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

Primary Purpose

Coronary Artery Disease

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Exercise

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring coronary artery disease, elderly, exercise, exercise-based cardiac rehabilitation

Eligibility Criteria

80 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of physiotherapy, Sahlgrenska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise

Control

Arm Description

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

Patients are asked to live as usual.

Outcomes

Primary Outcome Measures

Change in maximum aerobic capacity

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

Secondary Outcome Measures

Change in level of physical activity

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

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

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.

Change in health related quality of life

measured by a self-rated health questionnaire

Change in anxiety and depression

measured by the hospital anxiety and depression scale

Change in endothelial function

Evaluated with non-invasive ultrasound

Change in transthoracic evaluation of resting coronary flow velocity

Full Information

NCT ID

NCT02025257

First Posted

October 21, 2013

Last Updated

April 10, 2022

Sponsor

Sahlgrenska University Hospital, Sweden

1. Study Identification

Unique Protocol Identification Number

NCT02025257

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

December 2013 (undefined)

Primary Completion Date

May 2019 (Actual)

Study Completion Date

April 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sahlgrenska University Hospital, Sweden

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

coronary artery disease, elderly, exercise, exercise-based cardiac rehabilitation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Exercise

Arm Type

Experimental

Arm Description

Arm Title

Control

Arm Type

No Intervention

Arm Description

Patients are asked to live as usual.

Intervention Type

Other

Intervention Name(s)

Exercise

Intervention Description

Primary Outcome Measure Information:

Title

Change in maximum aerobic capacity

Description

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

Time Frame

At baseline and after 4 months

Secondary Outcome Measure Information:

Title

Change in level of physical activity

Description

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

Time Frame

At baseline and after 4 months

Title

Change in muscular endurance

Description

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

Time Frame

At baseline and after 4 months

Title

Change in physical functioning

Description

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

Time Frame

At baseline and after 4 months

Title

Change in health related quality of life

Description

measured by a self-rated health questionnaire

Time Frame

At baselline and after 4 months

Title

Change in anxiety and depression

Description

measured by the hospital anxiety and depression scale

Time Frame

At baseline and after 4 months

Title

Change in endothelial function

Description

Evaluated with non-invasive ultrasound

Time Frame

At baseline and after 4 months

Title

Change in transthoracic evaluation of resting coronary flow velocity

Time Frame

At baseline and after 4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maria Bäck, PhD

Organizational Affiliation

Department of Physiotherapy, Sahlgrenska University Hospital, Gothenburg, Sweden

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Per Albertsson, PhD

Organizational Affiliation

Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden

Official's Role

Study Chair

Facility Information:

Facility Name

Department of physiotherapy, Sahlgrenska University Hospital

City

Gothenburg

State/Province

Select A State…

ZIP/Postal Code

41345

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

35362694

Citation

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.

Results Reference

result

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

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