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

Parkinson Disease Clinical Trial

Official title:

Effects of Different Physical Therapies and Dance on Clinical and Functional Parameters, Muscle Quality, Pendular Mechanism of the Gait and Brain-derived Neurotrophic Factor in People With Parkinson's Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03860649
• Other study ID #: LTartaruga,PPT-Parkinson
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: December 30, 2022

Study information

• Verified date: June 2020
• Source: Federal University of Rio Grande do Sul
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 30, 2022
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson Disease 10

Intervention

Other:
• Nordic Walking
24 sessions will be held twice a week, with each session taking an average of 60 minutes.
• Jogging
24 sessions will be held twice a week, with each session taking an average of 60 minutes.
• Dance
24 sessions will be held twice a week, with each session taking an average of 60 minutes.
• Pilates Training
24 sessions will be held twice a week, with each session taking an average of 60 minutes.

Locations

Country	Name	City	State
Brazil	Federal University of Rio Grande do Sul	Porto Alegre	Rio Grande Do Sul

Sponsors (3)

Lead Sponsor	Collaborator
Federal University of Rio Grande do Sul	Aline Nogueira Haas, Flávia Gomes Martinez

Country where clinical trial is conducted

Brazil, 

References & Publications (32)

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Motor symptoms	This outcome will be evaluated using Unified Parkinson's Disease Rating Scale (UPDRS). This Scale the clinician-scored monitored motor evaluation. Will be to considered 30% improvement in motor symptoms has been applied to identify "responsive people". The score in each item ranges from 0 to 4, and the indicates greater impairment by the disease and the minimum, normality. The 14 items in the motor vehicle (the numbering of which goes from 18 to 31).	Change from baseline at 12 weeks.
Other	Freezing of Gait	The freezing of gait questionnaire (FOG-Q) has 6 questions and a total score of 0 to 24. A higher score corresponds to the more severe presence of freezing of gait and a lower score is equivalent to a lower presence or absence of freezing of gait .	Change from baseline at 12 weeks.
Other	Balance Static	The force platform will be used for the anteroposterior displacement of the center of pressure (COP)- COPx (in centimeters) and mediolateral - COPy (in centimeters) of the pressure center.	Change from baseline at 12 weeks.
Other	Spatial Parameter - Stride length	This outcome is measure by stride length in meters. This parameter will be measure before and after the nordic walking, dance and jogging aquatic interventions.	Change from baseline at 12 weeks.
Other	Temporal Parameter - Swing time, contact time, time of balance	Swing time in seconds, contact time in seconds, time of balance in seconds. The percentage of contact time will be calculated to measure the duty factor in percentual.; The swing and contact time in seconds will be aggregated to distance in meters to arrive at frequency (in Hetz). These parameters will be measure before and after the nordic walking, dance and jogging aquatic interventions.	Change from baseline at 12 weeks.
Other	Anthropometric data - Body mass	Body mass will be measure in kilograms before and after the nordic walking, dance and jogging aquatic interventions.; These data will be measured in scale, stadiometer and anthropometric tape. All this parameters will be measure before and after the nordic walking, dance and jogging aquatic interventions.	Change from baseline at 12 weeks.
Other	Anthropometric data - Height	Height will be measure in meters before and after the nordic walking, dance and jogging aquatic interventions.	Change from baseline at 12 weeks.
Other	Anthropometric data - Circumference	Circumference of body will be measure in centimeters before and after the nordic walking, dance and jogging aquatic interventions.	Change from baseline at 12 weeks.
Other	Anthropometric data - Body Mass Index	Weight and height will be combined to report the body mass index in kg/m2. This parameter will be measure before and after the nordic walking, dance and jogging aquatic interventions.	Change from baseline at 12 weeks.
Other	Electromyographic Parameters	This outcome is measure is a composite for: mean amplitude, onset, offset and time of the signal and co-contraction of the muscles: vastus lateralis (VL), biceps femoris (BF), anterior tibial (AT) and medial gastrocnemius (MG) all variables in percentage. This outcome will be measured through measuring the electromyographic activation during treadmill walking tests using an electromyograph.	Change from baseline at 12 weeks.
Other	Parameters of Pendular Mechanism - Internal Work	The transduction between the potential and kinetic mechanical energies of the center of body mass (called the "inverted pendulum" mechanism). The internal work is the mechanical energy fluctuations of the movement of limbs relative to the center of body mass (Wint, in Joules). This outcome will be measured through the registered image movement analysis using the three-dimensional motion analysis system VICON of the walking test on the treadmill.	Change from baseline at 12 weeks.
Other	Parameters of Pendular Mechanism: external work	The transduction between the potential and kinetic mechanical energies of the center of body mass (called the "inverted pendulum" mechanism). The external work is energy fluctuations of the center of body mass with respect to the external environment or surroundings (Wext, in Joules). This outcome will be measured through the registered image movement analysis using the three-dimensional motion analysis system VICON of the walking test on the treadmill.	Change from baseline at 12 weeks.
Other	Parameters of Pendular Mechanism: total mechanical work	The transduction between the potential and kinetic mechanical energies of the center of body mass (called the "inverted pendulum" mechanism). The total mechanical work (Wtot =Wext + Wint) produced by a body during activity. These outcomes are measured by composite for:(external, internal mechanical work, in Joules). This outcome will be measured through the registered image movement analysis using the three-dimensional motion analysis system VICON of the walking test on the treadmill.	Change from baseline at 12 weeks.
Other	Parameters of Pendular Mechanism: Recovery	The mechanical energy exchange of the center of mass is quantified by the calculation of the percentage of reconversion of mechanical energy, called Recovery (R), which counts the form that the mechanical energy is saved through the pendulum mechanism of the locomotion. This outcome will be measured through the registered image movement analysis using the three-dimensional motion analysis system VICON of the walking test on the treadmill.	Change from baseline at 12 weeks.
Other	Motor behavior by electromyographic activity	During the gait initiation, sit-to-stand movement and go up and down one step, the investigators will evaluate the anticipatory postural adjustments and compensatory postural adjustments. The electromyograph will be used to obtain electromyographic activity data of the spinal erector muscles, internal oblique, gluteus medius, rectus femoris, femoral biceps, medial gastrocnemius and tibialis anterior (in mV).; All these parameters will be measured before and after Nordic walking, dance and jogging interventions.	Change from baseline at 12 weeks.
Other	Muscular activation	Muscular activation during phases of the gait cycle of people with Parkinson's disease through the electromyographic evaluation of the muscles of the spinal erector, internal oblique, gluteus medius, rectus femoris, femoral biceps, anterior tibialis and medial gastrocnemius during treadmill running. All participants will walk on a treadmill at selected walking speed. To identify electromyographic activity during the different gait cycles, the electromyograph will be synchronized with VICON (Vicon Motion Capture System - Oxford - USA, 1984).	Change from baseline at 12 weeks.
Other	Scapular and pelvis coordination parameters	The scapular girdle movement in angles will be measure, pelvic girdle in angles will be measure.; The scapular girdle movement in angles will be aggregated to pelvic girdle in angles to arrive at continuous and discrete phases coordinations in angles.; All these parameters will be measure before and after the nordic walking, dance and jogging aquatic interventions.	Change from baseline at 12 weeks.
Other	Angular variables	Tilt pelvic in angle, flexion and extension of trunk in angle, flexion and extension of hip in angle, flexion and extension of knee in angle, flexion and extension of ankle in angle, flexion and extension of shoulder in angle, abduction of shoulder in angle, flexion and extension of elbow in angle. All these angles variables will be measure in right and left limbs.; Flexion and extension of shoulder in angle, abduction of shoulder in angle will be aggregated to flexion and extension of elbow in angle to arrive at asymmetry of upper limbs in angles.; Maximum flexion and extension angles of trunk, hip, knee, ankle, shoulder and elbow; Maximum and minimum abduction of shoulder.; Range of motion of the trunk (in the sagittal plane) and pelvic and scapular (in the transverse plane) girdle.	Change from baseline at 12 weeks.
Other	Body Composition - Bone mineral density.	The body composition of the patient will be analyzed using the dual-energy X-ray absorptiometry (DEXA - Lunar Prodigy GE model Medical System, Milwaukee, WI, USA).; The patient will be lying down in the 10 to 12 minutes until the test is complete. To prevent the movement of the lower limbs during passage of the reading rod of the velcro around the ankles and thighs. The patient can wear normal clothes as long as they have no metal charges or attachments.	Change from baseline at 12 weeks.
Other	Psychological parameters - Profile of Mood State	Profile of Mood States: This variable will be measure by the Brunel Mood Scale (BRUMS) that was developed to provide a quick assessment of mood states adult populations. The BRUMS has been demonstrated to have Cronbach alpha values above 0.70 and is a reliable tool used to measure the mood of Brazilian athletes. The instrument consisted of 24 items and six subscales assessing mood: tension, depression, anger, vigor, fatigue and confusion. Each item was rated on a Likert scale ranging from nothing (0) to extremely (4), where the respondent indicated how they were feeling at that moment. The results were calculated using the mean of the items in each subscale.	Change from baseline at 12 weeks.
Other	Quality of sleep - The Pittsburgh Sleep Quality Index	The Pittsburgh Sleep Quality Index (PSQI). The PSQI consists of 24 questions or items to be rated (0-3 for 20 items while 4 items are open-ended), 19 of which are self-reported and 5 of which require secondary feedback from a room or bed partner. Only the self-reported items (15 rated as 0-3 while 4 open-ended) are used for quantitative evaluation of sleep quality as perceived by the patient. The open-ended items are also finally scored as structured categorical values (rated at 0-3) as per the range of values reported for them by the patient. These 19 self-reported items are used to generate categorical scores representing the PSQI's 7 components. The individual component scores each assess a specific feature of sleep. Finally, the scores for each component are summed to get a total score, also termed the global score (range: 0 to 21). This score provides a summary of the respondent's sleep experience and quality for the past month.	Change from baseline at 12 weeks.
Other	Nominal verbal fluency	Nominal verbal fluency evaluates verbal fluency, executive function, language, and semantic memory. The test consists in naming the largest number of words beginning with the letters "F", "A" and "S" in one minute each, excluding proper names.	Change from baseline at 12 weeks.
Primary	Test Timed Up and Go	Test Timed Up and Go This teste evaluate the mobility functional in three meters of self-selected speed (TUGSS) or at forced speed (TUGFS).	Change from baseline at 12 weeks.
Secondary	Locomotor Rehabilitation Index	The Locomotor Rehabilitation Index (LRI) is a method of determining how close is the self-selected walking speed compared to the Optimum Speed. The results is given in %, and when LRI value is closer to 100 %, it indicates that the participants are closer to their theoretical optimal walking speed.	Change from baseline at 12 weeks.
Secondary	Self-selected walking speed	SSWS This outcome will be measure in test of walking treadmill.	Change from baseline at 12 weeks.
Secondary	Optimal Walking Speed (OPT)	This outcome will be measure through of the registered image movement analysis using the three-dimensional motion analysis system (VICON) of the walking test on treadmill.	Change from baseline at 12 weeks.
Secondary	Quality of life (QoL): PDQ-39	The quality of life will be measured by the Parkinson's Disease Questionnaire, with 39 questions (PDQ-39). PDQ-39 is a PD specific health status questionnaire comprising 39 items. Respondents are requested to affirm one of five ordered response categories according to how often, due to their PD, they have experienced the problem defined by each item. The total scores are ranging between 0 and 100 points, that a lower score represents a greater perception of quality of life.	Change from baseline at 12 weeks.
Secondary	Cognitive function - Montreal Cognitive Assessment	Montreal Cognitive Assessment (MoCA) is a brief screening tool for mild cognitive impairment. This evaluation accesses different cognitive domains and investigates the individual's abilities in the following areas: attention and concentration, executive functions, memory, language, visuoconstructive skills, conceptualization, calculation and orientation. The total score of the MoCA is 30 points, with a score of 26, or more, considered normal and less than 26 is considered cognitive impairment.	Change from baseline at 12 weeks.
Secondary	Cognitive function - Mini Mental State Examination	Mini-Mental State Examination (MMSE) is a screening tool, used to identify dementia, which provides information on different cognitive parameters, containing questions grouped into seven categories that assess specific cognitive functions: temporal orientation, spatial orientation, three word registration, attention and calculation, recall of three words, language and visual constructive ability. The MMSE score can range from zero to 30 points, in which a lower score indicates a higher degree of cognitive impairment.	Change from baseline at 12 weeks.
Secondary	Depressive symptoms	This outcome will be measure for the Geriatric Depression Scale - 15 item. The scale consists of 15 dichotomous questions in which participants are asked to answer yes or no in reference to how they felt over the past week (for instance, "Do the pacient feel that their life is empty?," Do the patient feel that their situation is hopeless?). Scores range from 0 to 15 with higher scores indicating more depressive symptoms.	Change from baseline at 12 weeks.