Aquatic High-Intensity Interval Training for Parkinson's Disease
NCT ID: NCT07264114
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
56 participants
INTERVENTIONAL
2025-12-10
2026-04-10
Brief Summary
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Detailed Description
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This single-center trial will recruit 56 participants (aged 55-75) with PD (Hoehn \& Yahr stages 2-3) and balance difficulty to be randomized 1:1 to aquatic HIIT (n=28) or control (standard care; n=28). The intervention comprises 8 weeks of supervised Tabata-format aquatic sessions (20s high intensity/10s rest ×8 cycles per set; warm-up and cool-down included) three times weekly. Primary endpoints include changes in Berg Balance Scale (BBS), Short Physical Performance Battery (SPPB), skeletal muscle mass by BIA, and handgrip strength from baseline to Week 8 (primary endpoint), with safety follow-up to Week 12. Secondary endpoints include PDQ-39, PSQI, adherence, and adverse events monitored with CTCAE criteria.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Aquatic HIIT group
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.
Aquatic HIIT with adherence/support package
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.)
Control group
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.
No interventions assigned to this group
Interventions
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Aquatic HIIT with adherence/support package
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.)
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
55 Years
75 Years
ALL
No
Sponsors
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Pardis Specialized Wellness Institute
OTHER
Responsible Party
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Principal Investigators
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Mohammad Ali Tabibi, Dr
Role: STUDY_DIRECTOR
Pardis Specialized Wellness Institute
Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Yang Y, Wang G, Zhang S, Wang H, Zhou W, Ren F, Liang H, Wu D, Ji X, Hashimoto M, Wei J. Efficacy and evaluation of therapeutic exercises on adults with Parkinson's disease: a systematic review and network meta-analysis. BMC Geriatr. 2022 Oct 21;22(1):813. doi: 10.1186/s12877-022-03510-9.
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.
Other Identifiers
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PA25PKD-2-01
Identifier Type: -
Identifier Source: org_study_id
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