Effects of Different Physical Therapies and Dance in People With Parkinson's Disease

NCT ID: NCT03860649

Last Updated: 2020-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2022-12-30

Brief Summary

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The aim of study is to analyze the effects of different physical therapies (Aquatic Jogging, Neurofunctional Physiotherapy, Pilates Training and Nordic Walking) and Dance and compare with unsupervised home exercises in the clinical-functional parameters, postural balance, muscular echographic quality, pendulum gait mechanism, and serum levels of BDNF in people with Parkinson's disease with camptocormia or Pisa Syndrome.

Detailed Description

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Objective: Analyze the effects of different physical therapies (Aquatic Jogging, Neurofunctional Physiotherapy, Pilates Training and Nordic Walking) and Dance and compare with unsupervised home exercises in the clinical-functional parameters, postural balance, muscular echographic quality, pendulum gait mechanism, and serum levels of brain-derived neurotrophic factor (BDNF) in people with Parkinson's disease with camptocormia or Pisa Syndrome. Experimental Design: Randomized controlled clinical trial with translational study characteristics. Search Location: Exercise Research Laboratory at the School of Physical Education, Physiotherapy and Dance, Federal University of Rio Grande do Sul, and in the Movement Disorders Outpatient Clinic of the Hospital of Clinicals of Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil. Participants: 100 patients from the Unified Health System (UHS) of both sexes, from 50 to 80 years old, diagnosed with idiopathic PD, sedentary. Interventions: In this research, four groups of patients with PD will receive intervention during 4 months of different physical therapy programs (Nordic walking, aquatic jogging and supervised neurofunctional physiotherapy) and dance; and a control group, who will receive telephone guidance for performing home-based exercises. The training programs will have a duration of 4 months and will be periodized so that the duration of the sessions is matched between them. The intensity of the interval training will be manipulated by the subjective effort scale (Borg) and by the heart rate, with predetermined series durations. All training programs will have a frequency of two sessions per week and a duration of 60 minutes. In order to evaluate the effects of the training, evaluations will be performed before and after the training period: 1) Basal (month 0): initial pre-training evaluation; 2) month 4: Evaluation 48h after the last training session. Outcomes: clinical-functional parameters, postural balance, muscular echographic quality, pendulum gait mechanism, and biochemistry. Data Analysis: Data will be described by average values and standard deviation values. The comparisons between and within groups will be performed using a Generalized Estimating Equations (GEE) analysis, adopting a level of significance (α) of 0.05. Expected Results: The intervention groups of the different physical therapies and dance are expected to be more effective in all outcomes analyzed, especially improving functional mobility when compared to the control group of unsupervised home exercises. In addition, it is expected that the results of the research will be expandable and the possibility of future developments in the scientific, technological, economic, social and environmental fields and that they will be implemented in the Unified Health System (UHS).

Conditions

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Parkinson Disease Parkinson Disease 10

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
double-blind (Investigator, Outcomes Assessor)

Study Groups

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Nordic Walking

The patient walk program consists of 3 moments: warm up, walk and stretch. They will do a brief free walking warm-up for 3 minutes in the Self-selected walking speed - SSWS (3 'SSWS), then walk according to the training cycle, the intensity will be between 60 to 80% of the Heart of Ratio reserve. In addition, the intensity of the classes will be measured in each phase by the Borg Scale of Perceived Exertion.

Group Type EXPERIMENTAL

Nordic Walking

Intervention Type OTHER

24 sessions will be held twice a week, with each session taking an average of 60 minutes.

Jogging

This group will undergo 24 Dance sessions. Aquatic therapy patients will receive deep water running intervention with the use of flotation vests. The exercises will consist of: immersion, balance, strength, agility, and movement within the water. The intensity of the classes will be measured in each moment and by the Borg Scale of Perceived Exertion.

Group Type EXPERIMENTAL

Jogging

Intervention Type OTHER

24 sessions will be held twice a week, with each session taking an average of 60 minutes.

Dance

This group will undergo 24 Dance sessions inspired by Forró dance rhythm and Samba dance rhythm. Classes will be divided into four stages: Joint warm up and stretching on the chairs; strengthening, balance and rhythm exercises with the support of the barre; exercises inspired by the Samba and Forró dance (Brazilian ballroom dance) basic steps; and Final cool down. The intensity of the classes will be measured according to the beats per minute (BPMs) of the songs used in each moment and by the Borg Scale of Perceived Exertion.

Group Type EXPERIMENTAL

Dance

Intervention Type OTHER

24 sessions will be held twice a week, with each session taking an average of 60 minutes.

Pilates Training

Classes composed of three phases: Warming up, main part and back to calm. Warming up will begin with pre-Pilates training exercises for 5 minutes (eg. breathing exercises, hip joint mobilization, shoulder girdle, etc.), the main part of the lesson will be the Pilates training drill sequence for the beginner level that will be conducted for 50 minutes in which all exercises will be performed on the floor.

The sequence of the eighteen exercises of the main part of the lesson is described in the table below. Back to Calm: will be carried out for 5 final minutes with standing exercises with the subject reclining on the wall to reconnect the subject with orthostatic posture.

In the each of the phases of the lesson will be shown to the subject the table of BORG with the objective of measuring the intensity of perceived exertion, using the Borg Scale of Perceived Exertion.

Group Type EXPERIMENTAL

Pilates Training

Intervention Type OTHER

24 sessions will be held twice a week, with each session taking an average of 60 minutes.

Interventions

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Nordic Walking

24 sessions will be held twice a week, with each session taking an average of 60 minutes.

Intervention Type OTHER

Jogging

24 sessions will be held twice a week, with each session taking an average of 60 minutes.

Intervention Type OTHER

Dance

24 sessions will be held twice a week, with each session taking an average of 60 minutes.

Intervention Type OTHER

Pilates Training

24 sessions will be held twice a week, with each session taking an average of 60 minutes.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Volunteers
* aged over 40 years
* both sexes
* clinical diagnosis of idiopathic PD
* PD staging between 1 and 4 in Hoehn and Yahr Scale (H\&Y).

Exclusion Criteria

* performing recent surgeries, deep brain stimulation (DBS - Deep Brain Stimulations);
* severe heart diseases, uncontrolled hypertension, myocardial infarction within a period of less than one year, being a pacemaker;
* stroke or other associated neurological diseases; insanity;
* prostheses in the lower limbs;
* without ambulation conditions.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aline Nogueira Haas

UNKNOWN

Sponsor Role collaborator

Flávia Gomes Martinez

UNKNOWN

Sponsor Role collaborator

Federal University of Rio Grande do Sul

OTHER

Sponsor Role lead

Responsible Party

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Leonardo A. Peyré-Tartaruga

Adjunct Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Leonardo Alexandre Peyré-Tartaruga, PhD

Role: STUDY_DIRECTOR

Federal University of Rio Grande do Sul

Locations

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Federal University of Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

References

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Other Identifiers

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LTartaruga,PPT-Parkinson

Identifier Type: -

Identifier Source: org_study_id

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