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Effect of a High Intensity Interval Training in Older Adults With Coronary Artery Disease

2021年1月25日 更新者:Elena Marques-Sule、University of Valencia
A study comparing 2 groups: interval training and control group. Interval training group will perform a physiotherapy program based in exercises, at a high intensity, and stretching of muscles at the end. Control group will not perform any physiotherapy program. Several parameters will be evaluated at baseline, 2 months and 6 months: anxiety, depression, functional capacity, blood pressure, lipid profile, physical activity, ecc.

調査の概要

状態

完了

条件

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

介入

入学 (実際)

90

段階

  • 適用できない

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

65年歳以上 (高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

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

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2012年10月1日

一次修了 (実際)

2013年1月1日

研究の完了 (実際)

2013年9月1日

試験登録日

最初に提出

2018年12月31日

QC基準を満たした最初の提出物

2020年6月6日

最初の投稿 (実際)

2020年6月11日

学習記録の更新

投稿された最後の更新 (実際)

2021年1月28日

QC基準を満たした最後の更新が送信されました

2021年1月25日

最終確認日

2021年1月1日

詳しくは

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個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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心臓疾患の臨床試験

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