NCT07264114

Aquatic High-Intensity Interval Training for Parkinson's Disease

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Pardis Specialized Wellness Institute · Academic / Other
• Sex: All
• Age: 55 Years – 75 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
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.)

Timeline

• Start date: 2025-12-10
• Primary completion: 2026-03-10
• Completion: 2026-04-10
• First posted: 2025-12-04
• Last updated: 2026-02-18

Locations

1 site across 1 country: Iran