- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03096964
Nordic Walking Training for Older People (Pole walking)
24 mars 2017 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
32
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brésil, 90690-200
- Federal University of Rio Grande do Sul
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
60 ans à 80 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La 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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 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.
|
Expérimental: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Self-selected walking speed - SSWS
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Quality of life (QoL)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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).
Délai: 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).
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Leonardo A Peyré-Tartaruga, PhD, PhD student of the Federal University of Rio Grande do Sul- Brasil
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 mars 2014
Achèvement primaire (Réel)
1 octobre 2014
Achèvement de l'étude (Réel)
1 décembre 2016
Dates d'inscription aux études
Première soumission
8 décembre 2016
Première soumission répondant aux critères de contrôle qualité
24 mars 2017
Première publication (Réel)
31 mars 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
31 mars 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
24 mars 2017
Dernière vérification
1 mars 2017
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- LTartaruga,
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Nordic walking training
-
Fundación Pública Andaluza para la Investigación...Complété
-
Rigshospitalet, DenmarkNovo Nordisk A/S; Copenhagen University Hospital at Herlev; Danish Cancer Society et autres collaborateursComplété
-
Università degli Studi di SassariComplétéSclérose en plaques | Fatigue | FaiblesseItalie
-
Universidad Complutense de MadridComplété
-
Queen's UniversityComplétéLes troubles mentauxCanada
-
University of OuluComplétéVentilationFinlande
-
Brno University HospitalRecrutement
-
Johns Hopkins UniversityComplétéTrouble de stress post-traumatique | Exercice d'aérobie | Taï chiÉtats-Unis
-
University of ValenciaComplétéBlessures sportivesEspagne
-
Eduardo Fonseca PedreroPsicofundación: Fundación Española para Promoción, Desarrollo Científico... et autres collaborateursRecrutementDépression | Trouble émotionnel | Trouble anxieux | Problème émotionnelEspagne