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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03096964
Other study ID # LTartaruga,
Secondary ID
Status Completed
Phase N/A
First received December 8, 2016
Last updated March 24, 2017
Start date March 2014
Est. completion date December 2016

Study information

Verified date March 2017
Source Federal University of Rio Grande do Sul
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date December 2016
Est. primary completion date October 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Brazil Federal University of Rio Grande do Sul Porto Alegre Rio Grande do Sul

Sponsors (1)

Lead Sponsor Collaborator
Federal University of Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Self-selected walking speed - SSWS 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 Quality of life (QoL) 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
Secondary Locomotor rehabilitation index (LRI) 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
Secondary Oxygen consumption (VO2) 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
Secondary Cost of transport (C) 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
Secondary 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 (unit in km/h) from baseline to 8 weeks
Secondary Oxygen Consumption at anaerobic threshold (VO2VT2) This outcome will be measure through maximal progressive treadmill test, using the portable gas analyser VO2000 equipment. from baseline to 8 weeks
Secondary Peak Oxygen Consumption (VO2peak) This outcome will be measure through maximal progressive treadmill test, using the portable gas analyser VO2000 equipment. from baseline to 8 weeks
Secondary Heart Rate at anaerobic threshold (HRVT2) This outcome will be measure through maximal progressive treadmill test, using a heart rate monitor (POLAR, FT1). from baseline to 8 weeks
Secondary Rest Heart Rate (HRrest) 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
Secondary Exercise Heart Rate (HRexercise) 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
Secondary Rest Arterial Systolic Blood Pressure (SBPrest) 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
Secondary Rest Arterial Diastolic Blood Pressure (DBPrest) 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
Secondary Parameters of Static balance (Amplitude ans Speed of Center of pressure in X, Y and Z axis) This outcome will be measure through of Static Balance in Force Platform (AMTI) Change from baseline Parameters of Static Balance at 8 weeks
Secondary Parameters of Dynamic variability (coefficient of variation (CoV) of Stride length (SL), stride frequency (SF), swing time (ST), and contact time (CT) 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
Secondary Spatial Temporal Parameters (stride frequency, stride length, swing time and contact time) 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
Secondary Parameters of Pendular Mechanism (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 (1,2,3,4 and 5 km/h), 5 minutes at each speed. Change from baseline Parameters of Mechanical Work at 8 weeks
Secondary Other Parameters of Pendular Mechanism (Percentage of congruity (%Cong), instantaneous pendular transduction and Recovery of step, shift phase (PhaseShift). 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
Secondary Movement Body Center of Mass (BCoM) on X, Y, Z axis 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
Secondary 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) 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
Secondary 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) 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
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