The Effect of Exercise in Water on Functional Fitness in People With Parkinson's Disease

NCT ID: NCT05737992

Last Updated: 2023-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-10

Study Completion Date

2022-07-05

Brief Summary

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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

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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

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Parkinson Parkinson Disease Neurologic Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly allocate to intervention group or control group and will be examined in the same way
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
A research project collaborator who is not informed about grouping of participants will obtain outcome measurements of the functional tests. Outcome adjudicators and data analysts will be kept blinded to the allocation. Moreover, all investigators, staff, and participants will be kept masked to outcome measurements and trial results.

Study Groups

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Exercise group

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.

Group Type EXPERIMENTAL

Exercise in water

Intervention Type OTHER

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.

Control group

The patients will continue their usual medication and their usual physical activity.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pardis Specialized Wellness Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MohammadAli Tabibi

Role: STUDY_DIRECTOR

Head of Department

Locations

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Pardis specialized wellness institute

Isfahan, , Iran

Site Status

Countries

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Iran

References

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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.

Reference Type RESULT
PMID: 30931029 (View on PubMed)

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.

Reference Type RESULT
PMID: 11673599 (View on PubMed)

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.

Reference Type RESULT
PMID: 25217820 (View on PubMed)

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.

Reference Type RESULT
PMID: 30487731 (View on PubMed)

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.

Reference Type RESULT
PMID: 29568518 (View on PubMed)

Other Identifiers

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PA21PD-2-02

Identifier Type: -

Identifier Source: org_study_id

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