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

February 22, 2023 updated by: Pardis Specialized Wellness Institute

The Effect of of High Intensity Interval Training in Water on Functional Fitness in People With Parkinson's Disease: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
No Intervention: Control group
The patients will continue their usual medication and their usual physical activity.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pardis Specialized Wellness Institute

Investigators

  • Study Director: MohammadAli Tabibi, Head of Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2022

Primary Completion (Actual)

June 27, 2022

Study Completion (Actual)

July 5, 2022

Study Registration Dates

First Submitted

February 10, 2023

First Submitted That Met QC Criteria

February 10, 2023

First Posted (Actual)

February 21, 2023

Study Record Updates

Last Update Posted (Actual)

February 24, 2023

Last Update Submitted That Met QC Criteria

February 22, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PA21PD-2-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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