechanisms that act in the production and survival of nigral dopaminergic neurons, like the brain-derived neurotrophic factor (BDNF). Studies describe a correlation between serum BDNF levels and PD motor dysfunction. Still, it is presumed that physical therapy can positively regulate substances that act directly on the Central Nervous System, such as BDNF. Physical exercise, in addition to promoting biochemical modulations in PD, can provide benefits in motor symptoms that sometimes do not improve with drugs. Conventional physiotherapy performed on dry land is a therapeutic resource used in PD. The conventional physiotherapy is useful for management of functional changes caused by PD due to muscle strengthening exercises. These exercises can be adapted and performed in water, at different depths, shallow and deep water. Thus, aquatic physiotherapy has been shown to be able to interfere in PD motor disorders, with perspective of maximizing the rehabilitation program effects due to the physical properties of water. These reasons, in addition to the large use of these interventions in the clinical practice and their likely benefits in the PD alterations, suggest the importance of studies in this area. Furthermore, the immediate effects of strengthening interventions with global extensor musculature emphasis on global extensor musculature, and of high-intensity training protocols, which encompass different environments and different depths, on functional and biochemical measures of PD are poorly studied.
Objectives: To verify the acute effects of a global extensor musculature strength training protocol, performed on dry land and shallow water, and of a high-intensity training protocol performed in shallow and deep water on functional and biochemical measurements of individuals with PD.
Methods: This will be a single-blind crossover, cross-sectional study with a 24-hour follow-up. The sample will be composed of subjects between 50 and 70 years old, classified from 1 to 3 in the Hoehn and Yahr scale, with a PD diagnosis rigid-akinetic and/or tremor-dominant type in the "OFF" period of the medication. In this research there will be an intervention group (IG) composed of individuals with Parkinson's disease and a control group (CG) of healthy individuals. Both will be randomly distributed in a randomized way and submitted to two different training sessions, for 60 minutes, at different times, in order to analyze the acute effects and follow-up of the following interventions: a strength training of the global extensor musculature in dry land and shallow water (120 cm deep) and high-intensity training (Borg Scale), at different depths: shallow water (120 cm deep) and deep water. To characterize the sample, anamnesis and Motor Examination of Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS III) will be performed. The individuals will be submitted to pre, post and 24h evaluations after the intervention. Functional measures will be analyzed: postural stability, by stabilometry; strength, by isokinetic dynamometry; spatiotemporal gait variables, with kinematic analysis; balance, with Berg Balance Scale and functional mobility with Timed Up and Go test and biochemical analysis: venous blood collection and ELISA test will be performed measuring serum BDNF levels. In this way, the acute effects of the global extensor musculature strength training protocol and of high-intensity training on the different variables analyzed, environments, depths and moments of evaluation will be analyzed and compared.
- Conditions
- Parkinson Disease and Hydrotherapy
- Being tested
- Strength training in shallow water and dry land, High-intensity training in shallow and deep water
- Keywords
- Parkinson's disease, Physiotherapy, Hydrotherapy, Gait, Posture
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength training in shallow water and dry landOther
Dry land: The intervention will last for 60 minutes, consisting of exercises to strengthen the global extensor musculature, that is, involving the upper limbs, trunk and lower limbs. Weights and equipment for strength training will be used. The sessions will start with 10 minutes of warm-up, the central part of exercises to strengthen the extensor muscles and the last part will consist of oriented stretches. In the central part, a typical strength training will be performed (2-6 series; 85% of RM), using submaximal subjective effort and with repetition control.
Shallow water: The intervention performed on dry land will be adapted and produced in an aquatic environment. Aquatic implements will be used for strength training.
High-intensity training in shallow and deep waterOther
Shallow water: The intervention will last 60 minutes. The exercises consist of: immersion, balance, strength, agility and displacement in the water. As they will start with 10 minutes of warm-up and the last part will consist of stretches oriented along the edge of the pool and on the depth reduction platform. In the main part of the intervention, different styles of exercises will be performed, with or without the use of implements. Displacements will have varying speeds in the same session, defined by Borg's Scale of subjective sensation of effort.
Deep water: The intervention carried out in shallow water will be adapted with the use of floating belts and reproduced in deep water.
| Study group | Role | What they receive |
|---|---|---|
| Strength training protocol performed in shallow water and dry land | Experimental | Parkinson Disease and healthy individuals Receives: Other: Strength training in shallow water and dry land |
| High-intensity training protocol performed in shallow and deep water | Experimental | Parkinson Disease and healthy individuals Receives: Other: High-intensity training in shallow and deep water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in postural stability (stabilometry)
Stabilometry will be used as a method of evaluating the postural balance of the analyzed subjects by quantifying their oscillations, thus, measurements of the levels of stability will be performed when standing in an upright position, with eyes open and closed. Data will be collected through the AMTI force platform - OR6-6 Force plate with MAS-6 amp. The patient will be positioned in an upright posture on the platform, as relaxed as possible, with barefoot and approximately shoulder width apart as described by Laufer; Ashkenazi and Josman (2008). The subject will be asked to look at a point fixed to a wall in front of him, at eye level. Three attempts will be made with an initial 20 seconds for adaptation that will be discarded followed by 25 seconds of valid collection.
Measured: Changes between pre and post immediate intervention. Changes 24 hours after interventions.
Secondary outcomes (6)
Strength (isokinetic dynamometry)
Isokinetic dynamometry aims to assess an individual's muscle condition, measuring their strength, power and endurance, determining the degree of muscle deficiency they present. The individuals will be submitted to an assessment of the isometric torque in flexion and maximum extension of upper limbs, trunk and lower limbs using the Cybex Norm isokinetic dynamometer (Cybex Inc., Ronkonkoma, NY, USA). For familiarization, there will be two submaximal isometric contractions in each position. The evaluation protocol consists of three maximum voluntary isometric contractions, lasting 5 seconds in each position. Participants will be verbally encouraged during contractions, with an interval of 2 minutes between each contraction, to avoid fatigue. An interval of 20 minutes will be made between the assessments of the flexion torque for the extension of the upper limbs, trunk and lower limbs. The contraction with the highest torque value will be applied for data analysis using the Humac software
Measured: Changes between pre and post immediate intervention. Changes 24 hours after interventions.
Spatiotemporal gait variables (kinematic analysis)
For the kinematic analysis, 22 reflective markers will be positioned on both sides of the body in order to use a modified full body model that the program uses. A treadmill will be used for the tests. 3D kinematic data will be collected from image records using a VICON kinematics system, which consists of six synchronized cameras that use a shooting frequency of 100 Hz. After system calibration and placement of markers, the acquisition phase where each participant will be guided and positioned on a force platform and instructed to maintain an orthostatic position with the feet aligned, during a period of 5 seconds for system calibration. Next, gait assessment will be carried out, where the subjects will have to walk independently, as usual, with barefoot, on a specific path on a 8m long and 1.4m wide walkway at a self-selected speed.
Measured: Changes between pre and post immediate intervention. Changes 24 hours after interventions.
Balance (Berg's Balance Scale - BBS)
The BBS will be used to assess the static, dynamic balance and the risk of falls of the analyzed subjects. This scale assesses the performance of functional balance with 14 tests, which are directed to the individual's ability to sit, stand, reach, rotate around himself, look over his shoulders, stand in one-leg support and take steps. It has a maximum score of 56 points and a minimum of 0 points, where 17 each test has five alternatives ranging from 0 to 4 points (MIYAMOTO et al., 2004).
Measured: Changes between pre and post immediate intervention. Changes 24 hours after interventions.
Functional mobility (Timed Up and Go test - TUG)
To assess functional mobility, the TUG will be performed, in which the subject starts sitting in a chair, walks for a distance of 3 meters, goes around a cone, returns and sits down on the chair again. The subject is oriented to perform the test as soon as possible. Free individuals and have less than 10 seconds, since they have reasonable balance and gait speed, while dependents have 30 seconds or more.
Measured: Changes between pre and post immediate intervention. Changes 24 hours after interventions.
Biochemical analysis of the serum BDNF level (venous blood collection)
The biochemical measurements of the serum BDNF level will be analyzed by means of blood collection and ELISA test, blood samples (approximately 5 mL) will be collected between 7:00 am and 9:00 am, in the pre, post and 24h evaluation after the last session. The tubes will be centrifuged at 1048g for 10 min. Serum BDNF levels will be determined by the immunoenzymatic assay method (ELISA), with a specific kit (Promega, USA). All samples will be measured in duplicate by a SpectraMax M2e microplate reader (Molecular Devices, USA).
Measured: Changes between pre and post immediate intervention. Changes 24 hours after interventions.
Biochemical analysis of the serum cortisol level (venous blood collection)
The biochemical measurements of the serum BDNF level will be analyzed by means of blood collection and ELISA test, blood samples (approximately 5 mL) will be collected between 7:00 am and 9:00 am, in the pre, post and 24h evaluation after the last session. The tubes will be centrifuged at 1048g for 10 min. Serum cortisol levels will be measured by Enzyme Immunoassay (EIA) according to the manufacturer's instructions (Accubind, USA). All samples will be measured in duplicate by a SpectraMax M2e microplate reader (Molecular Devices, USA).
Measured: Changes between pre and post immediate intervention. Changes 24 hours after interventions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start1 Nov 2021
- Primary completion20 Nov 2023
- Study completion30 Apr 2024 (estimated)
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 Disease and HydrotherapyStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernanda Cechetti, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04863118
- Sponsor's protocol ID
- DPEAQ21
- Status last verified
- Feb 2024
- First submitted
- 11 Apr 2021
- Last updated
- 12 Feb 2024
- 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 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Strength Training in Shallow Water and Dry Land and High-intensity Training in Shallow and Deep Water, on Functional Measures and Biochemistries of Individuals With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04863118
- Acronym / sponsor ID
- DPEAQ21
- Conditions
- Parkinson Disease and Hydrotherapy
- Keywords
- Parkinson's disease, Physiotherapy, Hydrotherapy, Gait, Posture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 28 Apr 2021 (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.
Introduction: Parkinson's disease (PD) is the second most common neurodegenerative disease in the elderly. Chronic and progressive, it includes loss of dopamine, a neurotransmitter involved in the regulation of movement. Thus, functional changes, such as postural disorders, trunk flexor pattern, muscle activation deficits, impairment of gait, balance, and mobility are common findings in this population. Once there is dopaminergic depletion, it is important to identify mechanisms that act in the production and survival of nigral dopaminergic neurons, like the brain-derived neurotrophic factor (BDNF). Studies describe a correlation between serum BDNF levels and PD motor dysfunction. Still, it is presumed that physical therapy can positively regulate substances that act directly on the Central Nervous System, such as BDNF. Physical exercise, in addition to promoting biochemical modulations in PD, can provide benefits in motor symptoms that sometimes do not improve with drugs. Conventional physiotherapy performed on dry land is a therapeutic resource used in PD. The conventional physiotherapy is useful for management of functional changes caused by PD due to muscle strengthening exercises. These exercises can be adapted and performed in water, at different depths, shallow and deep water. Thus, aquatic physiotherapy has been shown to be able to interfere in PD motor disorders, with perspective of maximizing the rehabilitation program effects due to the physical properties of water. These reasons, in addition to the large use of these interventions in the clinical practice and their likely benefits in the PD alterations, suggest the importance of studies in this area. Furthermore, the immediate effects of strengthening interventions with global extensor musculature emphasis on global extensor musculature, and of high-intensity training protocols, which encompass different environments and different depths, on functional and biochemical measures of PD are poorly studied.
Objectives: To verify the acute effects of a global extensor musculature strength training protocol, performed on dry land and shallow water, and of a high-intensity training protocol performed in shallow and deep water on functional and biochemical measurements of individuals with PD.
Methods: This will be a single-blind crossover, cross-sectional study with a 24-hour follow-up. The sample will be composed of subjects between 50 and 70 years old, classified from 1 to 3 in the Hoehn and Yahr scale, with a PD diagnosis rigid-akinetic and/or tremor-dominant type in the "OFF" period of the medication. In this research there will be an intervention group (IG) composed of individuals with Parkinson's disease and a control group (CG) of healthy individuals. Both will be randomly distributed in a randomized way and submitted to two different training sessions, for 60 minutes, at different times, in order to analyze the acute effects and follow-up of the following interventions: a strength training of the global extensor musculature in dry land and shallow water (120 cm deep) and high-intensity training (Borg Scale), at different depths: shallow water (120 cm deep) and deep water. To characterize the sample, anamnesis and Motor Examination of Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS III) will be performed. The individuals will be submitted to pre, post and 24h evaluations after the intervention. Functional measures will be analyzed: postural stability, by stabilometry; strength, by isokinetic dynamometry; spatiotemporal gait variables, with kinematic analysis; balance, with Berg Balance Scale and functional mobility with Timed Up and Go test and biochemical analysis: venous blood collection and ELISA test will be performed measuring serum BDNF levels. In this way, the acute effects of the global extensor musculature strength training protocol and of high-intensity training on the different variables analyzed, environments, depths and moments of evaluation will be analyzed and compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strength training protocol performed in shallow water and dry land | Experimental | Other: Strength training in shallow water and dry landParkinson Disease and healthy individuals |
| High-intensity training protocol performed in shallow and deep water | Experimental | Other: High-intensity training in shallow and deep waterParkinson Disease and healthy individuals |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Individuals diagnosed with Parkinson's disease for at least 6 months;
- Age between 50 to 70 years;
- Classified on the Hoehn and Yahr scale from 1 to 3;
- Rigid-akinetic and/or tremor-dominant type;
- Individuals who have preserved their cognitive skills, assessed by means of the Mini Mental State Examination (MMSE) and who have a cut-off score of 23/24 (FOLSTEIN et al., 1975).
Key exclusion criteria (10 listed)
- Individuals who have other associated musculoskeletal and neurological disorders;
- Individuals with dementia installed;
- Individuals with pathologies and injuries associated with the skin that make it impossible to enter the aquatic environment;
- Individuals with hydrophobia.
- Individuals who have musculoskeletal and neurological pathologies;
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 |
|---|---|---|
| Strength training in shallow water and dry landDry land: The intervention will last for 60 minutes, consisting of exercises to strengthen the global extensor musculature, that is, involving the upper limbs, trunk and lower limbs. Weights and equipment for strength training will be used. The sessions will start with 10 minutes of warm-up, the central part of exercises to strengthen the extensor muscles and the last part will consist of oriented stretches. In the central part, a typical strength training will be performed (2-6 series; 85% of RM), using submaximal subjective effort and with repetition control. Shallow water: The intervention performed on dry land will be adapted and produced in an aquatic environment. Aquatic implements will be used for strength training. | Other | Strength training protocol performed in shallow water and dry land |
| High-intensity training in shallow and deep waterShallow water: The intervention will last 60 minutes. The exercises consist of: immersion, balance, strength, agility and displacement in the water. As they will start with 10 minutes of warm-up and the last part will consist of stretches oriented along the edge of the pool and on the depth reduction platform. In the main part of the intervention, different styles of exercises will be performed, with or without the use of implements. Displacements will have varying speeds in the same session, defined by Borg's Scale of subjective sensation of effort. Deep water: The intervention carried out in shallow water will be adapted with the use of floating belts and reproduced in deep water. | Other | High-intensity training protocol performed in shallow and deep water |
Primary outcome
Changes in postural stability (stabilometry)
Time frame: Changes between pre and post immediate intervention. Changes 24 hours after interventions.
Stabilometry will be used as a method of evaluating the postural balance of the analyzed subjects by quantifying their oscillations, thus, measurements of the levels of stability will be performed when standing in an upright position, with eyes open and closed. Data will be collected through the AMTI force platform - OR6-6 Force plate with MAS-6 amp. The patient will be positioned in an upright posture on the platform, as relaxed as possible, with barefoot and approximately shoulder width apart as described by Laufer; Ashkenazi and Josman (2008). The subject will be asked to look at a point fixed to a wall in front of him, at eye level. Three attempts will be made with an initial 20 seconds for adaptation that will be discarded followed by 25 seconds of valid collection.
6 secondary outcomes
Strength (isokinetic dynamometry)
Time frame: Changes between pre and post immediate intervention. Changes 24 hours after interventions.
Spatiotemporal gait variables (kinematic analysis)
Time frame: Changes between pre and post immediate intervention. Changes 24 hours after interventions.
Balance (Berg's Balance Scale - BBS)
Time frame: Changes between pre and post immediate intervention. Changes 24 hours after interventions.
Functional mobility (Timed Up and Go test - TUG)
Time frame: Changes between pre and post immediate intervention. Changes 24 hours after interventions.
Biochemical analysis of the serum BDNF level (venous blood collection)
Time frame: Changes between pre and post immediate intervention. Changes 24 hours after interventions.
Biochemical analysis of the serum cortisol level (venous blood collection)
Time frame: Changes between pre and post immediate intervention. Changes 24 hours after interventions.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength training in shallow water and dry land and High-intensity training in shallow and deep water in people with Parkinson Disease and Hydrotherapy, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
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 10 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 12 Feb 2024. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact UFCSPA FUHSPortoAlegre ((51)3303-8804, cep@ufcspa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in postural stability (stabilometry) (time frame: Changes between pre and post immediate intervention. Changes 24 hours after interventions.). 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 NCT04863118, 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 12 Feb 2024.