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

Sponsor
Pardis Specialized Wellness Institute (Other)
Overall Status
Completed
CT.gov ID
NCT05737992
Collaborator
(none)
42
1
2
2.8
14.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Exercise in water
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants will be randomly allocate to intervention group or control group and will be examined in the same wayParticipants will be randomly allocate to intervention group or control group and will be examined in the same way
Masking:
Single (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.
Primary Purpose:
Supportive Care
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
Actual Study Start Date :
Apr 10, 2022
Actual Primary Completion Date :
Jun 27, 2022
Actual Study Completion Date :
Jul 5, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Rate of changes of Balance [Pre test and posttest (after 8 weeks)]

    Balance will be assessed by Berg Balance Scale test

  2. Rate of changes of Flexibility [Pre test and posttest (after 8 weeks)]

    Balance will be assessed by Sit & Reach test

  3. Rate of changes of Muscle Strength [Pre test and posttest (after 8 weeks)]

    Balance will be assessed by 30 s Sit to Stand test and Arm Curl test

  4. Rate of changes of Gait Speed [Pre test and posttest (after 8 weeks)]

    Balance will be assessed by 4-meters gait speed test

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pardis specialized wellness institute Isfahan Iran, Islamic Republic of

Sponsors and Collaborators

  • Pardis Specialized Wellness Institute

Investigators

  • Study Director: MohammadAli Tabibi, Head of Department

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pardis Specialized Wellness Institute
ClinicalTrials.gov Identifier:
NCT05737992
Other Study ID Numbers:
  • PA21PD-2-02
First Posted:
Feb 21, 2023
Last Update Posted:
Feb 24, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Pardis Specialized Wellness Institute
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 24, 2023