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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05737992
Other study ID # PA21PD-2-02
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 10, 2022
Est. completion date July 5, 2022

Study information

Verified date February 2023
Source Pardis Specialized Wellness Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date July 5, 2022
Est. primary completion date June 27, 2022
Accepts healthy volunteers No
Gender All
Age group 45 Years to 80 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Having another neurological pathology - Having limiting orthopedic or heart associated conditions - changing physical activities or L-dopa-based drug intake parameters

Study Design


Intervention

Other:
Exercise in water
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.

Locations

Country Name City State
Iran, Islamic Republic of Pardis specialized wellness institute Isfahan

Sponsors (1)

Lead Sponsor Collaborator
Pardis Specialized Wellness Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (5)

Cugusi 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 — View Citation

Hirsch 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. eCollec — View Citation

Hughes 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. — View Citation

Jimenez-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 — View Citation

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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of changes of Balance Balance will be assessed by Berg Balance Scale test Pre test and posttest (after 8 weeks)
Primary Rate of changes of Flexibility Balance will be assessed by Sit & Reach test Pre test and posttest (after 8 weeks)
Primary Rate of changes of Muscle Strength Balance will be assessed by 30 s Sit to Stand test and Arm Curl test Pre test and posttest (after 8 weeks)
Primary Rate of changes of Gait Speed Balance will be assessed by 4-meters gait speed test Pre test and posttest (after 8 weeks)
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