Effect of a High Intensity Interval Training in Older Adults With Coronary Artery Disease
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Diagnosed of coronary artery disease
- Discharged from hospital, less than 2 months
Exclusion Criteria:
- Not able to move by themselves
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的: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
|
|
介入なし:Control group
No physiotherapy
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
腹囲
時間枠:2ヶ月
|
腹囲(cm)
|
2ヶ月
|
腹囲
時間枠:6ヵ月
|
腹囲(cm)
|
6ヵ月
|
Kinesiophobia
時間枠: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
時間枠: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
時間枠: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
時間枠:baseline
|
body mass index, m/kg2
|
baseline
|
body mass index
時間枠:2 months
|
body mass index, m/kg2
|
2 months
|
body mass index
時間枠:6 months
|
body mass index, m/kg2
|
6 months
|
abdominal circumference
時間枠:baseline
|
abdominal circumference in cm
|
baseline
|
body fat
時間枠:baseline
|
Bioimpedanciometer OMRON HBF-500INT body fat in %
|
baseline
|
body fat
時間枠:2 months
|
Bioimpedanciometer OMRON HBF-500INT body fat in %
|
2 months
|
body fat
時間枠:6 months
|
Bioimpedanciometer OMRON HBF-500INT body fat in %
|
6 months
|
visceral fat
時間枠:baseline
|
Bioimpedanciometer OMRON HBF-500INT visceral fat in %
|
baseline
|
visceral fat
時間枠:2 months
|
Bioimpedanciometer OMRON HBF-500INT visceral fat in %
|
2 months
|
visceral fat
時間枠:6 months
|
Bioimpedanciometer OMRON HBF-500INT visceral fat in %
|
6 months
|
muscle mass
時間枠:baseline
|
Bioimpedanciometer OMRON HBF-500INT muscle mass in %
|
baseline
|
muscle mass
時間枠:2 months
|
Bioimpedanciometer OMRON HBF-500INT muscle mass in %
|
2 months
|
muscle mass
時間枠:6 months
|
Bioimpedanciometer OMRON HBF-500INT muscle mass in %
|
6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
anxiety
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠:baseline
|
systolic and diastolic blood pressure (mmHg)
|
baseline
|
brachial systolic and diastolic blood pressure
時間枠:2 months
|
systolic and diastolic blood pressure (mmHg)
|
2 months
|
brachial systolic and diastolic blood pressure
時間枠:6 months
|
systolic and diastolic blood pressure (mmHg)
|
6 months
|
health related quality of life
時間枠: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
時間枠: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
時間枠: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
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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