- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03096964
Nordic Walking Training for Older People (Pole walking)
March 24, 2017 updated by: Leonardo A. Peyré-Tartaruga, Federal University of Rio Grande do Sul
Effects of Nordic Walking Training in Energetic, Mechanical and Neuromuscular Parameters of Elderly. A Randomized Clinical Trail
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brazil, 90690-200
- Federal University of Rio Grande do Sul
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Change from baseline SSWS at 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Change from baseline QoL at 8 weeks
|
|
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).
|
Change from baseline LRI at 8 weeks
|
|
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).
|
from baseline to 8 weeks
|
|
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).
|
from baseline to 8 weeks
|
|
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)
|
from baseline to 8 weeks
|
|
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.
|
from baseline to 8 weeks
|
|
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.
|
from baseline to 8 weeks
|
|
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).
|
from baseline to 8 weeks
|
|
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.
|
from baseline to 8 weeks
|
|
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.
|
from baseline to 8 weeks
|
|
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.
|
from baseline to 8 weeks
|
|
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.
|
Change from baseline DBPrest at 8 weeks
|
|
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)
|
Change from baseline Parameters of Static Balance at 8 weeks
|
|
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).
|
Change from baseline Parameters of Dynamic Balance at 8 weeks
|
|
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.
|
Change from baseline Spatial Temporal parameters at 8 weeks
|
|
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.
|
Change from baseline Parameters of Mechanical Work at 8 weeks
|
|
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.
|
Change from baseline other Parameters of Pendular Mechanism at 8 weeks
|
|
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.
|
Change from baseline of BCoM at 8 weeks
|
|
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
|
Change from baseline MVC at 8 weeks
|
|
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
|
Change from baseline Electromyographic parameters at 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Leonardo A Peyré-Tartaruga, PhD, PhD student of the Federal University of Rio Grande do Sul- Brasil
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Gomenuka NA, Oliveira HB, da Silva ES, Passos-Monteiro E, da Rosa RG, Carvalho AR, Costa RR, Rodriguez Paz MC, Pellegrini B, Peyre-Tartaruga LA. Nordic walking training in elderly, a randomized clinical trial. Part II: Biomechanical and metabolic adaptations. Sports Med Open. 2020 Jan 13;6(1):3. doi: 10.1186/s40798-019-0228-6.
- Gomenuka NA, Oliveira HB, Silva ES, Costa RR, Kanitz AC, Liedtke GV, Schuch FB, Peyre-Tartaruga LA. Effects of Nordic walking training on quality of life, balance and functional mobility in elderly: A randomized clinical trial. PLoS One. 2019 Jan 30;14(1):e0211472. doi: 10.1371/journal.pone.0211472. eCollection 2019.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2014
Primary Completion (Actual)
October 1, 2014
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
December 8, 2016
First Submitted That Met QC Criteria
March 24, 2017
First Posted (Actual)
March 31, 2017
Study Record Updates
Last Update Posted (Actual)
March 31, 2017
Last Update Submitted That Met QC Criteria
March 24, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- LTartaruga,
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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