Aquatic High-Intensity Interval Training for Parkinson's Disease

NCT07264114 | Enrolling By Invitation DMC

• 1 other identifier: PA25PKD-2-01
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized, single-center, parallel-group superiority trial will evaluate the effect of an 8-week aquatic High-Intensity Interval Training (HIIT) program on balance, physical function, and sarcopenia-related outcomes in individuals with Parkinson's disease (PD). The intervention aims to deliver Tabata-style aquatic HIIT (3 sessions/week) in a therapeutic pool to determine adherence and preliminary efficacy compared with standard care (no structured exercise program).

Conditions

Parkinson Disease

Keywords

Parkinson's Disease; Aquatic Exercise; High-Intensity Interval Training; Balance; Sarcopenia; Quality of Life; Sleep Quality

Outcome Measures

Primary Outcomes (4)

• Rate of changes in Balance Ability

  Evaluating the effect of aquatic HIIT on balance using the Berg Balance Scale (BBS), a 14-item performance-based tool assessing static and dynamic balance through functional tasks like sitting to standing, reaching forward, and turning 360 degrees. Items are scored on a 5-point ordinal scale (0-4) based on ability and time to complete, with a total score ranging from 0 (worst) to 56 (best); scores of 0-20 indicate wheelchair-bound, 21-40 indicate walking with assistance, and 41-56 indicate independent. In PD, scores \<45 suggest high fall risk, and the BBS has excellent intra-rater reliability (ICC=0.98), inter-rater reliability (ICC=0.97), and criterion validity, correlating with other PD-specific measures like UPDRS.

  Pre-intervention and Week 8

• Rate of changes in Physical Function

  Evaluating the effect of aquatic HIIT on physical function using the Short Physical Performance Battery (SPPB), a composite test including three subcomponents: balance (holding side-by-side, semi-tandem, and tandem stands for up to 10 seconds each, scored 0-4), gait speed (timed 4-meter walk at usual pace, scored 0-4 based on time quartiles), and chair stand (time to complete five rises from a chair without arms, scored 0-4). Total score ranges from 0 (worst) to 12 (best), with scores \<10 indicating high risk for mobility limitations and falls in older adults, including PD patients. The SPPB demonstrates high test-retest reliability (ICC=0.92), intra-rater reliability, and validity in predicting functional decline and executive function associations in PD.

  Pre-intervention and Week 8

• Rate of changes in Muscle Mass (Sarcopenia)

  Evaluating the effect of aquatic HIIT on sarcopenia-related muscle mass using Bioelectrical Impedance Analysis (BIA), a non-invasive technique that estimates body composition by measuring resistance and reactance to a low-level electrical current, calculating skeletal muscle mass (ASM) and phase angle (PhA). ASM is indexed to height squared (ASM/height² in kg/m²), with sarcopenia diagnosed per EWGSOP2 criteria (\<7.0 kg/m² for men, \<5.5 kg/m² for women); PhA cut-offs for sarcopenia are ≤4.05° (92.9% sensitivity, 53.8% specificity) for men and ≤3.75° (78.9% sensitivity, 51.1% specificity) for women. In PD, BIA is reliable for detecting sarcopenia (prevalence 40-55%) with high correlation to dual-energy X-ray absorptiometry (DXA) as gold standard (r=0.85-0.90 for ASM), predictive validity (adjOR=0.147 for PhA), and good test-retest reliability (ICC=0.88-0.95), though wide diagnostic variations exist across criteria.

  Pre-intervention and Week 8

• Rate of changes in Muscle Strength

  Evaluating the effect of aquatic HIIT on muscle strength using a Handgrip Dynamometer, a handheld device that quantifies isometric grip force in kilograms or pounds during maximal voluntary contraction (typically 3 trials per hand, with the highest or average value used). Measurements are taken in a standardized seated position with the elbow flexed at 90 degrees; normative values decline with age, and low grip strength (\<27 kg men, \<16 kg women) is a sarcopenia criterion in PD. The dynamometer shows fair to excellent test-retest reliability (ICC=0.95-0.98) and intra-rater reliability in PD, with good validity for overall strength assessment.

  Pre-intervention and Week 8

Secondary Outcomes (4)

• Change in Quality of Life

  Pre-intervention and Week 8

• Change in Sleep Quality

  Pre-intervention and Week 8

• Adherence Rate

  Week 0 to Week 8 (intervention period)

• Adverse Events

  Week 0 to Week 12 (including 4-week follow-up)

Study Arms (2)

Aquatic HIIT group

EXPERIMENTAL

The participants in the experimental group will undertake supervised aquatic high-intensity interval exercise 3×/week for 8 weeks (Tabata method). Each session consists of a 10-min warm-up, Tabata sets (20s maximal-effort aquatic exercises-e.g., water running, jumping jacks, resistance with foam dumbbells/paddles-followed by 10s rest, 8 cycles/set; total set=4 min), and a 5-min cool-down. Intensity monitored using Borg RPE scale (6-20), target 15-17 ("hard" to "very hard") during work phases to ensure HIIT delivery. RPE recorded at end of each set with real-time feedback (e.g., "push harder" if \<15). Validated in PD trials; RPE 15-17 ≈80-90% max HR in water (HR optional). Pool depth waist-to-chest (≈1.2-1.4 m), temp 32-34 °C. Delivered in indoor therapeutic pool of Pardis Institute by certified specialists. Standard medical care continues. Adherence via attendance logs; \>20% missed = non-adherent.

Behavioral: Aquatic HIIT with adherence/support package

Control group

NO INTERVENTION

Patients allocated to the control group will receive their usual clinical management for Parkinson's disease, including pharmacological therapy as prescribed by their neurologist, and will not participate in any structured exercise program during the 8-week study period. Low-intensity daily activities and usual physical routines are permitted. Control participants will be advised to maintain their standard treatment regimen and customary activity patterns during the trial.

Interventions

Aquatic HIIT with adherence/support package BEHAVIORAL

The participants in the behavioral component will receive the same supervised aquatic HIIT program described above plus structured behavioral/support measures to maximize adherence and safety. These include: an initial individual education session explaining benefits/risks and protocol; supervised real-time feedback during each session from exercise specialists; flexible scheduling options to accommodate participants; weekly review of attendance and brief motivational follow-up (phone call or in-person) for participants with missed sessions; individualized adjustments to intensity/duration based on participant feedback and safety; and documentation of reasons for non-attendance. All behavioral/support activities are delivered by trained research staff and exercise physiologists and are recorded in session logs. (These measures are drawn from the protocol's adherence and retention strategies.)

Aquatic HIIT group

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PD stages 2-3 based on Hoehn and Yahr classification system
• Balance difficulty (BBS score \<45)
• Reduced motor function
• Sarcopenia (per EWGSOP2 criteria)
• Age ≥ 55
• Permission from their doctors to participate
• Absence of a history of myocardial infarction within the past 3 months
• Capacity to provide informed consent to participate in the study

You may not qualify if:

• Cardiac instability (angina, decompensated congestive heart failure, severe arteriovenous stenosis, uncontrolled arrhythmias, etc.)
• Active infection or acute medical illness
• Hemodynamic instability
• Labile glycemic control
• Inability to exercise (e.g. lower extremity amputation with no prosthesis)
• Severe musculoskeletal pain at rest or with minimal activity
• Inability to sit, stand or walk unassisted (walking device such as cane or walker allowed)
• Shortness of breath at rest or with activities of daily living

Sponsors & Collaborators

• Pardis Specialized Wellness Institute: lead

Study Sites (1)

Pardis specialized wellness institute

Isfahan, Iran

Location

Related Publications (13)

• Harpham C, Gunn H, Marsden J, Bescos Garcia R, Connolly L. Home-based high-intensity interval training for people with Parkinson's: Protocol for the HIIT-Home4Parkinson's randomized, controlled feasibility study. Health Sci Rep. 2024 Jan 7;7(1):e1800. doi: 10.1002/hsr2.1800. eCollection 2024 Jan.

  PMID: 38192731 BACKGROUND

• Kathia MM, Duplea SG, Bommarito JC, Hinks A, Leake E, Shannon J, Pitman J, Khangura PK, Coates AM, Slysz JT, Katerberg C, McCarthy DG, Beedie T, Malcolm R, Witton LA, Connolly BS, Burr JF, Vallis LA, Power GA, Millar PJ. High-intensity interval versus moderate-intensity continuous cycling training in Parkinson's disease: a randomized trial. J Appl Physiol (1985). 2024 Sep 1;137(3):603-615. doi: 10.1152/japplphysiol.00219.2024. Epub 2024 Jul 15.

  PMID: 39008618 BACKGROUND

• Volpe D, Giantin MG, Maestri R, Frazzitta G. Comparing the effects of hydrotherapy and land-based therapy on balance in patients with Parkinson's disease: a randomized controlled pilot study. Clin Rehabil. 2014 Dec;28(12):1210-7. doi: 10.1177/0269215514536060. Epub 2014 Jun 3.

  PMID: 24895382 BACKGROUND

• Hande D, Shinde S, Dhumale A, Kale HY. Effects of Aquatic-Based Resistance, Balance, and Proprioceptive Training on Ankle-Foot Malalignments in Postmenopausal Obese Women. Cureus. 2025 Jul 8;17(7):e87571. doi: 10.7759/cureus.87571. eCollection 2025 Jul.

  PMID: 40786333 BACKGROUND

• Li Y, Zhuang R, Zhang J, Liu X. The effect of different exercise training modes on improving quality of life in patients with Parkinson's disease: a network analysis. Front Neurol. 2025 Jul 2;16:1601080. doi: 10.3389/fneur.2025.1601080. eCollection 2025.

  PMID: 40672448 BACKGROUND

• Pezzini JV, Trevisan DD, Dominiak Soares VH, Gauer LE, Lima MMS. Sleep Quality in Parkinson Disease: Clinical Insights and PSQI Reliability Assessment. Sleep Sci. 2024 Oct 23;18(2):e147-e154. doi: 10.1055/s-0044-1791235. eCollection 2025 Jun.

  PMID: 40672893 BACKGROUND

• Berardi A, Galeoto G, Valente D, Conte A, Fabbrini G, Tofani M. Validity and reliability of the 12-item Berg Balance Scale in an Italian population with Parkinson's disease: A cross sectional study. Arq Neuropsiquiatr. 2020 Jul;78(7):419-423. doi: 10.1590/0004-282X20200030. Epub 2020 Jun 8.

  PMID: 32520233 BACKGROUND

• Petkus AJ, Foreman RP, Pilgrim M, Kim A, Hong E, Fisher BE, Van Horn JD, Wing D, Jakowec MW, Schiehser DM, Petzinger GM. Longitudinal associations between physical performance and cognition in individuals with Parkinson's disease. Clin Park Relat Disord. 2025 Jul 17;13:100370. doi: 10.1016/j.prdoa.2025.100370. eCollection 2025.

  PMID: 40756809 BACKGROUND

• Yilmaz M, Atik-Altinok Y, Seyidoglu Yuksel D, Acarer A, Bozkurt D, Savas S, Sarac ZF, Akcicek F. Evaluation of sarcopenia and phase angle in elderly patients with Parkinson's Disease. Int J Neurosci. 2025 Apr;135(4):488-495. doi: 10.1080/00207454.2024.2310180. Epub 2024 Feb 1.

  PMID: 38275120 BACKGROUND

• Villafane JH, Valdes K, Buraschi R, Martinelli M, Bissolotti L, Negrini S. Reliability of the Handgrip Strength Test in Elderly Subjects With Parkinson Disease. Hand (N Y). 2016 Mar;11(1):54-8. doi: 10.1177/1558944715614852. Epub 2016 Jan 14.

  PMID: 27418890 BACKGROUND

• Cugusi L, Manca A, Bergamin M, Di Blasio A, Monticone M, Deriu F, Mercuro G. Aquatic exercise improves motor impairments in people with Parkinson's disease, with similar or greater benefits than land-based exercise: a systematic review. J Physiother. 2019 Apr;65(2):65-74. doi: 10.1016/j.jphys.2019.02.003. Epub 2019 Mar 21.

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• Gamborg M, Hvid LG, Dalgas U, Langeskov-Christensen M. Parkinson's disease and intensive exercise therapy - An updated systematic review and meta-analysis. Acta Neurol Scand. 2022 May;145(5):504-528. doi: 10.1111/ane.13579. Epub 2022 Jan 8.

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MeSH Terms

Conditions

Parkinson Disease; Sarcopenia; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Study Officials

• Mohammad Ali Tabibi, Dr

  Pardis Specialized Wellness Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: None (Open Label) for participants and care providers; Single (Outcomes Assessor) for functional tests; Blinded data analysis."
• 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: November 18, 2025
• First Posted: December 4, 2025
• Study Start: December 10, 2025
• Primary Completion: March 10, 2026
• Study Completion (Estimated): May 10, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will be available starting 6 months after publication of primary results (anticipated March 2026). No end date.
• Access Criteria: Not applicable. It will be accessible for public.

Locations

IR (1)