- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT03096964
Nordic Walking Training for Older People (Pole walking)
24 marca 2017 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
32
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brazylia, 90690-200
- Federal University of Rio Grande do Sul
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
60 lat do 80 lat (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Tak
Płeć kwalifikująca się do nauki
Wszystko
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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.
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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.
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Eksperymentalny: 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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Self-selected walking speed - SSWS
Ramy czasowe: Change from baseline SSWS at 8 weeks
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This outcome will be measure through sub-maximal test of walking treadmill, using the portable gas analyser Equipment.
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Change from baseline SSWS at 8 weeks
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Quality of life (QoL)
Ramy czasowe: Change from baseline QoL at 8 weeks
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The quality of life will be estimated using the World Health Organization Quality of Life Project for elderly people (WHOQOL) instrument.
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Change from baseline QoL at 8 weeks
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Locomotor rehabilitation index (LRI)
Ramy czasowe: Change from baseline LRI at 8 weeks
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This outcome will be measure through of the measure on sub-maximal test of walking treadmill, using the three-dimensional motion analysis system (VICON).
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Change from baseline LRI at 8 weeks
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Oxygen consumption (VO2)
Ramy czasowe: from baseline to 8 weeks
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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).
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from baseline to 8 weeks
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Cost of transport (C)
Ramy czasowe: from baseline to 8 weeks
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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).
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from baseline to 8 weeks
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Optimal Walking Speed (OPT)
Ramy czasowe: from baseline to 8 weeks
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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)
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from baseline to 8 weeks
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Oxygen Consumption at anaerobic threshold (VO2VT2)
Ramy czasowe: from baseline to 8 weeks
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This outcome will be measure through maximal progressive treadmill test, using the portable gas analyser VO2000 equipment.
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from baseline to 8 weeks
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Peak Oxygen Consumption (VO2peak)
Ramy czasowe: from baseline to 8 weeks
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This outcome will be measure through maximal progressive treadmill test, using the portable gas analyser VO2000 equipment.
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from baseline to 8 weeks
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Heart Rate at anaerobic threshold (HRVT2)
Ramy czasowe: from baseline to 8 weeks
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This outcome will be measure through maximal progressive treadmill test, using a heart rate monitor (POLAR, FT1).
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from baseline to 8 weeks
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Rest Heart Rate (HRrest)
Ramy czasowe: from baseline to 8 weeks
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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.
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from baseline to 8 weeks
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Exercise Heart Rate (HRexercise)
Ramy czasowe: from baseline to 8 weeks
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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.
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from baseline to 8 weeks
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Rest Arterial Systolic Blood Pressure (SBPrest)
Ramy czasowe: from baseline to 8 weeks
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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.
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from baseline to 8 weeks
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Rest Arterial Diastolic Blood Pressure (DBPrest)
Ramy czasowe: Change from baseline DBPrest at 8 weeks
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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.
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Change from baseline DBPrest at 8 weeks
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Parameters of Static balance (Amplitude ans Speed of Center of pressure in X, Y and Z axis)
Ramy czasowe: Change from baseline Parameters of Static Balance at 8 weeks
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This outcome will be measure through of Static Balance in Force Platform (AMTI)
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Change from baseline Parameters of Static Balance at 8 weeks
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Parameters of Dynamic variability (coefficient of variation (CoV) of Stride length (SL), stride frequency (SF), swing time (ST), and contact time (CT)
Ramy czasowe: Change from baseline Parameters of Dynamic Balance at 8 weeks
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This outcome will be measure through of the variability on sub-maximal test of walking treadmill, using the three-dimensional motion analysis system (VICON).
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Change from baseline Parameters of Dynamic Balance at 8 weeks
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Spatial Temporal Parameters (stride frequency, stride length, swing time and contact time)
Ramy czasowe: Change from baseline Spatial Temporal parameters at 8 weeks
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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.
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Change from baseline Spatial Temporal parameters at 8 weeks
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Parameters of Pendular Mechanism (external, internal and total mechanical work, Wext, Wint and Wtot, respectively, Recovery).
Ramy czasowe: Change from baseline Parameters of Mechanical Work at 8 weeks
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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.
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Change from baseline Parameters of Mechanical Work at 8 weeks
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Other Parameters of Pendular Mechanism (Percentage of congruity (%Cong), instantaneous pendular transduction and Recovery of step, shift phase (PhaseShift).
Ramy czasowe: Change from baseline other Parameters of Pendular Mechanism at 8 weeks
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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.
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Change from baseline other Parameters of Pendular Mechanism at 8 weeks
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Movement Body Center of Mass (BCoM) on X, Y, Z axis
Ramy czasowe: Change from baseline of BCoM at 8 weeks
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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.
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Change from baseline of BCoM at 8 weeks
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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)
Ramy czasowe: Change from baseline MVC at 8 weeks
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This outcome will be measured through Measuring the electromyographic activation during treadmill walking tests using the Miotool electromyograph
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Change from baseline MVC at 8 weeks
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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)
Ramy czasowe: Change from baseline Electromyographic parameters at 8 weeks
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This outcome will be measured through Measuring the electromyographic activation during treadmill walking tests using an electromyograph
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Change from baseline Electromyographic parameters at 8 weeks
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Śledczy
- Główny śledczy: Leonardo A Peyré-Tartaruga, PhD, PhD student of the Federal University of Rio Grande do Sul- Brasil
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- 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.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 marca 2014
Zakończenie podstawowe (Rzeczywisty)
1 października 2014
Ukończenie studiów (Rzeczywisty)
1 grudnia 2016
Daty rejestracji na studia
Pierwszy przesłany
8 grudnia 2016
Pierwszy przesłany, który spełnia kryteria kontroli jakości
24 marca 2017
Pierwszy wysłany (Rzeczywisty)
31 marca 2017
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
31 marca 2017
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
24 marca 2017
Ostatnia weryfikacja
1 marca 2017
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- LTartaruga,
Plan dla danych uczestnika indywidualnego (IPD)
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