- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT03096964
Nordic Walking Training for Older People (Pole walking)
24. března 2017 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Detailní popis
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 studie
Intervenční
Zápis (Aktuální)
32
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brazílie, 90690-200
- Federal University of Rio Grande do Sul
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
60 let až 80 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
|
|
Experimentální: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Self-selected walking speed - SSWS
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Quality of life (QoL)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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).
Časové okno: 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).
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Vrchní vyšetřovatel: Leonardo A Peyré-Tartaruga, PhD, PhD student of the Federal University of Rio Grande do Sul- Brasil
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. března 2014
Primární dokončení (Aktuální)
1. října 2014
Dokončení studie (Aktuální)
1. prosince 2016
Termíny zápisu do studia
První předloženo
8. prosince 2016
První předloženo, které splnilo kritéria kontroly kvality
24. března 2017
První zveřejněno (Aktuální)
31. března 2017
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
31. března 2017
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
24. března 2017
Naposledy ověřeno
1. března 2017
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- LTartaruga,
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Nordic walking training
-
Chang Gung UniversityNational Science and Technology CouncilNábor
-
State University of New York at BuffaloDokončeno
-
Fondazione IRCCS Istituto Nazionale dei Tumori,...Dokončeno
-
Trinitas Comprehensive Cancer CenterAptium Oncology Research NetworkNeznámýRakovina prsuSpojené státy
-
Je Bouge Pour Mon MoralUniversity Grenoble AlpsDokončenoPříznaky depreseFrancie
-
Ottawa Heart Institute Research CorporationDokončeno
-
Human Locomotion ScienceUniversity of Southern Denmark; National Board of Health, Denmark; Nordic Institute... a další spolupracovníciNeznámý
-
University Hospital, BonnDokončenoPAOD (obstrukční onemocnění periferních tepen)Německo
-
Tel-Aviv Sourasky Medical CenterNábor
-
University of SaskatchewanSaskatchewan Health Research Foundation; Royal University Hospital Foundation; Saskatchewan Centre for Patient-Oriented ResearchDokončenoOsteoporóza | Zlomenina obratle | HyperkyfózaKanada