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

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Other: Exercise

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Select A State…
    • Gothenburg, Select A State…, Sweden, 41345
      • Department of physiotherapy, Sahlgrenska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 80 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise; 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	Other: Exercise; 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
No Intervention: Control; Patients are asked to live as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in maximum aerobic capacity	A maximum exercise test on an electronically braked cycle ergometer, with watts as marker of maximum aerobic capacity.	At baseline and after 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in level of physical activity	Level of physical activity will be measured by an accelerometer and an activity diary	At baseline and after 4 months
Change in muscular endurance	Will be measured by three clinical endurance tests including unilateral isotonic heel lift, unilateral isotonic shoulder flexion, bilateral isometric shoulder abduction	At baseline and after 4 months
Change in physical functioning	Including tests of balance: short physical performance battery, one leg standing, timed up and go, and the activities specific balance confidence scale.	At baseline and after 4 months
Change in health related quality of life	measured by a self-rated health questionnaire	At baselline and after 4 months
Change in anxiety and depression	measured by the hospital anxiety and depression scale	At baseline and after 4 months
Change in endothelial function	Evaluated with non-invasive ultrasound	At baseline and after 4 months
Change in transthoracic evaluation of resting coronary flow velocity		At baseline and after 4 months

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital, Sweden
• Investigators: Principal Investigator: Maria Bäck, PhD, Department of Physiotherapy, Sahlgrenska University Hospital, Gothenburg, Sweden; Study Chair: Per Albertsson, PhD, Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden

Publications and helpful links

General Publications

• Brosved M, Hirlekar G, Philip Wigh J, Sundberg H, Ziden L, Karlsson T, Albertsson P, Back M. Effects of Cardiac Rehabilitation on Physical Fitness, Physical Function, and Self-reported Outcomes in Patients >/=80 yr: A RANDOMIZED CONTROLLED TRIAL. J Cardiopulm Rehabil Prev. 2022 Sep 1;42(5):331-337. doi: 10.1097/HCR.0000000000000683. Epub 2022 Mar 31.

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): April 1, 2022

Study Registration Dates

• First Submitted: October 21, 2013
• First Submitted That Met QC Criteria: December 27, 2013
• First Posted (Estimate): January 1, 2014

Study Record Updates

• Last Update Posted (Actual): April 15, 2022
• Last Update Submitted That Met QC Criteria: April 10, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: exercise; elderly; coronary artery disease; exercise-based cardiac rehabilitation
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 462-13