- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04425057
Effect of a High Intensity Interval Training in Older Adults With Coronary Artery Disease
Study Overview
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosed of coronary artery disease
- Discharged from hospital, less than 2 months
Exclusion Criteria:
- Not able to move by themselves
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
|
No Intervention: Control group
No physiotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
abdominal circumference
Time Frame: 2 months
|
abdominal circumference in cm
|
2 months
|
abdominal circumference
Time Frame: 6 months
|
abdominal circumference in cm
|
6 months
|
Kinesiophobia
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: baseline
|
body mass index, m/kg2
|
baseline
|
body mass index
Time Frame: 2 months
|
body mass index, m/kg2
|
2 months
|
body mass index
Time Frame: 6 months
|
body mass index, m/kg2
|
6 months
|
abdominal circumference
Time Frame: baseline
|
abdominal circumference in cm
|
baseline
|
body fat
Time Frame: baseline
|
Bioimpedanciometer OMRON HBF-500INT body fat in %
|
baseline
|
body fat
Time Frame: 2 months
|
Bioimpedanciometer OMRON HBF-500INT body fat in %
|
2 months
|
body fat
Time Frame: 6 months
|
Bioimpedanciometer OMRON HBF-500INT body fat in %
|
6 months
|
visceral fat
Time Frame: baseline
|
Bioimpedanciometer OMRON HBF-500INT visceral fat in %
|
baseline
|
visceral fat
Time Frame: 2 months
|
Bioimpedanciometer OMRON HBF-500INT visceral fat in %
|
2 months
|
visceral fat
Time Frame: 6 months
|
Bioimpedanciometer OMRON HBF-500INT visceral fat in %
|
6 months
|
muscle mass
Time Frame: baseline
|
Bioimpedanciometer OMRON HBF-500INT muscle mass in %
|
baseline
|
muscle mass
Time Frame: 2 months
|
Bioimpedanciometer OMRON HBF-500INT muscle mass in %
|
2 months
|
muscle mass
Time Frame: 6 months
|
Bioimpedanciometer OMRON HBF-500INT muscle mass in %
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
anxiety
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: baseline
|
systolic and diastolic blood pressure (mmHg)
|
baseline
|
brachial systolic and diastolic blood pressure
Time Frame: 2 months
|
systolic and diastolic blood pressure (mmHg)
|
2 months
|
brachial systolic and diastolic blood pressure
Time Frame: 6 months
|
systolic and diastolic blood pressure (mmHg)
|
6 months
|
health related quality of life
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012/0113
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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