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Nordic Walking Training for Older People (Pole 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: NCT03096964
Recruitment Status : Completed
First Posted : March 31, 2017
Last Update Posted : March 31, 2017
Sponsor:
Information provided by (Responsible Party):
Leonardo A. Peyré-Tartaruga, Federal University of Rio Grande do Sul

Tracking Information
First Submitted Date  ICMJE December 8, 2016
First Posted Date  ICMJE March 31, 2017
Last Update Posted Date March 31, 2017
Study Start Date  ICMJE March 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2017)
Self-selected walking speed - SSWS [ Time Frame: Change from baseline SSWS at 8 weeks ]
This outcome will be measure through sub-maximal test of walking treadmill, using the portable gas analyser Equipment.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2017)
  • Quality of life (QoL) [ Time Frame: Change from baseline QoL at 8 weeks ]
    The quality of life will be estimated using the World Health Organization Quality of Life Project for elderly people (WHOQOL) instrument.
  • Locomotor rehabilitation index (LRI) [ Time Frame: Change from baseline LRI at 8 weeks ]
    This outcome will be measure through of the measure on sub-maximal test of walking treadmill, using the three-dimensional motion analysis system (VICON).
  • Oxygen consumption (VO2) [ Time Frame: from baseline to 8 weeks ]
    This outcome will be measure through of the of the walking test on treadmill and too using the portable gas analyzer equipment (units in ml/kg/min).
  • Cost of transport (C) [ Time Frame: from baseline to 8 weeks ]
    This outcome will be measured through of the walking test on a treadmill will be collected the oxigem consumption using the portable gas analyzer equipment (measure unit in ml.O2.km).
  • Optimal Walking Speed (OPT) [ Time Frame: from baseline to 8 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 (unit in km/h)
  • Oxygen Consumption at anaerobic threshold (VO2VT2) [ Time Frame: from baseline to 8 weeks ]
    This outcome will be measure through maximal progressive treadmill test, using the portable gas analyser VO2000 equipment.
  • Peak Oxygen Consumption (VO2peak) [ Time Frame: from baseline to 8 weeks ]
    This outcome will be measure through maximal progressive treadmill test, using the portable gas analyser VO2000 equipment.
  • Heart Rate at anaerobic threshold (HRVT2) [ Time Frame: from baseline to 8 weeks ]
    This outcome will be measure through maximal progressive treadmill test, using a heart rate monitor (POLAR, FT1).
  • Rest Heart Rate (HRrest) [ Time Frame: from baseline to 8 weeks ]
    This outcome will be measure using a heart rate monitor (POLAR, FT1). The participants will remain seated in a quiet and controlled temperature room during 15 minutes prior to measurement of the heart rate.
  • Exercise Heart Rate (HRexercise) [ Time Frame: from baseline to 8 weeks ]
    This outcome will be measure using a heart rate monitor (POLAR, FT1) measurement of the heart rate of exercise during the walking test on treadmill at different speed.
  • Rest Arterial Systolic Blood Pressure (SBPrest) [ Time Frame: from baseline to 8 weeks ]
    This outcome will be measured through blood pressure ambulatory monitor (Meditech). The participants will remain seated in a quiet and controlled temperature room during 15 minutes prior to measurement of the arterial systolic blood pressure.
  • Rest Arterial Diastolic Blood Pressure (DBPrest) [ Time Frame: Change from baseline DBPrest at 8 weeks ]
    This outcome will be measured through blood pressure ambulatory monitor (Meditech, ABPM-04 equipment). The participants will remain seated in a quiet and controlled temperature room during 15 minutes prior to measurement of the arterial systolic blood pressure.
  • Parameters of Static balance (Amplitude ans Speed of Center of pressure in X, Y and Z axis) [ Time Frame: Change from baseline Parameters of Static Balance at 8 weeks ]
    This outcome will be measure through of Static Balance in Force Platform (AMTI)
  • Parameters of Dynamic variability (coefficient of variation (CoV) of Stride length (SL), stride frequency (SF), swing time (ST), and contact time (CT) [ Time Frame: Change from baseline Parameters of Dynamic Balance at 8 weeks ]
    This outcome will be measure through of the variability on sub-maximal test of walking treadmill, using the three-dimensional motion analysis system (VICON).
  • Spatial Temporal Parameters (stride frequency, stride length, swing time and contact time) [ Time Frame: Change from baseline Spatial Temporal parameters at 8 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 at different speed of walking (1,2,3,4 and 5 km/h), 5 minutes at each speed.
  • Parameters of Pendular Mechanism (external, internal and total mechanical work, Wext, Wint and Wtot, respectively, Recovery). [ Time Frame: Change from baseline Parameters of Mechanical Work at 8 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 at different speed of walking (1,2,3,4 and 5 km/h), 5 minutes at each speed.
  • Other Parameters of Pendular Mechanism (Percentage of congruity (%Cong), instantaneous pendular transduction and Recovery of step, shift phase (PhaseShift). [ Time Frame: Change from baseline other Parameters of Pendular Mechanism at 8 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 at different speed of walking (1,2,3,4 and 5 km/h), 5 minutes at each speed.
  • Movement Body Center of Mass (BCoM) on X, Y, Z axis [ Time Frame: Change from baseline of BCoM at 8 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 at different speed of walking (1,2,3,4 and 5 km/h), 5 minutes at each speed.
  • Maximal voluntary contractions (MVC) of the muscles: anterior deltoid (AD), triceps brachii (TB), vastus lateralis (VL), biceps femoris (BF), anterior tibial (AT) and medial gastrocnemius (MG) [ Time Frame: Change from baseline MVC at 8 weeks ]
    This outcome will be measured through Measuring the electromyographic activation during treadmill walking tests using the Miotool electromyograph
  • Electromyographic Parameters (mean amplitude of the signal and co-contraction) of the muscles: anterior deltoid (AD), triceps brachii (TB), vastus lateralis (VL), biceps femoris (BF), anterior tibial (AT) and medial gastrocnemius (MG) [ Time Frame: Change from baseline Electromyographic parameters at 8 weeks ]
    This outcome will be measured through Measuring the electromyographic activation during treadmill walking tests using an electromyograph
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nordic Walking Training for Older People
Official Title  ICMJE Effects of Nordic Walking Training in Energetic, Mechanical and Neuromuscular Parameters of Elderly. A Randomized Clinical Trail
Brief Summary Objective: to assess by means of a randomized clinical trial the effects of eight weeks of Nordic walking and free walking training on quality of life (QoL), static balance, dynamic variability, self-selected walking speed (SWS) and locomotor rehabilitation index (LRI), parameters of pendular mechanism [external (Wext), internal (Wint) and total mechanical work (Wtot), Recovery (R), Cost of Transport (C)], Electromyographic parameters (Average signal and co-contraction of the Anterior deltoid (AD), triceps brachii (TB), vastus lateralis (VL), biceps femoris (BF), anterior tibial (AT) and medial gastrocnemius (MG) muscles, heart rate of exercise (HRexercise) - and the rate of perceived exertion (RPE), in sedentary elderly.
Detailed Description Introduction: Considering the increase in the elderly population and their life expectancy, together with the expansion of Nordic walking (NW) interventions as a training method for the elderly, there is a need of preventive studies of RCTs and with methodological good quality approach to enable physical education, health and rehabilitation professionals to make decisions regarding the type, the volume and the intensity of NW exercise in promoting the health of the sedentary elderly. Objectives: The aim of this study is to evaluate, through a randomized clinical trial, the effects of eight weeks of NW and FW training on quality of life (QoL), static balance, dynamic variability, self-selected treadmill walking speed (SSWSTreadmill), Locomotor rehabilitation (LRI) Parameters of Pendular Mechanism (external, internal and total mechanical work -Wext, Wint, Wtot, Recovery -R,Cost of Transport - C), Electromyographic parameters (Average signal and co-contraction of the AD, TB, VL, BF, AT and MG muscles), heart rate of exercise - HRexercise and the rate of perceived exertion (RPE), in sedentary elderly. of sedentary elderly. Experimental Design: Randomized Controlled Clinical Trial (RCT). Study Site: School of Physical Education, Physiotherapy and Dance (ESEFID), Federal University of Rio Grande do Sul Porto Alegre, Rio Grande do Sul, Brazil. Methods: The sample comprised 33 sedentary participants randomly divided into two groups (Nordic walking group and Free walking group who will perform training for 8 weeks.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Sedentary Lifestyle
  • Age Problems
Intervention  ICMJE
  • Other: Free walking training
    The training period begin for both groups, will be comprised of eight weeks of duration, with frequency of three weekly sessions. Volume (session duration in minutes) and intensity (percentage of the heart rate at second threshold ) were the same for both groups, only differing in the use (NW) or not of the poles (FW). Each session will have of the Initial Part or warming-up, the Main Part and Final Part or cooling-down.
  • Other: Nordic walking training
    The training period begin for both groups, will be comprised of eight weeks of duration, with frequency of three weekly sessions. Volume (session duration in minutes) and intensity (percentage of the heart rate at second threshold ) were the same for both groups, only differing in the use (NW) or not of the poles (FW). Each session will have of the Initial Part or warming-up, the Main Part and Final Part or cooling-down.
Study Arms  ICMJE
  • Experimental: Nordic walking
    Experimental: Nordic walking Training The total period of training was composed by 8-week of walking with poles, three sessions per week. The cycles were divided into eight microcycles composed by three training sessions. Each training session took 60 min. Nordic walking aerobics training were used during the training period. These exercises were performed alternating volume and intensity. Exercise intensities were controlled using the cardiac monitor, and the zone was since 70% to 105% of the heart rate at the second ventilatory threshold. And volume was controlled using the time of the session.
    Intervention: Other: Nordic walking training
  • Experimental: Free Walking
    Experimental: Free walking Training The total period of training was composed by a 8-week cycles of walking without poles, with three sessions per week. The cycles were divided into eight microcycles composed by three training sessions. Each training session took 60 min. Free walking aerobics training were used during the training period. These exercises were performed alternating volume and intensity. Exercise intensities were controlled using the cardiac monitor, and the zone was since 70% to 105% of the heart rate at the second ventilatory threshold. And volume was controlled using the time of the session.
    Intervention: Other: Free walking training
Publications *

*   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: March 24, 2017)
32
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Sedentary elderly people
  • Aged between 60 and 80

Exclusion Criteria:

  • Smoking
  • Show chronic pain or presence of migraine or nausea in daily life;
  • History of labyrinthitis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT03096964
Other Study ID Numbers  ICMJE LTartaruga,
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
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 Not Provided
Investigators  ICMJE
Principal Investigator: Leonardo A Peyré-Tartaruga, PhD PhD student of the Federal University of Rio Grande do Sul- Brasil
PRS Account Federal University of Rio Grande do Sul
Verification Date March 2017

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