Aquatic High-Intensity Interval Training for Parkinson's Disease

May 12, 2026 updated by: Pardis Specialized Wellness Institute

The Effect of Aquatic High-Intensity Interval Training on Balance, Physical Function, and Sarcopenia in Patients With Parkinson's Disease: A Randomized Controlled Trial Protocol

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Parkinson's disease (PD) is a progressive neurodegenerative disorder characterized by motor and non-motor symptoms that impair quality of life. Pharmacological treatments alleviate motor symptoms but leave residual motor and non-motor complications and carry long-term adverse effects. Non-pharmacological therapies-particularly exercise-improve motor and non-motor outcomes via mechanisms such as enhanced dopamine release, corticostriatal plasticity, and increased BDNF after vigorous exercise. HIIT (including Tabata protocols) has emerging evidence for benefit in PD but land-based HIIT can be limited by balance deficits and fall risk. Aquatic HIIT may provide a safer environment (buoyancy, reduced joint load, natural resistance) and improve adherence.

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.

Study Type

Interventional

Enrollment (Actual)

56

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

  • Iran
      • Isfahan, Iran
        • Pardis specialized wellness institute

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.)
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of changes in Balance Ability
Time Frame: Pre-intervention and Week 8
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
Time Frame: Pre-intervention and Week 8
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)
Time Frame: Pre-intervention and Week 8
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
Time Frame: Pre-intervention and Week 8
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Quality of Life
Time Frame: Pre-intervention and Week 8
Evaluating improvements in quality of life using the Parkinson's Disease Questionnaire-39 (PDQ-39), a disease-specific 39-item self-report instrument covering eight domains (mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication, bodily discomfort). Items are rated on a 5-point Likert scale (0=never to 4=always), with domain scores transformed to 0-100 (higher indicating worse quality of life) and a summary index as the mean. The PDQ-39 has strong convergent validity (correlates with EQ-5D), discriminant validity, internal consistency (Cronbach's alpha=0.51-0.96), and test-retest reliability (0.56-0.90 per domain) in PD.
Pre-intervention and Week 8
Change in Sleep Quality
Time Frame: Pre-intervention and Week 8
Evaluating changes in sleep quality using the Pittsburgh Sleep Quality Index (PSQI), a 19-item self-report questionnaire (plus 5 roommate-rated items) assessing seven components (subjective quality, latency, duration, efficiency, disturbances, medication use, daytime dysfunction) over the past month. Global score sums to 0-21 (higher=worse sleep), with >5 indicating poor quality (prevalence ~85% in PD). The PSQI has good internal consistency (Cronbach's alpha=0.83), test-retest reliability (0.85), and validity in PD, correlating with PSG and other scales like PDSS.
Pre-intervention and Week 8
Adherence Rate
Time Frame: Week 0 to Week 8 (intervention period)
Determining adherence to the intervention using attendance logs, which record session participation as a percentage (number of attended sessions / total planned sessions; Adherence defined as attending ≥80% of sessions (≤20% missed)."). Logs also note reasons for non-attendance, providing qualitative insights. This method is reliable for monitoring exercise adherence in PD trials, with group rates often >80% in supervised programs, though individual accuracy requires caution.
Week 0 to Week 8 (intervention period)
Adverse Events
Time Frame: Week 0 to Week 12 (including 4-week follow-up)
Monitoring and reporting adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v5.0 or later), a standardized system categorizing events by organ system and severity grades (1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death-related). Events are defined as any unfavorable sign, symptom, or disease temporally associated with the intervention; serious events (grades 3-5) prompt reporting to DSMB. CTCAE ensures consistent AE reporting in clinical trials, with updates like v6.0 in 2025.
Week 0 to Week 12 (including 4-week follow-up)

Collaborators and Investigators

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

Sponsor

Pardis Specialized Wellness Institute

Investigators

  • Study Director: Mohammad Ali Tabibi, Dr, Pardis specialized wellness institute

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)

December 10, 2025

Primary Completion (Actual)

March 10, 2026

Study Completion (Estimated)

June 10, 2026

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

November 23, 2025

First Posted (Actual)

December 4, 2025

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PA25PKD-2-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data (IPD) that underlie the results reported in the published article, after deidentification are to be shared

IPD Sharing Time Frame

The data will be available starting 6 months after publication of primary results (anticipated March 2026). No end date.

IPD Sharing Access Criteria

Not applicable. It will be accessible for public.

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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