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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02025257
• Other study ID #: 462-13
• Status: Completed
• Phase: N/A
• Start date: December 2013
• Est. completion date: April 2022

Study information

• Verified date: April 2022
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: April 2022
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 80 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Sweden	Department of physiotherapy, Sahlgrenska University Hospital	Gothenburg	Select A State…

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Brosved M, Hirlekar G, Philip Wigh J, Sundberg H, Zidén L, Karlsson T, Albertsson P, Bäck M. Effects of Cardiac Rehabilitation on Physical Fitness, Physical Function, and Self-reported Outcomes in Patients =80 yr: A RANDOMIZED CONTROLLED TRIAL. J Cardiopu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Change in health related quality of life	measured by a self-rated health questionnaire	At baselline and after 4 months
Secondary	Change in anxiety and depression	measured by the hospital anxiety and depression scale	At baseline and after 4 months
Secondary	Change in endothelial function	Evaluated with non-invasive ultrasound	At baseline and after 4 months
Secondary	Change in transthoracic evaluation of resting coronary flow velocity		At baseline and after 4 months