Effect of a High Intensity Interval Training in Older Adults With Coronary Artery Disease
研究概览
详细说明
A study comparing 2 groups: high intensity interval training and control group. Interval training group will perform a two-month physiotherapy program based in exercises, at a high intensity, and stretching of muscles at the end. Intensity will be established based on Borg scale and an effort test.
Control group will not perform any physiotherapy program, but will have usual care with medication.
Several parameters will be evaluated at baseline, 2 months and 6 months: anxiety, depression, functional capacity, blood pressure, lipid profile, physical activity, ecc.
研究类型
注册 (实际的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Diagnosed of coronary artery disease
- Discharged from hospital, less than 2 months
Exclusion Criteria:
- Not able to move by themselves
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Interval training
Physiotherapy program during two months: Interval training at a high intensity, inlcuding a warm-up and a cool-down.
Aerobic exercises, resistance exercises, stretching
|
|
无干预:Control group
No physiotherapy
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
腹围
大体时间:2个月
|
腹围厘米
|
2个月
|
腹围
大体时间:6个月
|
腹围厘米
|
6个月
|
Kinesiophobia
大体时间:baseline
|
Tampa Scale for Kinesiophobia (TSK-11SV) (Spanish adaptation.
Gómez-Pérez, López-Martínez y Ruiz-Párraga, 2011).
Scoring: Items are summed, with a total score from 11-44 and higher values represent a worse outcome (more pain interference in behavior).
|
baseline
|
Kinesiophobia
大体时间:2 months
|
Tampa Scale for Kinesiophobia (TSK-11SV) (Spanish adaptation.
Gómez-Pérez, López-Martínez y Ruiz-Párraga, 2011).
Scoring: Items are summed, with a total score from 11-44 and higher values represent a worse outcome (more pain interference in behavior).
|
2 months
|
Kinesiophobia
大体时间:6 months
|
Tampa Scale for Kinesiophobia (TSK-11SV) (Spanish adaptation.
Gómez-Pérez, López-Martínez y Ruiz-Párraga, 2011).
Scoring: Items are summed, with a total score from 11-44 and higher values represent a worse outcome (more pain interference in behavior).
|
6 months
|
body mass index
大体时间:baseline
|
body mass index, m/kg2
|
baseline
|
body mass index
大体时间:2 months
|
body mass index, m/kg2
|
2 months
|
body mass index
大体时间:6 months
|
body mass index, m/kg2
|
6 months
|
abdominal circumference
大体时间:baseline
|
abdominal circumference in cm
|
baseline
|
body fat
大体时间:baseline
|
Bioimpedanciometer OMRON HBF-500INT body fat in %
|
baseline
|
body fat
大体时间:2 months
|
Bioimpedanciometer OMRON HBF-500INT body fat in %
|
2 months
|
body fat
大体时间:6 months
|
Bioimpedanciometer OMRON HBF-500INT body fat in %
|
6 months
|
visceral fat
大体时间:baseline
|
Bioimpedanciometer OMRON HBF-500INT visceral fat in %
|
baseline
|
visceral fat
大体时间:2 months
|
Bioimpedanciometer OMRON HBF-500INT visceral fat in %
|
2 months
|
visceral fat
大体时间:6 months
|
Bioimpedanciometer OMRON HBF-500INT visceral fat in %
|
6 months
|
muscle mass
大体时间:baseline
|
Bioimpedanciometer OMRON HBF-500INT muscle mass in %
|
baseline
|
muscle mass
大体时间:2 months
|
Bioimpedanciometer OMRON HBF-500INT muscle mass in %
|
2 months
|
muscle mass
大体时间:6 months
|
Bioimpedanciometer OMRON HBF-500INT muscle mass in %
|
6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
anxiety
大体时间:baseline
|
Hospital anxiety and depression questionnaire: the questionnaire includes 14 questions regarding the depressant and anxious symptoms of the patient.
Two subsets of 7 items each, on Likert scale 0-3.
For anxiety HAD-A sum of odd items (1,3,5,7,9,11,13), for depression HAD-D sum of even items (2,4,6,8,10,12,14 ), with a score range in each subscale of 0-21.
A higher score means greater anxiety and depression.
For both subscales, scores higher than eleven would indicate "case" and greater than eight would be considered "probable case".
The internal consistency for the Spanish population is HAD-A α = .83
and HAD-D α = .87
(Vallejo, Rivera, Esteve-Vives and RodríguezMuñoz, 2012).
|
baseline
|
anxiety
大体时间:2 months
|
Hospital anxiety and depression questionnaire: the questionnaire includes 14 questions regarding the depressant and anxious symptoms of the patient.
Two subsets of 7 items each, on Likert scale 0-3.
For anxiety HAD-A sum of odd items (1,3,5,7,9,11,13), for depression HAD-D sum of even items (2,4,6,8,10,12,14 ), with a score range in each subscale of 0-21.
A higher score means greater anxiety and depression.
For both subscales, scores higher than eleven would indicate "case" and greater than eight would be considered "probable case".
The internal consistency for the Spanish population is HAD-A α = .83
and HAD-D α = .87
(Vallejo, Rivera, Esteve-Vives and RodríguezMuñoz, 2012).
|
2 months
|
anxiety
大体时间:6 months
|
Hospital anxiety and depression questionnaire: the questionnaire includes 14 questions regarding the depressant and anxious symptoms of the patient.
Two subsets of 7 items each, on Likert scale 0-3.
For anxiety HAD-A sum of odd items (1,3,5,7,9,11,13), for depression HAD-D sum of even items (2,4,6,8,10,12,14 ), with a score range in each subscale of 0-21.
A higher score means greater anxiety and depression.
For both subscales, scores higher than eleven would indicate "case" and greater than eight would be considered "probable case".
The internal consistency for the Spanish population is HAD-A α = .83
and HAD-D α = .87
(Vallejo, Rivera, Esteve-Vives and RodríguezMuñoz, 2012).
|
6 months
|
depression
大体时间:baseline
|
Hospital anxiety and depression questionnaire: the questionnaire includes 14 questions regarding the depressant and anxious symptoms of the patient.
Two subsets of 7 items each, on Likert scale 0-3.
For anxiety HAD-A sum of odd items (1,3,5,7,9,11,13), for depression HAD-D sum of even items (2,4,6,8,10,12,14 ), with a score range in each subscale of 0-21.
A higher score means greater anxiety and depression.
For both subscales, scores higher than eleven would indicate "case" and greater than eight would be considered "probable case".
The internal consistency for the Spanish population is HAD-A α = .83
and HAD-D α = .87
(Vallejo, Rivera, Esteve-Vives and RodríguezMuñoz, 2012).
|
baseline
|
depression
大体时间:2 months
|
Hospital anxiety and depression questionnaire: the questionnaire includes 14 questions regarding the depressant and anxious symptoms of the patient.
Two subsets of 7 items each, on Likert scale 0-3.
For anxiety HAD-A sum of odd items (1,3,5,7,9,11,13), for depression HAD-D sum of even items (2,4,6,8,10,12,14 ), with a score range in each subscale of 0-21.
A higher score means greater anxiety and depression.
For both subscales, scores higher than eleven would indicate "case" and greater than eight would be considered "probable case".
The internal consistency for the Spanish population is HAD-A α = .83
and HAD-D α = .87
(Vallejo, Rivera, Esteve-Vives and RodríguezMuñoz, 2012).
|
2 months
|
depression
大体时间:6 months
|
Hospital anxiety and depression questionnaire: the questionnaire includes 14 questions regarding the depressant and anxious symptoms of the patient.
Two subsets of 7 items each, on Likert scale 0-3.
For anxiety HAD-A sum of odd items (1,3,5,7,9,11,13), for depression HAD-D sum of even items (2,4,6,8,10,12,14 ), with a score range in each subscale of 0-21.
A higher score means greater anxiety and depression.
For both subscales, scores higher than eleven would indicate "case" and greater than eight would be considered "probable case".
The internal consistency for the Spanish population is HAD-A α = .83
and HAD-D α = .87
(Vallejo, Rivera, Esteve-Vives and RodríguezMuñoz, 2012).
|
6 months
|
physical activity
大体时间:baseline
|
International physical activity questionnaire: it has 9 items and provides information on the time spent while walking, in activities of low, moderate and vigorous intensity and in sedentary activities.
Based on the estimated METS consumed, the IPAQ divides the subjects into three levels or categories: Low, moderate and high physical activity.
The score of the different types of activity is expressed in METS-minutes per week.
|
baseline
|
physical activity
大体时间:2 months
|
International physical activity questionnaire: it has 9 items and provides information on the time spent while walking, in activities of low, moderate and vigorous intensity and in sedentary activities.
Based on the estimated METS consumed, the IPAQ divides the subjects into three levels or categories: Low, moderate and high physical activity.
The score of the different types of activity is expressed in METS-minutes per week.
|
2 months
|
physical activity
大体时间:6 months
|
International physical activity questionnaire: it has 9 items and provides information on the time spent while walking, in activities of low, moderate and vigorous intensity and in sedentary activities.
Based on the estimated METS consumed, the IPAQ divides the subjects into three levels or categories: Low, moderate and high physical activity.
The score of the different types of activity is expressed in METS-minutes per week.
|
6 months
|
functional capacity
大体时间:baseline
|
Incremental shuttle walk test will be used to measure functional capacity. Patients were required to walk along a level 10 m course at a previously determined speed dictated by signals from an audio tape recorder. The walking speed was progressively increased at 1 min intervals, for a total of 12 stages. The test was terminated if the patient was unable to continue at the desired speed or if the patient failed to complete the shuttle course in the allowed time. Distance walked were determined on exercise cessation (meters). |
baseline
|
functional capacity
大体时间:2 months
|
Incremental shuttle walk test will be used to measure functional capacity. Patients were required to walk along a level 10 m course at a previously determined speed dictated by signals from an audio tape recorder. The walking speed was progressively increased at 1 min intervals, for a total of 12 stages. The test was terminated if the patient was unable to continue at the desired speed or if the patient failed to complete the shuttle course in the allowed time. Distance walked were determined on exercise cessation (meters). |
2 months
|
functional capacity
大体时间:6 months
|
Incremental shuttle walk test will be used to measure functional capacity. Patients were required to walk along a level 10 m course at a previously determined speed dictated by signals from an audio tape recorder. The walking speed was progressively increased at 1 min intervals, for a total of 12 stages. The test was terminated if the patient was unable to continue at the desired speed or if the patient failed to complete the shuttle course in the allowed time. Distance walked were determined on exercise cessation (meters). |
6 months
|
brachial systolic and diastolic blood pressure
大体时间:baseline
|
systolic and diastolic blood pressure (mmHg)
|
baseline
|
brachial systolic and diastolic blood pressure
大体时间:2 months
|
systolic and diastolic blood pressure (mmHg)
|
2 months
|
brachial systolic and diastolic blood pressure
大体时间:6 months
|
systolic and diastolic blood pressure (mmHg)
|
6 months
|
health related quality of life
大体时间:baseline
|
Short-form 36: the questionnaire is composed of 36 questions that value both positive and negative health status.
It was developed from an extensive battery of questionnaires employed at WHO, which included 40 concepts related to health.
The questionnaire contains 8 scales, which represent the concepts of health most frequently used in the main health questionnaires.
The 36 items of the instrument cover the following scales: Physical function, Physical role, Body pain, General health, Vitality, Social function, Emotional role, Mental health.
The scores of each of the 8 dimensions of the SF-36 oscillate between 0 and 100.
A result of 100 indicates optimal health and 0 would reflect a very poor state of health.
|
baseline
|
health related quality of life
大体时间:2 months
|
Short-form 36: the questionnaire is composed of 36 questions that value both positive and negative health status.
It was developed from an extensive battery of questionnaires employed at WHO, which included 40 concepts related to health.
The questionnaire contains 8 scales, which represent the concepts of health most frequently used in the main health questionnaires.
The 36 items of the instrument cover the following scales: Physical function, Physical role, Body pain, General health, Vitality, Social function, Emotional role, Mental health.
The scores of each of the 8 dimensions of the SF-36 oscillate between 0 and 100.
A result of 100 indicates optimal health and 0 would reflect a very poor state of health.
|
2 months
|
health related quality of life
大体时间:6 months
|
Short-form 36: the questionnaire is composed of 36 questions that value both positive and negative health status.
It was developed from an extensive battery of questionnaires employed at WHO, which included 40 concepts related to health.
The questionnaire contains 8 scales, which represent the concepts of health most frequently used in the main health questionnaires.
The 36 items of the instrument cover the following scales: Physical function, Physical role, Body pain, General health, Vitality, Social function, Emotional role, Mental health.
The scores of each of the 8 dimensions of the SF-36 oscillate between 0 and 100.
A result of 100 indicates optimal health and 0 would reflect a very poor state of health.
|
6 months
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Interval training的临床试验
-
Karolinska InstitutetMinistry of Health and Social Affairs, Sweden完全的
-
Mental Health Services in the Capital Region, DenmarkCopenhagen Trial Unit, Center for Clinical Intervention Research; Center for Clinical Intervention...完全的