Parkinson DiseaseNCT03860649

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

A study testing Nordic Walking, Jogging and Dance in people with Parkinson Disease and Parkinson Disease 10, run by Federal University of Rio Grande do Sul at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

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… Read more about this study

Who is it for?: Ages 40 to 80 years
Conditions the study is for: Parkinson Disease, Parkinson Disease 10
What is being tested?: Nordic Walking, Jogging and Dance
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteBrazil
Study dates: 1 Aug 2018to 30 Dec 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Federal University of Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90690200

Other trials in Brazil

About this study

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

Read the detailed 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).

Conditions: Parkinson Disease, Parkinson Disease 10
Being tested: Nordic Walking, Jogging, Dance, Pilates Training
Keywords: Mobility, Functionality, Movement disorders, Rehabilitation, Locomotion
Medical subject headings: Parkinson Disease, Parkinson Disease 10, Movement Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nordic WalkingOther
24 sessions will be held twice a week, with each session taking an average of 60 minutes.
JoggingOther
24 sessions will be held twice a week, with each session taking an average of 60 minutes.
DanceOther
24 sessions will be held twice a week, with each session taking an average of 60 minutes.
Pilates TrainingOther
24 sessions will be held twice a week, with each session taking an average of 60 minutes.

Study groups in NCT03860649
Study group	Role	What they receive
Nordic Walking	Experimental	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. Receives: Other: Nordic Walking
Jogging	Experimental	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. Receives: Other: Jogging
Dance	Experimental	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. Receives: Other: Dance
Pilates Training	Experimental	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. Receives: Other: Pilates Training

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: Change from baseline at 12 weeks.

Secondary outcomes (7)

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.
Measured: Change from baseline at 12 weeks.
Self-selected walking speed
SSWS This outcome will be measure in test of walking treadmill.
Measured: Change from baseline at 12 weeks.
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.
Measured: Change from baseline at 12 weeks.
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.
Measured: Change from baseline at 12 weeks.
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.
Measured: Change from baseline at 12 weeks.
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.
Measured: Change from baseline at 12 weeks.
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.
Measured: Change from baseline at 12 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 201830 Dec 2022

First posted4 Mar 2019
Study start1 Aug 2018
Primary completion30 Jul 2019
Study completion30 Dec 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (34)Papers the sponsor has linked to this study.
Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03860649
Sponsor's protocol ID: LTartaruga,PPT-Parkinson
Status last verified: Jun 2020
First submitted: 5 Dec 2018
Last updated: 9 Jun 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Alberts JL, Linder SM, Penko AL, Lowe MJ, Phillips M. It is not about the bike, it is about the pedaling: forced exercise and Parkinson's disease. Exerc Sport Sci Rev. 2011 Oct;39(4):177-86. doi: 10.1097/JES.0b013e31822cc71a.
PubMed 21799425
Cavagna GA, Willems PA, Legramandi MA, Heglund NC. Pendular energy transduction within the step in human walking. J Exp Biol. 2002 Nov;205(Pt 21):3413-22. doi: 10.1242/jeb.205.21.3413.
PubMed 12324550
Cho C, Kunin M, Kudo K, Osaki Y, Olanow CW, Cohen B, Raphan T. Frequency-velocity mismatch: a fundamental abnormality in parkinsonian gait. J Neurophysiol. 2010 Mar;103(3):1478-89. doi: 10.1152/jn.00664.2009. Epub 2009 Dec 30.
PubMed 20042701
Dereli EE, Yaliman A. Comparison of the effects of a physiotherapist-supervised exercise programme and a self-supervised exercise programme on quality of life in patients with Parkinson's disease. Clin Rehabil. 2010 Apr;24(4):352-62. doi: 10.1177/0269215509358933.
PubMed 20360152
Detrembleur C, van den Hecke A, Dierick F. Motion of the body centre of gravity as a summary indicator of the mechanics of human pathological gait. Gait Posture. 2000 Dec;12(3):243-50. doi: 10.1016/s0966-6362(00)00081-3.
PubMed 11154935
Farris DJ, Hampton A, Lewek MD, Sawicki GS. Revisiting the mechanics and energetics of walking in individuals with chronic hemiparesis following stroke: from individual limbs to lower limb joints. J Neuroeng Rehabil. 2015 Feb 27;12:24. doi: 10.1186/s12984-015-0012-x.
PubMed 25889030
Franchignoni F, Horak F, Godi M, Nardone A, Giordano A. Using psychometric techniques to improve the Balance Evaluation Systems Test: the mini-BESTest. J Rehabil Med. 2010 Apr;42(4):323-31. doi: 10.2340/16501977-0537.
PubMed 20461334
Frazzitta G, Balbi P, Maestri R, Bertotti G, Boveri N, Pezzoli G. The beneficial role of intensive exercise on Parkinson disease progression. Am J Phys Med Rehabil. 2013 Jun;92(6):523-32. doi: 10.1097/PHM.0b013e31828cd254.
PubMed 23552330
Gallo PM, McIsaac TL, Garber CE. Walking economy during cued versus non-cued self-selected treadmill walking in persons with Parkinson's disease. J Parkinsons Dis. 2014;4(4):705-16. doi: 10.3233/JPD-140445.
PubMed 25261459
Gomenuka NA, Bona RL, da Rosa RG, Peyre-Tartaruga LA. The pendular mechanism does not determine the optimal speed of loaded walking on gradients. Hum Mov Sci. 2016 Jun;47:175-185. doi: 10.1016/j.humov.2016.03.008. Epub 2016 Mar 24.
PubMed 27017543
Hackney ME, Kantorovich S, Levin R, Earhart GM. Effects of tango on functional mobility in Parkinson's disease: a preliminary study. J Neurol Phys Ther. 2007 Dec;31(4):173-9. doi: 10.1097/NPT.0b013e31815ce78b.
PubMed 18172414
Hausdorff JM, Schaafsma JD, Balash Y, Bartels AL, Gurevich T, Giladi N. Impaired regulation of stride variability in Parkinson's disease subjects with freezing of gait. Exp Brain Res. 2003 Mar;149(2):187-94. doi: 10.1007/s00221-002-1354-8. Epub 2003 Jan 22.
PubMed 12610686
Herman T, Giladi N, Gruendlinger L, Hausdorff JM. Six weeks of intensive treadmill training improves gait and quality of life in patients with Parkinson's disease: a pilot study. Arch Phys Med Rehabil. 2007 Sep;88(9):1154-8. doi: 10.1016/j.apmr.2007.05.015.
PubMed 17826461
Hoehn MM, Yahr MD. Parkinsonism: onset, progression and mortality. Neurology. 1967 May;17(5):427-42. doi: 10.1212/wnl.17.5.427. No abstract available.
PubMed 6067254
Jankovic J. Parkinson's disease: clinical features and diagnosis. J Neurol Neurosurg Psychiatry. 2008 Apr;79(4):368-76. doi: 10.1136/jnnp.2007.131045.
PubMed 18344392

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03860649
Acronym / sponsor ID: LTartaruga,PPT-Parkinson
Conditions: Parkinson Disease, Parkinson Disease 10
Keywords: Mobility, Functionality, Movement disorders, Rehabilitation, Locomotion
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 100 participants (actual)
Lead sponsor: Federal University of Rio Grande do SulUniversity, hospital or other
Collaborators: Aline Nogueira Haas, Flávia Gomes Martinez
Study start: 1 Aug 2018 (actual)
Primary completion: 30 Jul 2019 (actual)
Study completion: 30 Dec 2022 (estimated)
First posted: 4 Mar 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Nordic Walking	Experimental	Other: Nordic WalkingThe 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.
Jogging	Experimental	Other: JoggingThis 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.
Dance	Experimental	Other: DanceThis 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.
Pilates Training	Experimental	Other: Pilates TrainingClasses 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.

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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).

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Nordic Walking24 sessions will be held twice a week, with each session taking an average of 60 minutes.	Other	Nordic Walking
Jogging24 sessions will be held twice a week, with each session taking an average of 60 minutes.	Other	Jogging
Dance24 sessions will be held twice a week, with each session taking an average of 60 minutes.	Other	Dance
Pilates Training24 sessions will be held twice a week, with each session taking an average of 60 minutes.	Other	Pilates Training

Primary outcome

Test Timed Up and Go
Time frame: Change from baseline at 12 weeks.
Test Timed Up and Go This teste evaluate the mobility functional in three meters of self-selected speed (TUGSS) or at forced speed (TUGFS).

7 secondary outcomes

Locomotor Rehabilitation Index
Time frame: Change from baseline at 12 weeks.
Self-selected walking speed
Time frame: Change from baseline at 12 weeks.
Optimal Walking Speed (OPT)
Time frame: Change from baseline at 12 weeks.
Quality of life (QoL): PDQ-39
Time frame: Change from baseline at 12 weeks.
Cognitive function - Montreal Cognitive Assessment
Time frame: Change from baseline at 12 weeks.
Cognitive function - Mini Mental State Examination
Time frame: Change from baseline at 12 weeks.
Depressive symptoms
Time frame: Change from baseline at 12 weeks.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
Background: PubMed 21799425Alberts JL, Linder SM, Penko AL, Lowe MJ, Phillips M. It is not about the bike, it is about the pedaling: forced exercise and Parkinson's disease. Exerc Sport Sci Rev. 2011 Oct;39(4):177-86. doi: 10.1097/JES.0b013e31822cc71a.
Background: PubMed 12324550Cavagna GA, Willems PA, Legramandi MA, Heglund NC. Pendular energy transduction within the step in human walking. J Exp Biol. 2002 Nov;205(Pt 21):3413-22. doi: 10.1242/jeb.205.21.3413.
Background: PubMed 20042701Cho C, Kunin M, Kudo K, Osaki Y, Olanow CW, Cohen B, Raphan T. Frequency-velocity mismatch: a fundamental abnormality in parkinsonian gait. J Neurophysiol. 2010 Mar;103(3):1478-89. doi: 10.1152/jn.00664.2009. Epub 2009 Dec 30.
Background: PubMed 20360152Dereli EE, Yaliman A. Comparison of the effects of a physiotherapist-supervised exercise programme and a self-supervised exercise programme on quality of life in patients with Parkinson's disease. Clin Rehabil. 2010 Apr;24(4):352-62. doi: 10.1177/0269215509358933.
Background: PubMed 11154935Detrembleur C, van den Hecke A, Dierick F. Motion of the body centre of gravity as a summary indicator of the mechanics of human pathological gait. Gait Posture. 2000 Dec;12(3):243-50. doi: 10.1016/s0966-6362(00)00081-3.
Background: PubMed 25889030Farris DJ, Hampton A, Lewek MD, Sawicki GS. Revisiting the mechanics and energetics of walking in individuals with chronic hemiparesis following stroke: from individual limbs to lower limb joints. J Neuroeng Rehabil. 2015 Feb 27;12:24. doi: 10.1186/s12984-015-0012-x.
Background: PubMed 20461334Franchignoni F, Horak F, Godi M, Nardone A, Giordano A. Using psychometric techniques to improve the Balance Evaluation Systems Test: the mini-BESTest. J Rehabil Med. 2010 Apr;42(4):323-31. doi: 10.2340/16501977-0537.
Background: PubMed 23552330Frazzitta G, Balbi P, Maestri R, Bertotti G, Boveri N, Pezzoli G. The beneficial role of intensive exercise on Parkinson disease progression. Am J Phys Med Rehabil. 2013 Jun;92(6):523-32. doi: 10.1097/PHM.0b013e31828cd254.
Background: PubMed 25261459Gallo PM, McIsaac TL, Garber CE. Walking economy during cued versus non-cued self-selected treadmill walking in persons with Parkinson's disease. J Parkinsons Dis. 2014;4(4):705-16. doi: 10.3233/JPD-140445.
Background: PubMed 27017543Gomenuka NA, Bona RL, da Rosa RG, Peyre-Tartaruga LA. The pendular mechanism does not determine the optimal speed of loaded walking on gradients. Hum Mov Sci. 2016 Jun;47:175-185. doi: 10.1016/j.humov.2016.03.008. Epub 2016 Mar 24.
Background: PubMed 18172414Hackney ME, Kantorovich S, Levin R, Earhart GM. Effects of tango on functional mobility in Parkinson's disease: a preliminary study. J Neurol Phys Ther. 2007 Dec;31(4):173-9. doi: 10.1097/NPT.0b013e31815ce78b.
Background: PubMed 12610686Hausdorff JM, Schaafsma JD, Balash Y, Bartels AL, Gurevich T, Giladi N. Impaired regulation of stride variability in Parkinson's disease subjects with freezing of gait. Exp Brain Res. 2003 Mar;149(2):187-94. doi: 10.1007/s00221-002-1354-8. Epub 2003 Jan 22.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Leonardo Alexandre Peyré-Tartaruga, PhD study director

Federal University of Rio Grande do Sul

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Nordic Walking, Jogging and Dance in people with Parkinson Disease and Parkinson Disease 10, run by Federal University of Rio Grande do Sul at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Test Timed Up and Go (time frame: Change from baseline at 12 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03860649, which also lists 34 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.