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

Heart Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04425057
• Other study ID #: 2012/0113
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Est. completion date: September 2013

Study information

• Verified date: January 2021
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed of coronary artery disease

• Discharged from hospital, less than 2 months

Exclusion Criteria:

• Not able to move by themselves

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Other:
• Interval training

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kinesiophobia	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
Primary	Kinesiophobia	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
Primary	Kinesiophobia	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
Primary	body mass index	body mass index, m/kg2	baseline
Primary	body mass index	body mass index, m/kg2	2 months
Primary	body mass index	body mass index, m/kg2	6 months
Primary	abdominal circumference	abdominal circumference in cm	baseline
Primary	abdominal circumference	abdominal circumference in cm	2 months
Primary	abdominal circumference	abdominal circumference in cm	6 months
Primary	body fat	Bioimpedanciometer OMRON HBF-500INT body fat in %	baseline
Primary	body fat	Bioimpedanciometer OMRON HBF-500INT body fat in %	2 months
Primary	body fat	Bioimpedanciometer OMRON HBF-500INT body fat in %	6 months
Primary	visceral fat	Bioimpedanciometer OMRON HBF-500INT visceral fat in %	baseline
Primary	visceral fat	Bioimpedanciometer OMRON HBF-500INT visceral fat in %	2 months
Primary	visceral fat	Bioimpedanciometer OMRON HBF-500INT visceral fat in %	6 months
Primary	muscle mass	Bioimpedanciometer OMRON HBF-500INT muscle mass in %	baseline
Primary	muscle mass	Bioimpedanciometer OMRON HBF-500INT muscle mass in %	2 months
Primary	muscle mass	Bioimpedanciometer OMRON HBF-500INT muscle mass in %	6 months
Secondary	anxiety	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 a = .83 and HAD-D a = .87 (Vallejo, Rivera, Esteve-Vives and RodríguezMuñoz, 2012).	baseline
Secondary	anxiety	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 a = .83 and HAD-D a = .87 (Vallejo, Rivera, Esteve-Vives and RodríguezMuñoz, 2012).	2 months
Secondary	anxiety	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 a = .83 and HAD-D a = .87 (Vallejo, Rivera, Esteve-Vives and RodríguezMuñoz, 2012).	6 months
Secondary	depression	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 a = .83 and HAD-D a = .87 (Vallejo, Rivera, Esteve-Vives and RodríguezMuñoz, 2012).	baseline
Secondary	depression	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 a = .83 and HAD-D a = .87 (Vallejo, Rivera, Esteve-Vives and RodríguezMuñoz, 2012).	2 months
Secondary	depression	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 a = .83 and HAD-D a = .87 (Vallejo, Rivera, Esteve-Vives and RodríguezMuñoz, 2012).	6 months
Secondary	physical activity	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
Secondary	physical activity	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
Secondary	physical activity	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
Secondary	functional capacity	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
Secondary	functional capacity	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
Secondary	functional capacity	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
Secondary	brachial systolic and diastolic blood pressure	systolic and diastolic blood pressure (mmHg)	baseline
Secondary	brachial systolic and diastolic blood pressure	systolic and diastolic blood pressure (mmHg)	2 months
Secondary	brachial systolic and diastolic blood pressure	systolic and diastolic blood pressure (mmHg)	6 months
Secondary	health related quality of life	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
Secondary	health related quality of life	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
Secondary	health related quality of life	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