- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT03096964
Nordic Walking Training for Older People (Pole walking)
24 марта 2017 г. обновлено: 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.
Обзор исследования
Статус
Завершенный
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Действительный)
32
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Бразилия, 90690-200
- Federal University of Rio Grande do Sul
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
От 60 лет до 80 лет (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Да
Полы, имеющие право на обучение
Все
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 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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Экспериментальный: 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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Self-selected walking speed - SSWS
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Quality of life (QoL)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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).
Временное ограничение: 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).
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Следователи
- Главный следователь: Leonardo A Peyré-Tartaruga, PhD, PhD student of the Federal University of Rio Grande do Sul- Brasil
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- 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.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования
1 марта 2014 г.
Первичное завершение (Действительный)
1 октября 2014 г.
Завершение исследования (Действительный)
1 декабря 2016 г.
Даты регистрации исследования
Первый отправленный
8 декабря 2016 г.
Впервые представлено, что соответствует критериям контроля качества
24 марта 2017 г.
Первый опубликованный (Действительный)
31 марта 2017 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
31 марта 2017 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
24 марта 2017 г.
Последняя проверка
1 марта 2017 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- LTartaruga,
Планирование данных отдельных участников (IPD)
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НЕТ
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .