- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03262714
Effects of Dancing on Cardiovascular and Functional Risk Factors in Older Women.
2017년 8월 23일 업데이트: Alvaro Reischak-Oliveira, Federal University of Rio Grande do Sul
Effects of Dancing and Walking on Cardiovascular Risk Factors and Functional Capacity in Older Women: a Randomized Controlled Trial.
The goal of this randomized controlled trial is to investigate the effects of a dance intervention on cardiovascular risk factors and functional capacity of older women, comparing dancing to a walking exercise intervention and to an active control condition (stretching).
The participants will include women between 60 and 80 years old, with body mass index inferior to 35 Kg /m2.
The main outcome of this study is the peak oxygen consumption (VO2peak).
The secondary outcomes are cardiovascular risk associated factors (C-reactive protein, TNF-alpha, lipid profile, etc) and functional performance (muscle strength and power, balance, gate ability, etc).
The experimental design will include 3 parts: 1) Pre-intervention assessments: medical evaluation, fasting blood exams, maximum exercise test, assessments of body composition, balance, gate ability, muscular strength and power.
2) Period of interventions: patients will be randomized to one of the three following groups: dance, walking or stretching.
The duration of the interventions will be 8 weeks, including 3 sessions per week for dance and walking, and once a week for the stretching group.
Each session will last 60 min.
3) Post-intervention assessments: the same protocols of testing as pre-intervention.
연구 개요
상세 설명
The aging process is characterized by reductions of lean mass simultaneously to increases in visceral adipose tissue.
Metabolically, this is related to insulin resistance and higher risk to develop cardiovascular diseases.
Functionally, loss of strength and cardiorespiratory fitness may lead to early muscle fatigue onset, which may limit the performance of daily activities, and eventually lead to loss of independence with aging.
Dancing has been used as a form of exercise to improve functional and metabolic outcomes during aging.
However, the field lacks of randomized controlled trials (RCT) evaluating metabolic outcomes related to dance interventions, as well as comparisons of dancing with other types of exercise on functional performance and metabolic health of older adults.
Therefore, the goal of this randomized controlled trial is to investigate the effects of a dance intervention on cardiovascular risk factors and functional capacity of older women, comparing dancing to a walking exercise intervention and to an active control condition (stretching).
Additionally, we aim to investigate the acute cardiorespiratory responses of a dance session.
The participants will include women between 60 and 80 years old, with body mass index inferior to 35 Kg /m2 and independent for performing daily activities.
They should not be engaged in any type of regular physical activity in the past 6 months.
Exclusion criteria will include type 2 diabetes mellitus, cardiovascular complications and neurodegenerative diseases.
The main outcome of this study is the peak oxygen consumption (VO2peak), as it has been associated with both, cardiovascular risk and functional performance in aging individuals.
The secondary outcomes are: (1) cardiovascular risk associated factors: C-reactive protein, TNF-alpha, triglycerides, total cholesterol, LDL-cholesterol, HDL-cholesterol, fasting glucose and insulin, and homeostatic model assessment of insulin resistance (HOMA-IR).
(2) Functional performance: muscle strength and power, balance, gate ability and muscle quality.
The experimental design will include 3 parts: 1) Pre-intervention assessments: medical evaluation, fasting blood exams, maximum exercise test, assessments of body composition, balance, gate ability, muscular strength and power.
2) Period of interventions: patients will be randomized in blocks (randomization.com), in accordance to their VO2peak , to one of the three following groups: dance, walking or control.
The duration of the dance and walking interventions will be 8 weeks, including 3 sessions per week, each lasting 60 min.
Dance classes will be performed in group in a dance studio, including a variety of rhythms such as salsa, jazz and aerobics.
Walking sessions will be performed individually or in groups of two people, in a treadmill, at the gym.
The control group will have 60min stretching classes once a week, also for 8 weeks.
3) Post-intervention assessments: the same protocols of testing of the pre-interventions assessments will be repeated.
All the assessments and interventions will be held at the Laboratory of Research in Exercise (LAPEX-UFRGS).
연구 유형
중재적
등록 (예상)
30
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
- 모병
- Universidade Federal do Rio Grande do Sul
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연락하다:
- Josianne Rodrigues-Krause, MSc
- 전화번호: 55-51-999101821
- 이메일: rodrigues.krause@ufrgs.br
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연락하다:
- Alvaro Reischak-Oliveira, PhD
- 전화번호: 55-51-3308-5862
- 이메일: alvaro.oliveira@ufrgs.br
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부수사관:
- Josianne Rodrigues-Krause, MSc
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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
여성
설명
Inclusion Criteria:
- Women between 60 and 80 years old
- BMI inferior to 35 kg/m2
- Independent for performing daily activities (OARS scale)
- Not engaged in any type of regular exercise programme for the past 6 months
Exclusion Criteria:
- Type 2 diabetes mellitus, dyslipidemia, cardiovascular diseases or other non-controlled metabolic disorders
- Chronic diseases such as fibromyalgia, cancer or neurodegenerative disorders
- Bone, joints or muscle problems that could impair exercise performance
- Not being able to perform the effort test in the first assessment session, abnormal electrocardiogram, or any other condition identified by the physician of the study that limit the engagement in an exercise training programme.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Dancing
Elderly women randomized to the dance intervention programme.
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Participants randomized to the dance group will take part in a dance intervention programme for 8 weeks, including 3 sessions per week, each lasting 60 min.
Dance classes will be performed in group in a dance studio, including a variety of rhythms such as salsa, jazz and aerobics.
The dance session wil include a warm up of 15 min (posture, join mobility and dance technique), a main part of 40 min (learning of specific choreographies and practice of moves across the floor), and a cool down of 5 min (muscle stretching and relaxation).
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실험적: Walking
Elderly women randomized to the walking intervention programme.
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Participants randomized to the walking group will take part in a walking intervention programme for 8 weeks, including 3 sessions per week, each lasting 60 min.
The walking session will include a warm up of 10 min (posture and join mobility), a main part of 40 min (walking on a treadmill with a heart rate corresponding to 60% of VO2peak), and a cool down of 10 min (muscle stretching and relaxation).
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활성 비교기: Stretching
Elderly women randomized to the stretching intervention programme.
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Participants randomized to the control group will take part in stretching classes, once a week, each lasting 60 min, also for 8 weeks.
Stretching exercises for large muscle groups will be performed standing or in a match, holding the positions for a maximum of 10 s.
There will be no music playing during the session.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Peak Oxygen Consumption (VO2peak)
기간: Baseline and 8 weeks
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The maximum capacity of oxygen consumption measured during an incremental exercise test.
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Baseline and 8 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in C-reactive protein (CRP)
기간: Baseline and 8 weeks
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Cardiovascular risk marker.
It will be analyzed in plasma, using ELISA specific kits.
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Baseline and 8 weeks
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Change in Tumor necrosis factor alpha (TNF-alpha)
기간: Baseline and 8 weeks
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Inflammatory marker.
It will be analyzed in plasma, using ELISA specific kits.
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Baseline and 8 weeks
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Change in Triglycerides
기간: Baseline and 8 weeks
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Lipid profile marker.
It will be analyzed in plasma, by enzymatic colorimetric method, using an automatic analyzer (ROCHE, Cobas C111, Switzerland).
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Baseline and 8 weeks
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Change in Total Cholesterol
기간: Baseline and 8 weeks
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Lipid profile marker.
It will be analyzed in plasma, by enzymatic colorimetric method, using an automatic analyzer (ROCHE, Cobas C111, Switzerland).
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Baseline and 8 weeks
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Change in LDL-Cholesterol
기간: Baseline and 8 weeks
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Lipid profile marker.
Estimation of the LDL concentration will be calculate using the formula of Friedewald.
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Baseline and 8 weeks
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Change in HDL-Cholesterol
기간: Baseline and 8 weeks
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Lipid profile marker.
It will be analyzed in plasma, by enzymatic colorimetric method, using an automatic analyzer (ROCHE, Cobas C111, Switzerland).
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Baseline and 8 weeks
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Change in Fasting Glycemia
기간: Baseline and 8 weeks
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Glycaemic profile marker.
It will be analyzed in plasma, by enzymatic colorimetric method, using an automatic analyzer (ROCHE, Cobas C111, Switzerland).
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Baseline and 8 weeks
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Change in Fasting Insulin
기간: Baseline and 8 weeks
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Glycaemic profile marker.
It will be measured in plasma, usin a high sensitivity enzyme-linked immunosorbent assay.
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Baseline and 8 weeks
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Change in HOMA-IR
기간: Baseline and 8 weeks
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Glycaemic profile marker.
Homeostatic model of insulin resistance.
It will be calculated according to the following formula: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5.
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Baseline and 8 weeks
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Change in Muscle Strength
기간: Baseline and 8 weeks
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Isometric peak torque of the knee extensors will be measured using an isokinetic dynamometer (Cybex Norm, EUA).
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Baseline and 8 weeks
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Change in Muscle Power
기간: Baseline and 8 weeks
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Lower body muscle power will be measured by the performance of the counter movement jump in a force platform.
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Baseline and 8 weeks
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Change in Muscle Quality
기간: Baseline and 8 weeks
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Echo intensity of the quadriceps will be analyzed by ultrasound images.
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Baseline and 8 weeks
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Change in Static Balance
기간: Baseline and 8 weeks
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Static balance will be measured by a single leg support balance test, performed with both legs, with the eyes open and closed.
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Baseline and 8 weeks
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Change in Dynamic Balance
기간: Baseline and 8 weeks
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Dynamic balance will be measured by the Time to Up ang Go (TUG) test.
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Baseline and 8 weeks
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Change in Gate ability
기간: Baseline and 8 weeks
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Gate ability will be measured in a 10m track, picking up objects and passing over obstacles.
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Baseline and 8 weeks
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Change in Body Weight
기간: Baseline and 8 weeks
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Measurements of body weight will be measured in a digital scale.
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Baseline and 8 weeks
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Change in Waist Circumference
기간: Baseline and 8 weeks
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Measurements of waist circumference will be performed with a measuring tape.
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Baseline and 8 weeks
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Change in Percentage of Body Fat
기간: Baseline and 8 weeks
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Measurements of skinfolds will be taken to calculate the percentage of body fat.
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Baseline and 8 weeks
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Change in Sit and Stand ability
기간: Baseline and 8 weeks
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The ability to sit and stand in a chair 5 times, as fast as possible.
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Baseline and 8 weeks
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Changes in Fall Risk
기간: Baseline and 8 weeks
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The risk of fall will be measured by the performance in the TUG test.
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Baseline and 8 weeks
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Changes in the Fear of Falling
기간: Baseline and 8 weeks
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The fear of falling will be analyzed by the Falls Efficacy Scale-International Brazil (FES-I-Brazil).
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Baseline and 8 weeks
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Changes in Quality of Life
기간: Baseline and 8 weeks
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Quality of life will be analyzed by the questionary WHOQOL (World Health Organization Quality of Life.
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Baseline and 8 weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Alvaro Reischak-Oliveira, PhD., Federal University of Rio Grande do Sul
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
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 (실제)
2017년 8월 1일
기본 완료 (예상)
2017년 12월 1일
연구 완료 (예상)
2018년 8월 1일
연구 등록 날짜
최초 제출
2017년 8월 8일
QC 기준을 충족하는 최초 제출
2017년 8월 23일
처음 게시됨 (실제)
2017년 8월 25일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 8월 25일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 8월 23일
마지막으로 확인됨
2017년 8월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 53834516.0.0000.5347
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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. .
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