Biological impact of an intensive 21-day spa recovery program on quality of life and cell health in Parkinson’s disease

ISRCTN ISRCTN11301892
DOI https://doi.org/10.1186/ISRCTN11301892
Sponsor Slovak Research and Development Agency
Funder Agentúra na Podporu Výskumu a Vývoja
Submission date
11/05/2026
Registration date
12/05/2026
Last edited
12/05/2026
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Martin Kolisek
Principal investigator

BioMed Martin, JLF UK, Comenius University in Bratislava
Mala Hora 4D
Martin
03601
Slovakia

+421 (0)950577501
martin.kolisek@uniba.sk
Dr Alena Korencikova
Scientific

SLKP Piešťany
Kúpeľný ostrov 29
Piešťany
92129
Slovakia

+421 (0)337757733
akorencikova@ensanahotels.com
Mrs Lucia Rahelova
Public

BioMed JLF UK
Mala Hora 4D
Martin
03601
Slovakia

+421 (0)43 9279698
lucia.rahelova@uniba.sk

Study information

Primary study designInterventional
AllocationN/A: single arm study
MaskingOpen (masking not used)
ControlUncontrolled
AssignmentSingle
PurposePrevention, Supportive care, Treatment
Scientific titleMultimodal adjuvant therapy of Parkinson's disease and its impact on quality of life and the deep proteomic network
Study objectives The objective of this study is to resolve the systemic molecular architecture of recovery following the 21-day Parkinson Spa Recovery (PSR) protocol, an intensive program integrating balneotherapy, neurophysiotherapy, and targeted nutrition.
Ethics approval(s)

Approved 18/10/2023, Ethical Committee at Jessenius Faculty of Medicine in Martin, Comenius University in Bratislava (Mala Hora 4A, Martin, 03601, Slovakia; +421 (0)432633604; jana.mahutova@uniba.sk), ref: EK59/2023

Health condition(s) or problem(s) studiedParkinson's disease
InterventionParticipants completed a 21-day inpatient multimodal PSR rehabilitation programme at the Slovak Health Spa Piešťany. The regimen totalled 63 therapeutic interventions (three sessions daily) across three specialised modules:
1. Balneotherapy and physical rehabilitation: daily balneological treatments utilised natural medicinal mineral water or hydrogen-sulphide-rich peloid therapy. Bespoke physiotherapy sessions (2×/week) addressed individual musculoskeletal imbalances, focusing on gait dynamics and postural stability. Structured group exercises (3×/week) incorporated aquatic therapy, hydro-cycling, neuro-specific gym training, and Nordic walking. Adjunctive therapies, including hydromassage, parafango (paraffin-peloid), magnetotherapy, laser therapy, and phototherapy (biolamp), were administered according to individual clinical indications.
2. Sensory modulation: a multi-sensory stimulation protocol provided visual cues (high-contrast floor markers), auditory stimuli (rhythmic and meditative acoustics), and somatosensory inputs (aromatherapy) to facilitate motor planning and emotional regulation.
3. Nutraceutical intervention and hydropinic (mineral water) therapy: participants adhered to a controlled dietary regimen integrating principles of the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet. The nutritional protocol was standardised to a mean daily energy intake of 2000 kcal, administered across three equal meals. The target macronutrient distribution was 20% protein (100 g), 60% carbohydrates (300 g), and 20% lipids (44.4 g), aligning with established Acceptable Macronutrient Distribution Ranges (AMDR, IOM 2002/2005). This regimen emphasised neuroprotective food groups, including leafy greens, berries, and healthy fats, while restricting processed sugars and saturated lipids. Hydropinic therapy consisted of drinking 100 ml natural medicinal water 1-3 times daily (titrated to individual tolerance). To optimize mineral absorption and metabolic influence, servings were administered 30 minutes pre-prandially.
Intervention typeOther
Primary outcome measure(s)
  1. Patient-reported quality of life, objective motor performance, and functional autonomy in activities of daily living, measured using self-reported 39-item Parkinson's disease questionnaire (PDQ-39), 16-item, 3 -domain Modified Parkinson Activity Scale (mPAS), and 11-point Schwab and England Activities of Daily Living Scale (S&E ADL) at before treatment (T0), after treatment (21 days) (T1), and for PDQ-39 also 4 weeks post treatment (T2)
  2. Basic clinical biochemical and hematological parameters measured using various clinically certified methods: Absolute Basophil Count (109/L), Absolute Eosinophil Count (109/L), Absolute Lymphocyte Count (109/L), Absolute Monocyte Count (109/L), Absolute Neutrophil Count (109/L), Atherogenic Index Basophils (%), C-Reactive Protein (mg/L), Eosinophils (%), Hematocrit Hemoglobin (g/L), Interleukin 1-alpha (pg/mL), Interleukin 1-beta (pg/mL), Interleukin 6 (pg/mL), Lymphocytes (%), Mean Corpuscular Hemoglobin (pg), Mean Corpuscular Hemoglobin Concentration (g/L), Mean, Corpuscular Volume (fL), Monocytes (%), Neutrophils (%), Platelet Distribution Width (fL), Platelets (109/L), Red Blood Cells (1012/L), S-Uric Acid (μmol/L), S-Alanine Aminotransferase (μkat/L), S-Aspartate Aminotransferase (μkat/L), S-Calcium (mmol/L), S-Creatine Kinase (μkat/L), S-Creatinine (μmol/L), S-Glucose (mmol/L), S-High-Density Lipoprotein (mmol/L), S-Cholesterol (mmol/L), S-Potassium (mmol/L), S-Low Density Lipoprotein Cholesterol (mmol/L), S-Magnesium (mmol/L), S-Sodium (mmol/L), S-non-High Density Lipoprotein Cholesterol (mmol/L), S-Phosphate (mmol/L), S-Triglycerides (mmol/L), S-Urea (mmol/L), White Blood Cells (109/L) at before treatment and 21 days after treatment (T1)
  3. Qualitative and quantitative features of plasma proteome measured using deep aptamer proteomics profiling at before (T0) and 21 days after (T1)
Key secondary outcome measure(s)
Completion date29/05/2025

Eligibility

Participant type(s)
Age groupMixed
Lower age limit40 Years
Upper age limit80 Years
SexAll
Target sample size at registration35
Total final enrolment32
Key inclusion criteriaParkinson's disease patients with mild-to-moderate impairment, classified as Hoehn and Yahr stages 1-3
Key exclusion criteria1. Infectious diseases: infectious diseases transmissible to humans and being a carrier of pathogens; all diseases in the acute stage
2. Cardiovascular conditions: clinical signs of circulatory failure, post-deep vein thrombosis conditions within 3 months of recovery, post-superficial thrombophlebitis conditions within six weeks of recovery, hypertension with diastolic pressure above 16 kPa (120 mm Hg)
3. Metabolic conditions: labile or decompensated diabetes mellitus, frequently recurring profuse bleeding of any kind, cachexia (wasting syndrome) of any kind, malignant tumors during and after treatment with clinically confirmed signs of disease progression
4. Neurological and psychiatric conditions: epilepsy (except for cases where no seizures have occurred in the last year),
active attacks or phases of psychosis and mental disorders with antisocial behavior or impaired communication, alcohol or drug dependency, dementia
5. General and physiological conditions: stage III urinary and fecal incontinence, enuresis nocturna (bedwetting), pregnancy, non-healing skin defects of any origin
Date of first enrolment17/02/2024
Date of final enrolment18/09/2024

Locations

Countries of recruitment

  • Slovakia

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to shareNo

Editorial Notes

12/05/2026: Study's existence confirmed by the Ethical Committee at Jessenius Faculty of Medicine in Martin, Comenius University in Bratislava.

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