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

Primary Purpose

Parkinson, Parkinson Disease, Neurologic Disorder

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Exercise in water
Sponsored by
Pardis Specialized Wellness Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Parkinson focused on measuring Parkinson Disease, Aqua Therapy, Balance, Neurological Disorders

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pardis specialized wellness institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise group

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Rate of changes of Balance
Balance will be assessed by Berg Balance Scale test
Rate of changes of Flexibility
Balance will be assessed by Sit & Reach test
Rate of changes of Muscle Strength
Balance will be assessed by 30 s Sit to Stand test and Arm Curl test
Rate of changes of Gait Speed
Balance will be assessed by 4-meters gait speed test

Secondary Outcome Measures

Full Information

First Posted
February 10, 2023
Last Updated
February 22, 2023
Sponsor
Pardis Specialized Wellness Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05737992
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 10, 2022 (Actual)
Primary Completion Date
June 27, 2022 (Actual)
Study Completion Date
July 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pardis Specialized Wellness Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson, Parkinson Disease, Neurologic Disorder
Keywords
Parkinson Disease, Aqua Therapy, Balance, Neurological Disorders

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly allocate to intervention group or control group and will be examined in the same way
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The patients will continue their usual medication and their usual physical activity.
Intervention Type
Other
Intervention Name(s)
Exercise in water
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of changes of Balance
Description
Balance will be assessed by Berg Balance Scale test
Time Frame
Pre test and posttest (after 8 weeks)
Title
Rate of changes of Flexibility
Description
Balance will be assessed by Sit & Reach test
Time Frame
Pre test and posttest (after 8 weeks)
Title
Rate of changes of Muscle Strength
Description
Balance will be assessed by 30 s Sit to Stand test and Arm Curl test
Time Frame
Pre test and posttest (after 8 weeks)
Title
Rate of changes of Gait Speed
Description
Balance will be assessed by 4-meters gait speed test
Time Frame
Pre test and posttest (after 8 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MohammadAli Tabibi
Organizational Affiliation
Head of Department
Official's Role
Study Director
Facility Information:
Facility Name
Pardis specialized wellness institute
City
Isfahan
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in the published article, after deidentification are to be shared.
IPD Sharing Time Frame
The data will be available after the paper is published. No end date.
IPD Sharing Access Criteria
Data will be accessible with no criteria. Anyone who wishes will have access to data.
Citations:
PubMed Identifier
30931029
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.
Results Reference
result
PubMed Identifier
11673599
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.
Results Reference
result
PubMed Identifier
25217820
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.
Results Reference
result
PubMed Identifier
30487731
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.
Results Reference
result
PubMed Identifier
29568518
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.
Results Reference
result

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

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