Clinical trial NCT05737992: The Effect of Exercise in Water on Functional Fitness in People With Parkinson's Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson
Parkinson Disease
Neurologic Disorder
Keywords: Parkinson Disease
Aqua Therapy
Balance
Neurological Disorders
Lead sponsor: Pardis Specialized Wellness Institute
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 42
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly allocate to intervention group or control group and will be examined in the same way
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of changes of Balance
timeFrame: Pre test and posttest (after 8 weeks)
measure: Rate of changes of Flexibility
timeFrame: Pre test and posttest (after 8 weeks)
measure: Rate of changes of Muscle Strength
timeFrame: Pre test and posttest (after 8 weeks)
measure: Rate of changes of Gait Speed
timeFrame: Pre test and posttest (after 8 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Pardis specialized wellness institute
Study officials:
affiliation: Head of Department
name: MohammadAli Tabibi
role: STUDY_DIRECTOR
References:
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: 10.1016/j.hkpj.2016.03.002. eCollection 2016 Dec.
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.
citation: 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 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.
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.2018.00839. eCollection 2018.
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. eCollection 2018.