Parkinson DiseaseNCT07264114

Aquatic High-Intensity Interval Training for Parkinson's Disease

A study testing Aquatic HIIT with adherence/support package in people with Parkinson Disease, run by Pardis Specialized Wellness Institute at 1 site in Iran.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 55 to 75 years
Conditions the study is for: Parkinson Disease
What is being tested?: Aquatic HIIT with adherence/support package
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 56 participants
Where: 1 siteIran
Study dates: 10 Dec 2025to 10 Jun 2026
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 55 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Iran1 site

Pardis specialized wellness institute
Isfahan

Other trials in Iran

About this study

Official title: 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).

Read the 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
Being tested: Aquatic HIIT with adherence/support package
Keywords: Parkinson's Disease, Aquatic Exercise, High-Intensity Interval Training, Balance, Sarcopenia, Quality of Life, Sleep Quality
Medical subject headings: Parkinson Disease, Sarcopenia, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Aquatic HIIT with adherence/support packageBehavioural
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.)

Study groups in NCT07264114
Study group	Role	What they receive
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. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-intervention and Week 8

Secondary outcomes (4)

Change in Quality of Life
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.
Measured: Pre-intervention and Week 8
Change in Sleep Quality
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.
Measured: Pre-intervention and Week 8
Adherence Rate
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.
Measured: Week 0 to Week 8 (intervention period)
Adverse Events
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.
Measured: Week 0 to Week 12 (including 4-week follow-up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Dec 202510 Jun 2026

First posted4 Dec 2025
Study start10 Dec 2025
Primary completion10 Mar 2026
Study completion10 Jun 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Model description: Participants will be randomly allocate to intervention group or control group and will be examined in the same way.
Masking: None (open label)
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07264114
Sponsor's protocol ID: PA25PKD-2-01
Status last verified: Jul 2026
First submitted: 18 Nov 2025
Last updated: 6 Jul 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Individual participant data (IPD) that underlie the results reported in the published article, after deidentification are to be shared

Publications

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.
PubMed 38192731
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.
PubMed 39008618
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.
PubMed 24895382
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.
PubMed 40786333
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.
PubMed 40672448
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.
PubMed 40672893
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.
PubMed 32520233
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.
PubMed 40756809
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.
PubMed 38275120
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.
PubMed 27418890
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.
PubMed 30904467
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.
PubMed 36271367
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.
PubMed 34997759

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT07264114
Acronym / sponsor ID: PA25PKD-2-01
Conditions: Parkinson Disease
Keywords: Parkinson's Disease, Aquatic Exercise, High-Intensity Interval Training, Balance, Sarcopenia, Quality of Life, Sleep Quality
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: Pardis Specialized Wellness InstituteUniversity, hospital or other
Study start: 10 Dec 2025 (actual)
Primary completion: 10 Mar 2026 (actual)
Study completion: 10 Jun 2026 (actual)
First posted: 4 Dec 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Participants will be randomly allocate to intervention group or control group and will be examined in the same way.

Arm	Type	Receives
Aquatic HIIT group	Experimental	Behavioral: Aquatic HIIT with adherence/support packageThe 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.
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.

Who may qualify

Ages: 55 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (8 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Aquatic HIIT with adherence/support packageThe 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.)	Behavioural	Aquatic HIIT group

Primary outcome

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.
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.
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.
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.

4 secondary outcomes

Change in Quality of Life
Time frame: Pre-intervention and Week 8
Change in Sleep Quality
Time frame: Pre-intervention and Week 8
Adherence Rate
Time frame: Week 0 to Week 8 (intervention period)
Adverse Events
Time frame: Week 0 to Week 12 (including 4-week follow-up)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
Background: PubMed 38192731Harpham 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.
Background: PubMed 39008618Kathia 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.
Background: PubMed 24895382Volpe 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.
Background: PubMed 40786333Hande 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.
Background: PubMed 40672448Li 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.
Background: PubMed 40672893Pezzini 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.
Background: PubMed 32520233Berardi 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.
Background: PubMed 40756809Petkus 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.
Background: PubMed 38275120Yilmaz 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.
Background: PubMed 27418890Villafane 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.
Background: PubMed 30904467Cugusi 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.
Background: PubMed 36271367Yang 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.
Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie the results reported in the published article, after deidentification are to be shared

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mohammad Ali Tabibi, Dr study director

Pardis Specialized Wellness Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Aquatic HIIT with adherence/support package in people with Parkinson Disease, run by Pardis Specialized Wellness Institute at 1 site in Iran.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of changes in Balance Ability (time frame: Pre-intervention and Week 8). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07264114, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.