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Completed

NCT Number: NCT02025257

Effects of Exercise in Patients With Coronary Artery Disease Aged 80 Years or Older

The purpose of this study is to investigate the effects of exercise for patients with coronary artery disease (CAD) aged 80 years and older, with special reference to maximum aerobic capacity, muscle endurance, physical functioning, level of physical activity, health related quality of life, anxiety, depression and endothelial function, compared to a control group.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Behavior Cardiovascular Diseases Coronary Disease Heart Diseases Motor Activity Myocardial Ischemia Vascular Diseases

Age range

80 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of physiotherapy, Sahlgrenska University Hospital

Gothenburg, Select A State…, 41345, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of acute coronary artery disease
  • Aged 80 years or older

Exclusion criteria

  • Inability to understand or speak the Swedish language
  • Serious physical or psychological disease interfering with participation in an exercise intervention
  • Patients are already exercising three times or more/week

Treatment and study plan

Exercise

Other

Individually prescribed hospital based exercise in group two times a week, home-based exercise once a week. The exercise intervention consists of interval based aerobic exercise on a bicycle ergometer 30 minutes with intensity level at 13-17 at Borg scale, resistance exercises and balance exercises

Primary outcomes

  1. Change in maximum aerobic capacity

    Time frame: At baseline and after 4 months

    A maximum exercise test on an electronically braked cycle ergometer, with watts as marker of maximum aerobic capacity.

Secondary outcomes

  1. Change in level of physical activity

    Time frame: At baseline and after 4 months

    Level of physical activity will be measured by an accelerometer and an activity diary

  2. Change in muscular endurance

    Time frame: At baseline and after 4 months

    Will be measured by three clinical endurance tests including unilateral isotonic heel lift, unilateral isotonic shoulder flexion, bilateral isometric shoulder abduction

  3. Change in physical functioning

    Time frame: At baseline and after 4 months

    Including tests of balance: short physical performance battery, one leg standing, timed up and go, and the activities specific balance confidence scale.

  4. Change in health related quality of life

    Time frame: At baselline and after 4 months

    measured by a self-rated health questionnaire

  5. Change in anxiety and depression

    Time frame: At baseline and after 4 months

    measured by the hospital anxiety and depression scale

  6. Change in endothelial function

    Time frame: At baseline and after 4 months

    Evaluated with non-invasive ultrasound

  7. Change in transthoracic evaluation of resting coronary flow velocity

    Time frame: At baseline and after 4 months

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Official study title

Effects of Exercise in Patients With Coronary Artery Disease Aged 80 Years or Older - a Randomized Controlled Trial

Important dates

Study start
2013
Primary completion
2019
Study completion
2022
First posted
Jan 1, 2014
Registry last updated
Apr 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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