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Effects of Nordic Walking in Parkinson Disease Patients (Walking)

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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

Tracking Information
First Submitted Date  ICMJE November 10, 2017
First Posted Date  ICMJE November 28, 2017
Last Update Posted Date November 28, 2017
Actual Study Start Date  ICMJE March 20, 2013
Actual Primary Completion Date June 30, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2017)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2017)
  • 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).
  • Self-selected walking speed - SSWS [ Time Frame: Change from baseline at 9 weeks ]
    This outcome will be measure in test of walking treadmill
  • 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.
  • 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).
  • Cognitive function [ Time Frame: Change from baseline at 9 weeks ]
    This outcome will be measure for Montreal Cognitive Assessment (MoCA).
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 21, 2017)
  • 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).
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effects of Nordic Walking in Parkinson Disease Patients
Official Title  ICMJE Effects of Nordic Walking Training on Functional, Clinical and Biomechanics Parameters in Parkinson's Disease: a Randomized Controlled Clinical Trial
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).

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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Parkinson Disease
  • Parkinson Disease 10
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Other: Nordic Walking
    • Other: Free Walking
  • 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.
    Interventions:
    • Other: Nordic Walking
    • Other: Free Walking
Publications * Monteiro EP, Franzoni LT, Cubillos DM, de Oliveira Fagundes A, Carvalho AR, Oliveira HB, Pantoja PD, Schuch FB, Rieder CR, Martinez FG, Peyré-Tartaruga LA. Effects of Nordic walking training on functional parameters in Parkinson's disease: a randomized controlled clinical trial. Scand J Med Sci Sports. 2017 Mar;27(3):351-358. doi: 10.1111/sms.12652. Epub 2016 Feb 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 21, 2017)
33
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 30, 2014
Actual Primary Completion Date June 30, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).

-

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%.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03355521
Other Study ID Numbers  ICMJE emonteiro
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Leonardo A. Peyré-Tartaruga, Federal University of Rio Grande do Sul
Study Sponsor  ICMJE Federal University of Rio Grande do Sul
Collaborators  ICMJE
  • Federal University of Health Science of Porto Alegre
  • Hospital de Clinicas de Porto Alegre
Investigators  ICMJE
Study Director: Leonardo A Peyré-Tartaruga, PhD Federal University of Rio Grande do Sul
PRS Account Federal University of Rio Grande do Sul
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP