- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03096964
Nordic Walking Training for Older People (Pole walking)
2017년 3월 24일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
32
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, 브라질, 90690-200
- Federal University of Rio Grande do Sul
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
60년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Self-selected walking speed - SSWS
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Quality of life (QoL)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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).
기간: 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).
기간: 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
기간: 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)
기간: 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)
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Leonardo A Peyré-Tartaruga, PhD, PhD student of the Federal University of Rio Grande do Sul- Brasil
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2014년 3월 1일
기본 완료 (실제)
2014년 10월 1일
연구 완료 (실제)
2016년 12월 1일
연구 등록 날짜
최초 제출
2016년 12월 8일
QC 기준을 충족하는 최초 제출
2017년 3월 24일
처음 게시됨 (실제)
2017년 3월 31일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 3월 31일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 3월 24일
마지막으로 확인됨
2017년 3월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- LTartaruga,
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .