Clinical trial NCT05866120: Effects of Land and Water Physiotherapy on Motor Function in Parkinson's Disease
Official title: Effects of Physical Therapy on Land and Aquatic Physical Therapy on the Motor Function of Individuals With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson Disease
Physical Therapy Modalities
Muscle Strength
Aquatic Therapy
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
Collaborators: name: Federal University of Rio Grande do Sul
First posted: 2023-05-19
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess the effect of dry soil therapy and shallow water therapy on motor function in individuals with Parkinson's disease. Regarding the benefits, is there a difference between the therapies?

Detailed description: Parkinson's disease (PD) is a chronic progressive neurological disorder that involves motor and non-motor symptoms that commonly include bradykinesia, rigidity, tremor and postural instability and culminates in functional decline and disability. Postural instability is due to postural alterations that are commonly found in these individuals. Muscular disorders characterized by the inability to generate adequate synergy patterns may be responsible for postural instability, leading to postural alterations in the sagittal plane, often with the onset of hyperkyphosis. Exercise is increasingly being recognized as an effective and highly promising non-pharmacological intervention to improve muscle strength in PD. Typical land-based physical therapy treatment includes strength training, gait and balance training and has several benefits in reducing motor symptoms of PD. Interventions such as aquatic physical therapy have a growing body of evidence to support the efficacy of exercise in the PD population. Aquatic exercise has the intrinsic advantage of helping individuals lose body weight, leading to greater efficacy of the exercise itself. Knowing that muscle strength is associated with functional capacity and disease severity, physiotherapy becomes an important treatment resource with exercises to improve muscle strength and consequently reduce subsequent functional difficulties. However, due to the scattered evidence of physiotherapy in PD, there is insufficient evidence to prescribe a defined rehabilitation program for strengthening the trunk extensor muscles. Although there is increasing evidence of the effectiveness of land-based or aquatic therapies, the evidence is insufficient to support or refute the effectiveness of one physiotherapy intervention over another. Therefore, this study aims to describe and compare the effects of 12 weeks of land-based physical therapy and aquatic physical therapy on the motor function of individuals with PD, as well as to evaluate muscle strength, functional capacity, mobility, flexibility, muscle mass and balance, while examining the linear relationship between PD severity and these parameters. A Randomized Clinical Trial will be conducted, which will include individuals diagnosed with Parkinson's Disease, akinetic-rigid type, with postural instability, classified from 1 to 3 on the Hoehn and Yahr Scale, aged between 50 and 85 years, who sign the Free and Informed Consent Form, and have a minimum score of 26 on the Montreal Cognitive Assessment (MoCA).

Individuals will be randomized into two treatment groups: land-based physiotherapy and aquatic physiotherapy. The evaluation will be carried out in two stages: pre-intervention and post-intervention.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with Parkinson's Disease and rated from 1 to 3 on the Hoehn and Yahr Scale;
* With akinetic rigid type PD;
* Aged between 50 and 85 years old;
* Minimum score of 26 on the Montreal Cognitive Assessment (MoCA);
* Who sign the Free and Informed Consent Term (TCLE).

Exclusion Criteria:

* Parkinson's disease of the dominant tremor type;
* Previous associated neurological diseases;
* Severe heart diseases;
* Uncontrolled high blood pressure;
* Previous spine surgeries;
* Inflammatory diseases of the spine;
* Chlorine allergy;
* Aquaphobia.

Primary outcomes:
measure: MDS UPDRS Motor Assessment
timeFrame: 3 months
measure: Berg Scale and Romberg Test
timeFrame: 3 months
measure: Timed Up and Go (TUG)
timeFrame: 3 months
measure: Dual-energy X-ray absorptiometry
timeFrame: 3 months
measure: Ultrasonography
timeFrame: 3 months
measure: Isokinetic dynamometer - torque
timeFrame: 3 months
measure: Parkinson's Disease Questionnaire (PDQ-39)
timeFrame: 3 months
measure: Sit-and-Reach test
timeFrame: 3 months
measure: 30-second sit-to-stand test
timeFrame: 3 months
Secondary outcomes:
measure: Thigh and quadriceps muscle quality by specific tension and echo intensity
timeFrame: 3 months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Universidade de Ciências da Saúde de Porto Alegre
state: RS
Study officials:
References: