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Effects of Nordic Walking in Parkinson Disease Patients (Walking)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03355521
Recruitment Status : Completed
First Posted : November 28, 2017
Last Update Posted : November 28, 2017
Sponsor:
Collaborators:
Federal University of Health Science of Porto Alegre
Hospital de Clinicas de Porto Alegre
Information provided by (Responsible Party):
Leonardo A. Peyré-Tartaruga, Federal University of Rio Grande do Sul

Brief Summary:

The aim of this study was to evaluate and compare the effects of a Nordic and free walking training program on clinical, functional and biomechanical parameters of gait, in people with PD.

Outcomes: Motor symptoms: Staging and severity of PD, balance, walking functional mobility, self-selected walking velocity, and rehabilitation index. Non-Motor symptoms: Cognitive function, depressive symptoms, and quality of life (QL). Outcomes Biomechanics: Kinematic parameters (spatiotemporal and dynamic stability of walking) and neuromuscular parameters (amplitude of the electromyography signal, initial and final activation threshold, activation time and co-contraction index, of the following muscles: Vastus Lateralis (VL), Biceps Femoris (BF), Tibialis Anterior (TA), Gastrocnemius Medialis (GM).


Condition or disease Intervention/treatment Phase
Parkinson Disease Parkinson Disease 10 Other: Nordic Walking Other: Free Walking Not Applicable

Detailed Description:
Introduction: Changes in clinical, functional and biomechanical parameters of gait are remarkable features in Parkinson's disease (PD). Such changes are disabling for the performance of daily living activities (DLAs) as they represent a high risk of falls and impair quality of life (QL) in this population. Although exercise is recommended as an effective model of therapeutic intervention, to minimize the symptoms of this disease, little is known about the effects of Nordic walking on motor and non-motor symptoms in patients with PD. Purpose: The aim of this study was to evaluate and compare the effects of a Nordic and free walking training program on clinical, functional and biomechanical parameters of gait, in people with PD. Experimental Design: Randomized controlled clinical trial (RCT). Study Site: Physical Education School of the Federal University of Rio Grande do Sul and the Clinical Hospital of Porto Alegre, in Porto Alegre, Rio Grande do Sul, Brazil. Methods: The sample comprised 33 participants, aged above 50 years, of both sexes, with a clinical diagnosis of idiopathic PD, with the staging of 1-4 in the Hoehn and Yahr scale (H&Y). The participants received two types of intervention: Nordic walking training program (NW, n = 16) and free walking training program (FW, n = 17), during six weeks. Aiming to evaluate the effects of the training program, the participants underwent the tests in the following period: pre-training + pre-familiarization (T1); post-familiarization + pre-training (T2); post-training (T3).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Experimental: Nordic walking Experimental: Nordic walking Training The total period of training was composed by 9-week of walking with poles, two sessions per week. The cycles were divided into four microcycles composed of three training sessions. Each training session took 60 min. Nordic walking aerobics training was used during the training period. These exercises were performed alternating volume and intensity. The training session was divided into three stages: (a) stretching, joint mobility, and heating; (b) main part (FW or NW); (c) return to the calm and ultimate stretching. The participants were trained with individualized prescription according to their maximum distance. A heart rate monitor, Model FT4 attached to the chest of the xiphoid process, was used to control the progression of intensity for the training cycles ranging from 60% to 80% of heart rate reserve. Additionally, we used the Borg RPE for training intensity control, which ranged between 13 and 17 of that scale.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Outcomes Assessor
Primary Purpose: Treatment
Official Title: Effects of Nordic Walking Training on Functional, Clinical and Biomechanics Parameters in Parkinson's Disease: a Randomized Controlled Clinical Trial
Actual Study Start Date : March 20, 2013
Actual Primary Completion Date : June 30, 2013
Actual Study Completion Date : July 30, 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nordic walking Experimental
Experimental: Nordic walking Training The total period of training was composed by 9-week of walking with poles, two sessions per week. The cycles were divided into four microcycles composed of three training sessions. Each training session took 60 min. Nordic walking aerobics training was used during the training period. These exercises were performed alternating volume and intensity. The training session was divided into three stages: (a) stretching, joint mobility, and heating; (b) main part (NW); (c) return to the calm and ultimate stretching.
Other: Nordic Walking
Nordic walking Training the total period of training was composed by 9-week of walking with poles, two sessions per week. The cycles were divided into four microcycles composed of three training sessions. Each training session took 60 min. Free walking aerobics training was used during the training period. These exercises were performed alternating volume and intensity. The training session was divided into three stages: (a) stretching, joint mobility, and heating; (b) main part (FW); (c) return to the calm and ultimate stretching.

Other: Free Walking
Free walking Training The total period of training was composed by 9-week of walking without poles, two sessions per week. The cycles were divided into four microcycles composed of three training sessions. Each training session took 60 min. Free walking aerobics training was used during the training period. These exercises were performed alternating volume and intensity. The training session was divided into three stages: (a) stretching, joint mobility, and heating; (b) main part (FW); (c) return to the calm and ultimate stretching.

Active Comparator: Free walking
Free walking Training The total period of training was composed by 9-week of walking without poles, two sessions per week. The cycles were divided into four microcycles composed of three training sessions. Each training session took 60 min. Free walking aerobics training was used during the training period. These exercises were performed alternating volume and intensity. The training session was divided into three stages: (a) stretching, joint mobility, and heating; (b) main part (FW); (c) return to the calm and ultimate stretching.
Other: Nordic Walking
Nordic walking Training the total period of training was composed by 9-week of walking with poles, two sessions per week. The cycles were divided into four microcycles composed of three training sessions. Each training session took 60 min. Free walking aerobics training was used during the training period. These exercises were performed alternating volume and intensity. The training session was divided into three stages: (a) stretching, joint mobility, and heating; (b) main part (FW); (c) return to the calm and ultimate stretching.

Other: Free Walking
Free walking Training The total period of training was composed by 9-week of walking without poles, two sessions per week. The cycles were divided into four microcycles composed of three training sessions. Each training session took 60 min. Free walking aerobics training was used during the training period. These exercises were performed alternating volume and intensity. The training session was divided into three stages: (a) stretching, joint mobility, and heating; (b) main part (FW); (c) return to the calm and ultimate stretching.




Primary Outcome Measures :
  1. Test Timed Up and Go [ Time Frame: Change from baseline at 9 weeks ]
    This teste evaluate the mobility functional in three meters of self-selected speed (TUGSS) or at forced speed (TUGFS)


Secondary Outcome Measures :
  1. Locomotor Rehabilitation Index [ Time Frame: Change from baseline at 9 weeks ]
    The Locomotor Rehabilitation Index is a method of determining how close is the SSW compared to the Optimum Speed (Vopt).

  2. Self-selected walking speed - SSWS [ Time Frame: Change from baseline at 9 weeks ]
    This outcome will be measure in test of walking treadmill

  3. Optimal Walking Speed (OPT) [ Time Frame: Change from baseline at 9 weeks ]
    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.

  4. Quality of life (QoL) [ Time Frame: Change from baseline at 9 weeks ]
    The quality of life will be estimated using the World Health Organization Quality of Life. (WHOQOL-short domains: physical, psychological, social relationships, environment, and general quality of life) and (WHOQOL-Long domains: sensory abilities, autonomy, Past. Present and Future Activities, social participation, death and dying, intimacy, and general quality of life).

  5. Cognitive function [ Time Frame: Change from baseline at 9 weeks ]
    This outcome will be measure for Montreal Cognitive Assessment (MoCA).

  6. Depressive symptoms [ Time Frame: Change from baseline at 9 weeks ]
    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 you feel that your life is empty?," Do you feel that your situation is hopeless?). Scores range from 0 to 15 with higher scores indicating more depressive symptoms.


Other Outcome Measures:
  1. Motor symptoms [ Time Frame: Change from baseline at 9 weeks ]

    This outcome will be evaluated using Unified Parkinson's Disease Rating Scale. This Scale the clinician-scored monitored motor evaluation. Will be to considered 30% improvement in the Part III score hasbeen applied to define "responders. 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).


  2. Balance Dynamics [ Time Frame: Change from baseline at 9 weeks ]
    This outcome will be evaluated using Berg Balance Scale (BBS). This scale assessment of the individual's balance in 14 situations, representative of activities of the day to day, such as: stand up, get up, walk, to lean forward, to move, to turn, among others. The maximum score of a being reached of 56 points and each item has an ordinal scale of five alternatives ranging from 0 to 4 points, according to the degree of difficulty.

  3. Balance Static [ Time Frame: Change from baseline at 9 weeks ]
    This outcome will be evaluated using area of center of pressure (cm), with average velocity (IN cm/s) and root mean square (RMS). Assessments using unique measurements with force plat.

  4. Spatial Temporal Parameters [ Time Frame: Change from baseline at 9 weeks ]
    This outcome is measure a composite for: stride frequency (in Hetz), stride length (in meters), swing time (in second) and contact time (in second). 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 at different speed of walking (SSWS, below and above of the SSWS), 3 minutes at each speed (in kilometros/hours).

  5. Dynamics Stability [ Time Frame: Change from baseline at 9 weeks ]
    This outcome will be evaluated using the coefficient of variation (CoV) of the Spatial Temporal Parameters: stride frequency (In Hertz), stride length (in meters), swing time (in seconds) and contact time(in seconds) in of the walking test on treadmill at different speed of walking (SSWS, below and above of the SSWS), 3 minutes at each speed.

  6. Anthropometric data [ Time Frame: Change from baseline at 9 weeks ]
    This outcome is a composite for: circumferences (in cm), height (in meters), body massa (in kilograms) and body mass index - BMI (weight and height will be combined to report BMI in kg/m^2. This outcome will be measure with balance, stadiometer and anthropometric tape.

  7. Electromyographic Parameters [ Time Frame: Change from baseline at 9 weeks ]
    This outcome is measure is a composite for: mean amplitude (in milivolts), onset (in seconds), offset (in seconds) and time of the signal and co-contraction (in seconds) of the muscles: vastus lateralis (VL), biceps femoris (BF), anterior tibial (AT) and medial gastrocnemius (MG) This outcome will be measured through Measuring the electromyographic activation during treadmill walking tests using an electromyograph. In of the walking test on treadmill at different speed of walking (SSWS, below and above of the SSWS), 3 minutes at each speed.

  8. Parameters of Pendular Mechanism [ Time Frame: Change from baseline at 9 weeks ]
    This outcome is measure a composite for:(external, internal and total mechanical work, Wext,Wint and Wtot, respectively, Recovery. 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 at different speed of walking (SSWS, below and above of the SSWS), 3 minutes at each speed.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: volunteers aged over 50 years, of both sexes, with a clinical diagnosis of idiopathic PD and staging between 1 and 4 in Hoehn and Yahr Scale (H&Y).

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Exclusion Criteria:

  • Show chronic pain or presence of a migraine or nausea in daily life;
  • History of labyrinthitis;
  • Deep Brain Stimulation (DBS);
  • The frequency of training below of 75%.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03355521


Locations
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Brazil
Federal University of Rio Grande do Sul
Porto Alegre, Rio Grande Do Sul, Brazil, 90690-200
Sponsors and Collaborators
Federal University of Rio Grande do Sul
Federal University of Health Science of Porto Alegre
Hospital de Clinicas de Porto Alegre
Investigators
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Study Director: Leonardo A Peyré-Tartaruga, PhD Federal University of Rio Grande do Sul
Additional Information:
Publications of Results:
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Responsible Party: Leonardo A. Peyré-Tartaruga, Adjunct Professor, Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT03355521    
Other Study ID Numbers: emonteiro
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: November 28, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Leonardo A. Peyré-Tartaruga, Federal University of Rio Grande do Sul:
functionality
gait
kinematics
electromyographic activity
depressive symptoms
quality of life
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases