NCT04863118

Acute Effects of Strength Training and High Intensity Training on Functional and Biochemical Measurements of Individuals With Parkinson's Disease in Different Environments and Depths

Status unknown NA Last updated 12 February 2024

What this trial tests

NA trial testing Strength training in shallow water and dry land in Parkinson Disease and Hydrotherapy in 60 participants. Status unknown.

Timeline

1 November 2021

Primary endpoint
20 November 2023

30 April 2024

Quick facts

Lead sponsor	Federal University of Health Science of Porto Alegre
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	60
Start date	1 November 2021
Primary completion	20 November 2023
Estimated completion	30 April 2024
Sites	1 location across Brazil

Drugs / interventions tested

• Strength training in shallow water and dry land
• High-intensity training in shallow and deep water

Conditions studied

• Parkinson Disease and Hydrotherapy — all drugs for Parkinson Disease and Hydrotherapy →

Sponsor

Federal University of Health Science of Porto Alegre

Who can join

Adults 50 to 70, any sex, with Parkinson Disease and Hydrotherapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Introduction: Parkinson's disease (PD) is the second most common neurodegenerative disease in the elderly. Chronic and progressive, it includes loss of dopamine, a neurotransmitter involved in the regulation of movement. Thus, functional changes, such as postural disorders, trunk flexor pattern, muscle activation deficits, impairment of gait, balance, and mobility are common findings in this population. Once there is dopaminergic depletion, it is important to identify mechanisms that act in the production and survival of nigral dopaminergic neurons, like the brain-derived neurotrophic factor (BDNF). Studies describe a correlation between serum BDNF levels and PD motor dysfunction. Still, it is presumed that physical therapy can positively regulate substances that act directly on the Central Nervous System, such as BDNF. Physical exercise, in addition to promoting biochemical modulations in PD, can provide benefits in motor symptoms that sometimes do not improve with drugs. Conventional physiotherapy performed on dry land is a therapeutic resource used in PD. The conventional physiotherapy is useful for management of functional changes caused by PD due to muscle strengthening exercises. These exercises can be adapted and performed in water, at different depths, shallow and deep water. Thus, aquatic physiotherapy has been shown to be able to interfere in PD motor disorders, with perspective of maximizing the rehabilitation program effects due to the physical properties of water. These reasons, in addition to the large use of these interventions in the clinical practice and their likely benefits in the PD alterations, suggest the importance of studies in this area. Furthermore, the immediate effects of strengthening interventions with global extensor musculature emphasis on global extensor musculature, and of high-intensity training protocols, which encompass different environments and different depths, on functional and biochemical measures of PD are poorly studied.

Objectives: To verify the acute effects of a global extensor musculature strength training protocol, performed on dry land and shallow water, and of a high-intensity training protocol performed in shallow and deep water on functional and biochemical measurements of individuals with PD.

Methods: This will be a single-blind crossover, cross-sectional study with a 24-hour follow-up. The sample will be composed of subjects between 50 and 70 years old, classified from 1 to 3 in the Hoehn and Yahr scale, with a PD diagnosis rigid-akinetic and/or tremor-dominant type in the "OFF" period of the medication. In this research there will be an intervention group (IG) composed of individuals with Parkinson's disease and a control group (CG) of healthy individuals. Both will be randomly distributed in a randomized way and submitted to two different training sessions, for 60 minutes, at different times, in order to analyze the acute effects and follow-up of the following interventions: a strength training of the global extensor musculature in dry land and shallow water (120 cm deep) and high-intensity training (Borg Scale), at different depths: shallow water (120 cm deep) and deep water. To characterize the sample, anamnesis and Motor Examination of Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS III) will be performed. The individuals will be submitted to pre, post and 24h evaluations after the intervention. Functional measures will be analyzed: postural stability, by stabilometry; strength, by isokinetic dynamometry; spatiotemporal gait variables, with kinematic analysis; balance, with Berg Balance Scale and functional mobility with Timed Up and Go test and biochemical analysis: venous blood collection and ELISA test will be performed measuring serum BDNF levels. In this way, the acute effects of the global extensor musculature strength training protocol and of high-intensity training on the different variables analyzed, environments, depths and moments of evaluation will be analyzed and compared.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis.
   Ernst M, Folkerts AK, Gollan R, Lieker E, et al · · 2023 · cited 110× · PMID 36602886 · DOI 10.1002/14651858.cd013856.pub2
2. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis.
   Ernst M, Folkerts AK, Gollan R, Lieker E, et al · · 2024 · cited 37× · PMID 38588457 · DOI 10.1002/14651858.cd013856.pub3
3. Effects of aquatic and dry land physiotherapy on the functional capacity in individuals with and without parkinson's disease: a protocol study followed by a randomized clinical trial
   Scalco Acco F, Fiori Bortoli A, Frata B, Borin Aita JS, et al · · 2024 · DOI 10.12688/f1000research.156615.1