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

Not Applicable
Completed
Conditions
Heart Diseases
Interventions
Other: Interval training
Registration Number
NCT04425057
Lead Sponsor
University of Valencia
Brief 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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
90
Inclusion Criteria
  • Diagnosed of coronary artery disease
  • Discharged from hospital, less than 2 months
Exclusion Criteria
  • Not able to move by themselves

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Interval trainingInterval trainingPhysiotherapy program during two months: Interval training at a high intensity, inlcuding a warm-up and a cool-down. Aerobic exercises, resistance exercises, stretching
Primary Outcome Measures
NameTimeMethod
body fat6 months

Bioimpedanciometer OMRON HBF-500INT body fat in %

muscle mass6 months

Bioimpedanciometer OMRON HBF-500INT muscle mass in %

Kinesiophobia6 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).

abdominal circumference6 months

abdominal circumference in cm

visceral fat6 months

Bioimpedanciometer OMRON HBF-500INT visceral fat in %

body mass index6 months

body mass index, m/kg2

Secondary Outcome Measures
NameTimeMethod
brachial systolic and diastolic blood pressure6 months

systolic and diastolic blood pressure (mmHg)

health related quality of life6 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.

anxiety6 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).

depression6 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).

functional capacity6 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).

physical activity6 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.

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