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

NCT ID: NCT04863118

Last Updated: 2024-02-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2024-04-30

Brief Summary

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.

Conditions

Parkinson Disease and Hydrotherapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Strength training protocol performed in shallow water and dry land

Parkinson Disease and healthy individuals

Group Type: EXPERIMENTAL

Strength training in shallow water and dry land

Intervention Type: OTHER

Dry land: The intervention will last for 60 minutes, consisting of exercises to strengthen the global extensor musculature, that is, involving the upper limbs, trunk and lower limbs. Weights and equipment for strength training will be used. The sessions will start with 10 minutes of warm-up, the central part of exercises to strengthen the extensor muscles and the last part will consist of oriented stretches. In the central part, a typical strength training will be performed (2-6 series; 85% of RM), using submaximal subjective effort and with repetition control.

Shallow water: The intervention performed on dry land will be adapted and produced in an aquatic environment. Aquatic implements will be used for strength training.

High-intensity training protocol performed in shallow and deep water

Parkinson Disease and healthy individuals

Group Type: EXPERIMENTAL

High-intensity training in shallow and deep water

Intervention Type: OTHER

Shallow water: The intervention will last 60 minutes. The exercises consist of: immersion, balance, strength, agility and displacement in the water. As they will start with 10 minutes of warm-up and the last part will consist of stretches oriented along the edge of the pool and on the depth reduction platform. In the main part of the intervention, different styles of exercises will be performed, with or without the use of implements. Displacements will have varying speeds in the same session, defined by Borg's Scale of subjective sensation of effort.

Deep water: The intervention carried out in shallow water will be adapted with the use of floating belts and reproduced in deep water.

Interventions

Strength training in shallow water and dry land

Dry land: The intervention will last for 60 minutes, consisting of exercises to strengthen the global extensor musculature, that is, involving the upper limbs, trunk and lower limbs. Weights and equipment for strength training will be used. The sessions will start with 10 minutes of warm-up, the central part of exercises to strengthen the extensor muscles and the last part will consist of oriented stretches. In the central part, a typical strength training will be performed (2-6 series; 85% of RM), using submaximal subjective effort and with repetition control.

Shallow water: The intervention performed on dry land will be adapted and produced in an aquatic environment. Aquatic implements will be used for strength training.

Intervention Type: OTHER

High-intensity training in shallow and deep water

Shallow water: The intervention will last 60 minutes. The exercises consist of: immersion, balance, strength, agility and displacement in the water. As they will start with 10 minutes of warm-up and the last part will consist of stretches oriented along the edge of the pool and on the depth reduction platform. In the main part of the intervention, different styles of exercises will be performed, with or without the use of implements. Displacements will have varying speeds in the same session, defined by Borg's Scale of subjective sensation of effort.

Deep water: The intervention carried out in shallow water will be adapted with the use of floating belts and reproduced in deep water.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

GI (Individuals with Parkinson Disease):

• Individuals diagnosed with Parkinson's disease for at least 6 months;
• Age between 50 to 70 years;
• Classified on the Hoehn and Yahr scale from 1 to 3;
• Rigid-akinetic and/or tremor-dominant type;
• Individuals who have preserved their cognitive skills, assessed by means of the Mini Mental State Examination (MMSE) and who have a cut-off score of 23/24 (FOLSTEIN et al., 1975).

GC (Healthy individuals):

• Age between 50 to 70 years;
• Individuals who have preserved their cognitive skills (with the same cut-off score as the GI in the MMSE);
• Walk independently.

Exclusion Criteria

GI (Individuals with Parkinson Disease):

• Individuals who have other associated musculoskeletal and neurological disorders;
• Individuals with dementia installed;
• Individuals with pathologies and injuries associated with the skin that make it impossible to enter the aquatic environment;
• Individuals with hydrophobia.

GC (Healthy individuals):

• Individuals who have musculoskeletal and neurological pathologies;
• Individuals with dementia installed;
• Individuals with pathologies and injuries associated with the skin that make it impossible to enter the aquatic environment;
• Individuals with hydrophobia.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Federal University of Health Science of Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Fernanda Cechetti

Clinical Professor, Ph.D, Fernanda Cechetti

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fernanda Cechetti

Porto Alegre, Rio Grande do Sul, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

UFCSPA FUHSPortoAlegre

Role: CONTACT

cep@ufcspa.edu.br

(51)3303-8804

Facility Contacts

Fernanda Cechetti

Role: primary

References

Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

Reference Type: DERIVED

PMID: 38588457 (View on PubMed)

Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

Reference Type: DERIVED

PMID: 36602886 (View on PubMed)

Other Identifiers

DPEAQ21

Identifier Type: -

Identifier Source: org_study_id