- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03096964
Nordic Walking Training for Older People (Pole walking)
24. marts 2017 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
32
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brasilien, 90690-200
- Federal University of Rio Grande do Sul
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
60 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
|
Eksperimentel: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Self-selected walking speed - SSWS
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Quality of life (QoL)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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).
Tidsramme: 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).
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Leonardo A Peyré-Tartaruga, PhD, PhD student of the Federal University of Rio Grande do Sul- Brasil
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. marts 2014
Primær færdiggørelse (Faktiske)
1. oktober 2014
Studieafslutning (Faktiske)
1. december 2016
Datoer for studieregistrering
Først indsendt
8. december 2016
Først indsendt, der opfyldte QC-kriterier
24. marts 2017
Først opslået (Faktiske)
31. marts 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
31. marts 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. marts 2017
Sidst verificeret
1. marts 2017
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- LTartaruga,
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Nordic walking training
-
Je Bouge Pour Mon MoralUniversity Grenoble AlpsAfsluttetDepressive symptomerFrankrig
-
Ottawa Heart Institute Research CorporationAfsluttet
-
University of SaskatchewanSaskatchewan Health Research Foundation; Royal University Hospital Foundation og andre samarbejdspartnereAfsluttetOsteoporose | Vertebral fraktur | HyperkyfoseCanada
-
Federal University of Rio Grande do SulHospital de Clinicas de Porto Alegre; Federal University of Health Science...AfsluttetParkinsons sygdom | Parkinsons sygdom 10Brasilien
-
Arno Schmidt-TrucksässAfsluttetFedme | OvervægtigSchweiz
-
Raquel SebioFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauAfsluttet
-
Azienda Ospedaliera Universitaria Integrata VeronaUniversita di VeronaUkendtForhøjet blodtryk | Metabolisk syndrom | Overvægt og fedme | Kardiovaskulær risikofaktor | Sarkopenisk fedme | Handicap Fysisk | Abdominal fedmeItalien
-
Leonardo A. Peyré-TartarugaAline Nogueira Haas; Flávia Gomes MartinezIkke rekrutterer endnuMultipel sclerose | Multipel sklerose, kronisk progressiv | Multipel sklerose, sekundær progressiv | Multipel sklerose, primær progressivBrasilien
-
Hospital of South West JutlandUniversity of Southern DenmarkAfsluttetType 2 diabetes | Dyrke motionDanmark