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

NCT05737992 | Completed DMC

• 1 other identifier: PA21PD-2-02
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson; Parkinson Disease; Neurologic Disorder

Keywords

Parkinson Disease; Aqua Therapy; Balance; Neurological Disorders

Outcome Measures

Primary Outcomes (4)

• Rate of changes of Balance

  Balance will be assessed by Berg Balance Scale test

  Pre test and posttest (after 8 weeks)

• Rate of changes of Flexibility

  Balance will be assessed by Sit \& Reach test

  Pre test and posttest (after 8 weeks)

• Rate of changes of Muscle Strength

  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

  Balance will be assessed by 4-meters gait speed test

  Pre test and posttest (after 8 weeks)

Study Arms (2)

Exercise group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

Exercise in water 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.

Exercise group

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Having another neurological pathology
• Having limiting orthopedic or heart associated conditions
• changing physical activities or L-dopa-based drug intake parameters

Sponsors & Collaborators

• Pardis Specialized Wellness Institute: lead

Study Sites (1)

Pardis specialized wellness institute

Isfahan, Iran

Location

Related Publications (5)

• 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.

  PMID: 30931029 RESULT

• 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.

  PMID: 11673599 RESULT

• 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.

  PMID: 25217820 RESULT

• 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.

  PMID: 30487731 RESULT

• 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.

  PMID: 29568518 RESULT

MeSH Terms

Conditions

Parkinson Disease; Nervous System Diseases

Interventions

Exercise; Water

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• MohammadAli Tabibi

  Head of Department

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly allocate to intervention group or control group and will be examined in the same way

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: February 21, 2023
• Study Start: April 10, 2022
• Primary Completion: June 27, 2022
• Study Completion: July 5, 2022
• Last Updated: February 24, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will be available after the paper is published. No end date.
• Access Criteria: Data will be accessible with no criteria. Anyone who wishes will have access to data.

Locations

IR (1)